One of the early signals to watch comes from PhaseV, which used the opening of the meeting to introduce its new AI-powered Enrollment Lab. The launch reflects a broader shift visible across SCOPE this year. Sponsors and CROs are moving upstream, earlier in the development lifecycle, to replace assumption-driven planning with evidence-grounded decision-making.

Enrollment remains one of the most persistent causes of trial delay. Protocols are often finalized before teams fully understand how inclusion and exclusion criteria interact with real world patient availability or with competitive trial pressure. PhaseV’s Enrollment Lab is designed to address that gap by allowing study teams to quantify true enrollment potential before protocol lock, not after sites have already struggled.

Built as a high impact extension of the PhaseV ClinOps platform, the Enrollment Lab leverages real world EHR data to model patient eligibility alongside patient level competition. Instead of relying on theoretical projections or late stage site surveys, sponsors can explore how specific protocol trade offs affect enrollment volume in real time. Small design decisions become visible for what they are, either barriers to access or opportunities to expand reach.

Raviv Pryluk, PhD, CEO and co-founder of PhaseV, described the intent as a shift from planning on paper to planning in clinical reality. By uncovering constraints early, teams can stress test their designs and ensure that studies are grounded in a verified patient population before site identification begins. That change in timing matters. It moves feasibility from a reactive step to a strategic one.

From a technical perspective, the Enrollment Lab extends PhaseV’s population first approach. Elad Berkman, CTO and co founder, emphasized the ability to translate protocol choices and competitive pressure into a clear view of real patient access. This precision guided modeling allows teams to evaluate alternative inclusion criteria, identify lightly contested patient segments, and surface geographic regions that may be overlooked by traditional planning methods.

Positioned early in the workflow, the Enrollment Lab establishes what is realistically achievable before resources are committed downstream. Once realistic enrollment potential is defined, PhaseV’s site identification tools can then prioritize investigators based on their ability to deliver against that plan rather than aspirational targets. The result is tighter alignment between protocol design, site selection, and execution.

As conversations continue throughout SCOPE, this launch is likely to gain strong traction among sponsors focused on shortening timelines without compromising scientific rigor. The message aligns with what many leaders here are emphasizing. Faster trials do not come from pushing sites harder. They come from designing studies that reflect how patients actually exist within health systems.

PhaseV is demonstrating the Enrollment Lab throughout the Summit, offering attendees a closer look at how real world data can be applied before the first site is ever activated. For an industry increasingly focused on predictability and patient centricity, this announcement sets an early tone for the news still to come out of SCOPE in the days ahead.

The post SCOPE Summit is Expected to be a Major Platform for News in Clinical Trial Innovation appeared first on Medika Life.

Scientific Progress for Patients and a Category

At the core of the ReMMi-D trial was the evaluation of CT-132, a prescription digital therapeutic, for the preventive treatment of episodic migraine. The study included 568 participants and was designed with the scientific rigor traditionally associated with pharmacological interventions. The results were compelling: patients using CT-132 experienced a reduction during three-monthly migraine days by the end of the 12-week treatment, a key metric in migraine management.

More than reducing the frequency of migraines, CT-132 showed improvements in patient-reported outcomes related to quality of life and disability, such as the Migraine-Specific Quality-of-Life Questionnaire and the Migraine Disability Assessment. These metrics matter because migraine is a neurological condition that disrupts life activities, affecting employment and social relationships. For the millions of people who have unpredictable and disabling migraines, improvement can have profound quality of life.

According to a statement by Shaheen Lakhan, MD, PhD, FAAN, chief medical officer of Click Therapeutics:“Click has developed and evaluated a first-in-class digital migraine preventive therapeutic, CT-132, in 2 separate clinical studies to demonstrate a reduction in monthly migraine days, the gold standard measure. We look forward to advancing our FDA Breakthrough Designated asset through regulatory clearance and, if successful, offering a new therapeutic option that can be delivered to any eligible patient with a smartphone, meaningfully enhancing access to care.”

Building on Existing Treatment Possibilities

Migraine remains one of the most debilitating neurological conditions, affecting more than 37 million Americans. Despite pharmacological treatment advances, many people still find their lives shaped by frequent, unexpected, debilitating episodes. Existing medications can be effective, yet they don’t work for everyone and at every instance.  Some patients struggle with adherence, side effects, or simply the anxiety around consistent relief.

CT-132 holds the potential for a new kind of intervention. Delivered by a smartphone, this digital therapeutic is designed to work alongside patients’ existing medications, augmenting their current treatments rather than replacing them. Notably, the trial was designed to evaluate CT-132 in patients already using standard migraine medications. Data from the trial points to the efficacy of CT-132 as a stand-alone intervention and suggests an additive benefit when combined with existing FDA-approved pharmacological treatments.

This approach is key to conditions like migraine, where no single treatment is universally effective. For many people, managing migraine calls for a combination of therapies—some interventional, others pharmacological, and still some behavioral. CT-132’s success demonstrates that digital therapeutics have the potential to be additive to that combination, helping people regain control over their condition.

A Potential Step Forward for Digital Health

The results of this trial are even more noteworthy for an entire sector because CT-132 is one of the first digital therapeutics to be evaluated with the same rigorous standards typically applied to pharmaceutical interventions. The randomized, double-masked, controlled study design is a gold standard in clinical research, and Click Therapeutics has brought that level of precision to the digital health category.

Stan Kachnowski, PhD, MPA, founder of HITLAB and a prominent figure in health informatics, has also echoed the importance of this transformation, stating previously that “The convergence of digital therapeutics and traditional healthcare is one of the most promising avenues for improving patient outcomes. Clinical data helps substantiate the effectiveness of digital interventions, paving the way for broader adoption in complex diseases like migraine.”

Digital health has often been touted for its innovation and potential, but the field has faced great skepticism around its ability to deliver scientifically proven results. The CT-132 trial is an answer to those on the sidelines, demonstrating how digital therapeutics—with ample clinical data—can improve people’s outcomes. The nearly 100% completion rate of daily tasks in the trial speaks to the potential for sustained patient engagement, an essential factor in the long-term success of any therapeutic intervention.

Recent FDA guidance on Prescription Drug Use-Related Software (PDURS) opens the door to a new treatment category combining digital and pharmacological interventions. The data from CT-132 adds weight to this model, opening the wide door to showing how digital therapeutics can support existing treatments and may offer added measurable benefits.

What This May Mean for Consumers

The implications of this study are significant for people and physicians who treat migraines. Beyond diagnosis, migraine is more than a medical condition—its constant presence dictates when and how people can work, study, and socialize. The Click Therapeutics data suggest a new avenue of relief that is readily accessible and shows the potential to reduce the burden of migraine in daily life.

In digital health, data is key.  Julien de Salaberry, CEO and founder of Galen Growth has often emphasized: “Data is the defining difference in how we can transform digital health into a category with the same rigor and trust as traditional biopharma.” This sentiment captures the critical role that data plays in not just validating the efficacy of digital therapeutics but also in driving their adoption and integration into mainstream healthcare​.”

Moreover, the trial was designed to be used alongside existing medications, which could assist people who feel they have already exhausted their treatment options. This is important for those who experience ongoing migraine symptoms despite the use of preventive, newer migraine medications. Digital therapeutics with demonstrated data may provide an added layer of treatment that doesn’t require the introduction of more drugs or drug-related side effects.

Future of Migraine Treatment and Digital Health

This trial’s success is more than a win for Click Therapeutics—it signals what’s possible in digital health. In demonstrating that a digital intervention can demonstrate clinical outcomes in a condition as debilitating as migraine, CT-132 may have set the bar for digital therapeutics and offers private and public payers reason to become excited about the category.

As more digital therapeutics enter the clinical landscape, their ability to integrate with and enhance traditional treatments will be crucial to their success. This trial shows that digital solutions can do more than provide “feel-good” supplementary support—they can drive measurable improvement in patient health. The data are essential to showing that hype cannot be a clinical option; digital health must deliver high evidence before being considered a serious patient option.

By setting this new precedent for clinical validation, Click Therapeutics has contributed to a more significant shift in how we think about digital health. It’s not just about innovation for its own sake—it’s about how technology can change how we manage health when designed with scientific rigor and people’s needs in mind.

The post Forget Hype – Digital Therapeutic Data Show the Category Can be Held to High Clinical Standards appeared first on Medika Life.

This move benefits Indian patients and has the potential to reshape the global pharmaceutical landscape. With India’s new policy, many multinational biopharmaceutical companies will need to reflect on how India evolves into a priority market.  

Speaking on the decision, Dr. V.G. Somani, Drugs Controller General of India (DCGI), Central Drugs Standard Control Organization, stated, “This policy shift is designed to bring the best of global medical innovation to India more swiftly. By relying on the robust data from international trials, we can ensure that Indian patients benefit from these advancements without unnecessary delays.”

This is more than just a regulatory update for multinational biopharmaceutical companies—it’s a strategic inflection point. India has long been considered a market of interest due to its significant population, favorable policy environment, and emerging middle class. Now, it has signaled its readiness to engage with the global pharmaceutical ecosystem on a new level.

The shift opens up a new market for these pharma companies. It presents an opportunity, but more importantly, a responsibility to extend their voice in India, increasing corporate brand reputation, science communication, and patient advocacy. It’s a turning point that could redefine the global pharmaceutical landscape, underscoring the weight of their role in shaping the future of healthcare.

S. Rajan, Chief Communications, Corporate Affairs and CSR officer at Roche, is among the industry leaders who applauded the GoI news: “This circular is a welcome and much-needed move. The calling out of specific drug categories will help drive a uniform and consistent understanding and avoid any delays. It is important that this is implemented well. We are hopeful that access to the latest innovations will be expedited, addressing unmet healthcare needs and benefitting Indian patients.”

Eliminating the cost barrier of conducting local clinical trials indicates that the GoI is seeking to address a public health need.  One obstacle has been removed, though others remain. Global biopharma companies still face significant challenges operating in India, primarily due to price controls impacting innovative therapies. At this time, India’s government enforces price caps that too often make it financially unviable for multinational companies to launch new, innovative drugs in this market. But it’s not impossible!

This is a favorable move to bring innovative cancer therapies and treatments for rare diseases to people in India. This remains a market of incredible potential, and biopharma companies will need to continue advancing innovative therapies and supporting them with economic solutions to make the best medicines available to more people worldwide. In the meantime, an expansion strategy to India is a medical and communication priority.

Investing in Corporate Brand Reputation

With India becoming a priority market, global pharmaceutical companies must assess how to build relationships with India’s medical and patient advocacy communities.  This is more than relying on marketing muscle. It’s about establishing a reputation as a trusted partner in health innovation and delivery in fast-emerging nations. This could involve initiatives such as collaborating with local healthcare providers, supporting patient education programs, and participating in policy discussions on health innovation and delivery in India.

Even before the GoI decision, the Indian pharmaceutical market was expected to grow to US$130 billion by 2030, up from US$42 billion in 2021, making it one of the fastest-growing health markets in the world.  The decision to embrace other nations’ regulatory moves will likely dramatically accelerate that growth.

Patrizia Cavazzoni, MD, Center for Drug Evaluation and Research, at FDA, has long tracked GoI decisions: “India’s decision to align its drug approval processes with global standards is a significant step that will foster greater collaboration. It also highlights the need for pharmaceutical companies to engage more deeply with Indian stakeholders, ensuring their corporate presence is synonymous with trust and transparency.”

Like audiences everywhere, the Indian public is increasingly discerning the corporate behaviors of those they entrust with their health.  People with urgent health concerns are excited about this decision, which will speed up access to therapies.  Companies must recognize that investing in world-class science may not be enough in the post-COVID era to secure physician support and consumer confidence.  To facilitate market entry in India requires establishing corporate identities people can trust.

The Imperative for Science-Based Communication

Effective science communication will be paramount as these companies introduce their health innovations into India. The complexities of advanced medical treatments, particularly newly approved ones, require careful explanation to health providers and the public.

Transparent, accessible communication will help demystify these innovations, fostering greater acceptance and understanding.  This also calls on major hospital provider systems that served as drug trial sites for these regulatory-approved medicines to step forward and share clinical backgrounds and best practices in patient care.

According to published studies, 87% of Indian physicians are highly engaged in continuing medical education (CMEs) and are keen to stay updated with the latest advancements in treatments and drug safety protocols, highlighting a receptive audience for apparent, data-driven communication efforts. Companies have an opportunity to lead by example, demonstrating that they are bringing innovative products to market by showing commitment to educating and empowering Indian patients and health professionals.

Dr. V.G. Somani, DCGI, emphasized the importance of clear communication in this new regulatory landscape: “Pharmaceutical companies must now rise to the challenge of effectively communicating the science behind these treatments to healthcare providers and patients. This will be crucial in ensuring that the benefits of these new therapies are fully realized.”

Patient Advocacy as a Pillar of Reputation

Most crucially, multinational pharmaceutical companies must prioritize patient advocacy in India. The recent regulatory change will undoubtedly bring some innovative treatments to the market. The policy change is a catalyst toward ensuring treatments are accessible, affordable, and aligned with patients’ needs.  However, it remains a complex challenge.  India has 1.4 billion people – as many as 400 million classified as middle class – and a diverse and complex healthcare insurance system that includes government, private, and, in some cases, a heavy reliance on consumer out-of-pocket payments.

Companies must engage with patient communities, understand their unique challenges, and advocate for solutions that address them. Organizations such as the Organization for Rare Diseases India (ORDI) and the Lysosomal Storage Disorders Support Society (LSDSS) are among the advocacy groups advocating for patients with rare diseases in India. ORDI ensures early diagnosis, treatment, and support for individuals with rare diseases, while LSDSS focuses on increasing awareness and providing access to therapies for lysosomal storage disorders.

Dr. Manjit Singh, LSDSS Executive Committee President, commented on the significance of this regulatory change: “This policy decision is a critical step forward for patients with rare diseases in India. It will help bring much-needed therapies to the market faster. Still, it also places the onus on pharmaceutical companies to ensure these treatments are accessible and affordable for all patients.”

By engaging with these patient advocacy groups, pharmaceutical companies can help amplify patients’ voices, ensuring their needs are central in developing and distributing new treatments. Over time, this will include ensuring peer-reviewed science is shared with India-based media covering health and science, prioritizing pricing strategies to ensure accessibility to patient support programs, and investing in awareness efforts so that people with these conditions understand the importance of medication adherence.

The Government of India’s decision to waive local clinical trial requirements for drugs approved by gold-standard regulatory bodies is forward-thinking and aligns with the country’s demonstrated efforts to improve health delivery for serious illnesses. Multinational biopharmaceutical companies should get the signal that India is a welcoming market ready to be at the forefront of their phyician education and patient advocacy efforts. By investing in corporate brand awareness, scientific communication, and patient advocacy, these companies can contribute meaningfully to the health and well-being of India and other emerging nations. 

One barrier to access has been lowered for innovative cancer and rare disease therapies.  In reality, others remain.  One of the biggest is that the Indian National Pharmaceutical Pricing Authority sets ceiling prices – caps – that include certain patented and innovative drugs. The pricing formula often uses a cost-plus approach, a non-starter for significant biopharma companies championing breakthrough therapies in a price-referring policy environment.  But the door to possibilities has opened wider.

In responding to the GoI welcoming decision with action, the biopharmaceutical industry can reinforce its commitment to good business, science, and patient care—a true win-win-win for all involved and a global health impact. The message is clear: Pharma companies consider the possibilities and  “Go to India!”

The post India’s Pivotal Regulatory Shift: A Possible Game-Changer in Expediting Medicines to Millions in Dire Need appeared first on Medika Life.

They drew blood at the many clinical trial sites, psychological testing was administered and the families, dutifully and in hope, brought their affected loved ones week after week. The trial would go on with hundreds of supposedly healthy, but impaired, older adults agreeing to all of it. And yet there was one piece missing in the trials and no one noticed it. What was it?

We stood at a major medical center in the New England states and talked about the patients, the test results, and the findings. Among those peering at the data were several interns writing dissertations on the disease, each one looking for a scrap on which to pin their epic piece of professional accomplishment.

I had recently returned from a trip to the Mid-West as part of my travels to various centers and I had one question that bothered me. As a psychologist, they trained me to look at people, but not confine my questions to one person, but to look at the group. After visiting at least ten centers, something became apparent to me and I had to voice my concern.

“Where’s the data on the caregivers,” I asked the group. They looked at me as though I must be falling into Alzheimer’s grip, too. Data on caregivers? No one was collecting that.

We know people don’t live in vacuums, and yet here was a multi-million dollar grant, written over weeks, that concentrated solely on testing the patient in every regard but one, the social side. Sure, they had a scale for that. How did they prepare themselves for the day? Were they able to dress, close their buttons, and comb their hair? Could they recognize themselves in the mirror? How did they interact with others?

I remembered my interaction with a couple where the wife began crying. Her husband, a former editor of a well-known journal, was frequently in the basement, fashioning bayonets from kitchen knives. The reason? He said he’d have to defend them once “they” came. Who “they” were was never mentioned, but they were out there and they’d be coming.

She had to put a bracelet with his name and phone number on it around his wrist when he went out on his bicycle now because he often got lost. Driving was out of the question after several car accidents. But the bike didn’t prove a suitable solution, either. Now, he had to wait and prepare at home and couldn’t leave her alone because they were coming.

As I sat and listened to her and many other spouses over the months of my travels, I became convinced that the protocol had a flaw; nothing about the caregivers. We didn’t ask them if they were depressed or anxious, or how they got through this incredible journey into darkness. Most of the time, they sat quietly next to the patient. This was less to help our research than to encourage the patient to take part.

I recall the husband who tried to eat paperclips because he couldn’t decide what was food and what wasn’t. Often, he’d leave the couple’s seventeenth-floor apartment, and, once out the door, he didn’t know which apartment was theirs. He’d opened the only door he found and was then locked into the stairwell.

Another patient, a woman in her 70s, once she took her eyeglasses off, couldn’t figure out how to put them back on. She also had difficulty at dinnertime, trying to eat the flatware instead of the food.

Imagine the frustration, alarm, and depression any of this can cause someone when it happens daily. How can anyone tolerate it without some help for their mental health?

We have diagnosed slightly fewer than seven million people in the United States with Alzheimer’s. If each of them has one caregiver, the number of people who require help with this disorder will be doubled. And, if things progress, thanks to medical advances, the number may quadruple in the next decade or two. But who is looking at the disease’s effects on caregivers, who, like the primary patient, are suffering from, if not with, Alzheimer’s?

I saw the mental torment of the man who had to drive his wife for almost two hours from their home to the testing center. “She kept changing the radio dials all the way,” he said, almost sobbing. “I couldn’t get her to stop.”

Then there was the extremely patient aide who had to keep coaxing an elderly woman with a promise of ice cream and lunch at a local deli. “All she wants to do is go for ice cream,” she said. The patient was delightful and used humor to answer every question. It turned out to be a common defense against memory loss and the pain it caused so many people.

One man, who had been married for almost fifty years, was on the verge of tears as he told me how his wife screamed when he tried to get into bed with her. “She keeps saying she has a husband, and he’ll come and find him there.”

Another man said that his wife was sure that someone was trying to break into their million-dollar home, so they had security systems put in at least three times. She never felt safe, whatever system was installed. And she kept firing the staff because she was sure they were stealing. In fact, she couldn’t remember where she’d put her jewelry and accused them of stealing it.

I turned to the group that day and asked what was the reason no measures were being taken for caregivers. As I recall, I said, “It’s a great resource for a dissertation any of you want to write.” I think that caught more attention than the computer screen.

Of course, that was two decades ago and we’re still trying to figure out how to help the other Alzheimer’s patients, the caregivers. How has the spread of this scary disease through social contact hurt their physical and mental health?

We have two groups that need to be assessed and treated, but we often fail to notice the second one.

The post The Forgotten Ones in the Tragedy of Alzheimer’s Disease appeared first on Medika Life.

The current clinical trial landscape

In 2020, 41% of Americans reported not knowing anything about clinical trials or their potential as a treatment option. That’s a huge percentage of the U.S. population that isn’t participating in research that could help them address serious health issues they’re facing. To correct this, we need an ecosystem-wide effort aimed at building awareness for patients, their advocates, and physicians.

Essential to this effort is a concerted, intentional approach to increase clinical trial access for communities historically underrepresented in clinical research. While there are currently 24,602 clinical trials recruiting participants in the U.S., 50% of FDA trials are conducted in only 1-2% of zip codes in the U.S., which means that millions of patients are shut out of research based solely on their geographic location or socioeconomic status. This primarily impacts people of color and those living in rural communities.

Benefits of clinical trials

It’s a status quo begging to be reimagined. Drugs can have a different effect on patients depending on their race and ethnicity, which emphasizes the importance of increasing diversity in trial participants to ensure safety and efficacy of therapeutics. And, even though every American who has taken over-the-counter or prescription medications has benefitted from a clinical trial, only 8.9% of us report being asked to participate in one.

Beyond the benefits to drug development, participation in clinical trials can provide participants with important advantages too. Patients can gain access to new treatments before they become widely available. They also receive regular, careful medical attention from physicians and other care professionals on the trial’s research team.

For some patients, participation can result in cures; one recently reported trial that evaluated a colorectal cancer treatment remarkably led to remission for every patient involved. Other recent trials have helped shrink tumors for patients with bile duct cancer and provided relief for those dealing with chronic depression. But clinical research provides no benefits if patients don’t know about them – and before we solve the participation challenge, we have to solve the awareness challenge.

Building networks has far-reaching effects

To raise awareness of clinical trials and encourage involvement, we must start by expanding the network of potential clinical trial sites and physicians who administer them. Too often, the community health centers that serve over 30 million Americans – including many members of the underrepresented groups that biopharma companies are seeking to reach and include – are simply left out of the equation.

A positive step forward would be to build up a new, expansive and inclusive network of trial sites and clinical trial investigators who can more effectively bring clinical research as a care option to their patients and communities. No one company can do this alone, but, as an industry working collectively, this is an achievable goal.

Additionally, digital technologies can be used to identify and provide information on clinical trials to people with particular diseases who may benefit most from trial participation, regardless of location. These technologies can also be leveraged to assist in communication throughout the trial process in order to enhance site design and patient experience, helping to boost engagement and prevent dropouts.  

Too many Americans don’t know enough about clinical trials to evaluate and choose participation, but we can take steps to solve that problem. We can work together across disciplines to identify and create sites in underrepresented communities, involve new physicians more directly to reach patients and encourage their involvement, and seek patient engagement and feedback throughout the trial process to enhance their experience and encourage future participation more effectively.

By empowering new communities to join in on clinical research, we can reach more patients to offer clinical research as a care option – and at the same time, enlist their help in creating more effective, safer medicines for those who will need them to live longer, healthier lives.

The post Clinical Trials As a Care Option – the Time is Now appeared first on Medika Life.

Bodybuilders have known for years the benefits reaped from exercising using eccentric motion. While your bicep might not be able to curl a specific weight, it can resist the downward movement of the dumbbell or barbell from the top position, in other words, lowering the weight. It is an excellent way to overload the muscle and bodybuilders refer to this movement as negative reps.

Typically, a person would assist you to lift the weight and you then do your utmost to resist the downward movement of the weight, fighting gravity. The result is an absolutely exhausted muscle and eccentric movements stimulate muscle growth. Bodybuilders have know this for decades. It is a go-to exercise to eke out more growth.

Science is only now starting to catch up. In a study, published in the European Journal of Applied Physiology , researchers divided people into three groups of 14 for a 5-week, twice-weekly comparison. In the group that both lifted and lowered weights, their was an increase in the maximum force they could produce on a lift by 18%, and the thickness of the biceps muscle increased by 11%.

The people who only lowered the weights nearly matched that, increasing their maximum force by 14% and muscle size by 10%. The lifting-only group increased their max force by 11%, while muscle size increase was insignificant. 

Now while you might question the results and say that clearly the group who performed both the concentric (up) and eccentric (down) movement gained more, keep in mind that the group who only performed one range of motion (the eccentric) did basically half the work, showing results that were only minimally less than their peers who performed a full range of motion. So the question then is, why do concentric movements stimulate growth to the extent they do?

Titin

The author of the study, Masatoshi Nakamura, PhD, a professor at Nishikyushu University in Japan, suggests that eccentric muscle movements produce greater neurological adaptations in the spine and brain than concentric contractions. Simply put, your nerves adapt to send increased “pull harder” signals to your muscles. A large protein called “titin” in the muscle fibers produces greater force during eccentric contractions while using less energy, and more titin could account for the increase in muscle size, commonly referred to as hypertrophy. According to Nakamura;

“Titin in the muscle fibers could be the best explanation for muscle hypertrophy, However, we believe that other factors, such as neurological adaptations, also play a large role in increasing muscle strength.”

Whatever the biological reason for the efficacy of eccentric contraction, as science plays catchup to the world of sports, bodybuilders use a simple logic to justify the movement. Stressing the muscle beyond its capabilities stimulates growth. Our bodies are amazing machines and respond according to the stress placed on them.

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Finding enough people to fill trials is one of the highest hurdles in research; nearly eight out of ten trials don’t meet enrollment deadlines. But it’s not only a challenge to find enough participants, it’s also extremely difficult to assemble a truly representative group, meaning that therapeutics are too often developed for a smaller, less diverse patient population – rather than for *all* the patients who need and will use these new medicines.

Drug developers are well aware of this critical shortcoming. And while their commitment to making trials more inclusive is increasingly expressed, what may not always be clear is the path forward with concrete, achievable steps that lead to making inclusivity a reality.

Ultimately, driving inclusivity is dependent on reimagining research infrastructure. Before we can bring a greater and more representative number of patients into the system, we need to fortify the system with new avenues of access and engagement. Clinical trials 2.0 must be about increasing access for both the physicians and patients in the communities most likely to be excluded from research today.

A recent STAT article highlights health tech startups – including Acclinate, Power, and Trial Library – that are taking important early steps to drive better engagement and community partnerships. Their efforts should be encouraging and exciting to all of us who work in clinical research or depend upon it. We are all pursuing the same mission; viewing likeminded organizations as competitors is an outmoded way of thinking and will hold back the acceleration of clinical development. The challenge of bringing more  opportunity for participation in clinical trials to historically underrepresented groups is big enough that we need all players with good ideas to share best practices and collaborate on behalf of patients.

The need for multiple approaches is laid bare in the statistics. Considering that 50 percent of clinical trials are conducted in only two percent of US zip codes, technologies that bring trials to patients, rather than patients to trials, have the potential to make clinical research more accessible to a pool of participants with greater geographic, economic, ethnic, and racial diversity. This is critical, as recently developed drugs can have a different effect on patients, depending on their race and ethnicity.

It is worth noting that if history is a teacher, technology alone won’t solve for inclusivity on a large scale; even with the apps, smart devices, and internet access that make patient participation easier, we *still* need to find these patients in the first place and engage with them in high trust environments. Successfully engaging, listening, and educating these potential participants is where our current system fails us.

The equation for successfully reimagining clinical trials – making them more representative for researchers and more accessible for patients as a care option – must put community engagement and awareness building at the center of efforts. This requires authentic, long-term investment in communities, and, importantly, increasing exponentially the number of community-based physicians and clinics participating in research as investigators and trial sites.

Strikingly, less than five percent of US cancer patients have participated in a clinical trial, despite more than 7o percent of patients expressing their willingness. A big part of the problem in accessing trials is that patients simply never find out about them, and the source with the greatest potential to convey opportunities to patients is physicians.

After some initial exposure in medical school, most physicians never take part in a clinical trial again. This means that there’s a shortage of doctors doing research, further reinforcing the concentration of clinical trials at existing sites. By identifying and enlisting the participation of physicians in communities that have been shut out of research and would benefit from it, we have the opportunity to put clinical research into the offerings of standard medical care. This enables more people from more diverse backgrounds to hear about trials and helps make it possible for them to participate.

We need a new generation of physicians to help conduct clinical research and reach patients who are willing to take part – and a new, integrated approach to research as a care option.  Existing trial sites are not numerous or accessible enough to meet existing research needs, limiting patient access and causing a dangerous chokepoint in the development of new, much-needed therapeutics. But, through a synthesis of digital remote technologies, data, and targeted community and physician outreach, we can create a network of additional clinical trial sites. These range from doctor’s offices to patients’ homes to local pharmacies and urgent care facilities, expanding the number, diversity, and location of patients in research.

Building the necessary trust across the drug development ecosystem to allow for new investigators, new sites, and new participants to access and participate in clinical trials will not be easy, but it can be done and we are already seeing signs this is happening. Embracing new site infrastructure that opens up clinical trial participation to everyone holds the promise of solving the crisis of people waiting for the development of life-saving drugs. It is worth the effort to evolve our process and broaden our circle of inclusion; partnering with these physicians, patients, and their communities to accomplish our shared goals of improving and extending lives looks to be the next great innovation in clinical trials.

The post Increase Inclusivity in Research by Reimagining Clinical Trials appeared first on Medika Life.

During 2015–2018, 13.2% of Americans aged 18 and over reported taking antidepressant medication in the past 30 days. Antidepressant use was higher among women than men in every age group. Use increased with age in both men and women. Almost one-quarter of women aged 60 and over (24.3%) took antidepressants.

Over the past several decades, as antidepressant use increased, patients (and the healthcare profession) have believed that depression was due to “a chemical imbalance” of the neurotransmitter serotonin. With that thought in mind, researchers concocted numerous antidepressants to manipulate serotonin actions in a patient’s nervous system by enlisting a pattern of blocking (antagonist) or facilitating (agonist) the neurotransmitter’s exertion.

The belief in serotonin’s ability to control depression was further facilitated by flawed research that cherry-picked results, didn’t publish failed efforts on its behalf, and the marketing needs of pharmaceutical companies. To say that depression was produced by “a chemical imbalance” served several purposes.

The first factor was the wish of patients to believe they were victims of their biology, not their negative cognitions or lifestyle choices, or other factors. The second major factor was to produce blockbuster medications.

Prozac was incredibly successful (read “Listening to Prozac ”) because of efforts to promote it. Its problems, however, were understated or not stated at all during prescribing. After the introduction of Prozac into the pharmaceutical armamentarium, several groups of medications were based on similar theoretical beliefs with slight chemical changes.

Authors quickly jumped on the bandwagon and began producing books and articles that ingrained this chemical imbalance belief further. The writers offered ways to reverse it with foods, exercises, or natural products.

A New View of the Theory

Thanks to a meta-analysis research project, the cat may be out of the bag. But, after all these years and before this research, didn’t people wonder why their antidepressant wasn’t working? Was serotonin not the culprit it had been viewed as in the past?

And why did placebos work when antidepressants didn’t? The new effort at seeking out more about serotonin and whether it was the culprit in depression has been eye-opening.

Our comprehensive review of the major strands of research on serotonin shows there is no convincing evidence that depression is associated with, or caused by, lower serotonin concentrations or activity. Most studies found no evidence of reduced serotonin activity in people with depression compared to people without, and methods to reduce serotonin availability using tryptophan depletion do not consistently lower mood in volunteers.

While the review would seem to set the serotonin theory aside, there may still be individuals who could benefit from these medications. As one supervisor I had during my internship once told me, even a sample of ONE is sufficient for research. If someone, anyone, benefits, it’s the proper medication for them.

Dispensing millions of pills must surely hit one patient or more with a special need. Depression remains a serious, misunderstood disorder that ravages lives and results in suicide for too many. WHO notes that up to 280 million people worldwide suffer from depression.

In 2016, suicide ranked as the 10th leading cause of death among Americans. It is the second leading cause of death for those under 35.

Bringing some control over the illness/disorder remains a primary goal for anyone in healthcare because of the millions who suffer from depression and die because of the emotional pain it causes.

The post Flawed Research, Clever Marketing, and the Failure of a Depression Theory appeared first on Medika Life.

The introduction of Walgreens clinical trial offerings coincides with recent steps taken by the U.S. Food and Drug Administration to increase racial and ethnic diversity in clinical trials given 20 percent of drugs have a variation in responses across ethnic groups¹, yet 75 percent of clinical trial participants are white, while only 11 percent are Hispanic and fewer than 10 percent are Black and Asian².

“Walgreens trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable,” said Ramita Tandon, chief clinical trials officer, Walgreens. “Through the launch of our clinical trials services, we can provide another offering for patients with complex or chronic conditions in their care journey, while helping sponsors advance treatment options for the diverse communities we serve. This is yet another way we are building our next growth engine of consumer-centric healthcare solutions.”

Patient recruitment and enrollment remain challenges in clinical trials, further exacerbated by the COVID-19 pandemic. Nearly 80 percent of trials fail to meet their enrollment goals in the stated timeframes, often contributing to costly delays.  Walgreens is addressing these challenges and improving the overall clinical trial experience by rapidly scaling three portfolio-integrated, patient-centric service lines:

• With Walgreens patient reach and access to an extensive foundation of pharmacy and patient-authorized clinical data, the company can proactively match diverse patient populations to trials across a range of disease areas based on race, gender, socioeconomic status and location. By leveraging a tech-enabled approach to patient identification and creating a large registry of clinical trial participants, Walgreens will reduce the time it takes to match eligible patients to clinical trials.

• Walgreens is addressing access barriers through a compliant, validated and secure decentralized clinical trial platform built on a rigorous compliance and regulatory framework to ensure patient privacy and security. This approach leverages owned and partner digital and physical assets, including select Health Corner and Village Medical at Walgreens locations, to directly engage patients at home, virtually or in-person. Synergies with AllianceRx Walgreens Pharmacy, as well as investments made by Walgreens Boots Alliance in CareCentrix and Shields Health Solutions, will also support new clinical trials approaches, particularly for specialty indications. This innovative operating model will accelerate patient searches, simplify workflow and enable a faster and more representative collection of trial data.

• Walgreens is building on a legacy of delivering high-quality, real-world evidence to unlock value in therapeutics and help improve health outcomes. Through a robust foundation of real-world insights, Walgreens can support sponsors’ drug development strategies, inform clinical trial designs, optimize trial execution and improve diversity in trials. In fact, real-world insights delivered through the Walgreens COVID-19 Index helped inform national and local health decisions and plans.

More than half of Walgreens nearly 9,000 stores are located in socially vulnerable areas. When combined with Walgreens customer relationships, digital offerings that keep patients connected to care and partnerships with national and local organizations, Walgreens has a proven ability to break down barriers to health engagement and access among diverse patient populations. Most recently, the company hosted vaccine clinics and events to address vaccine hesitancy with help from more than 750 diverse, community-based partners, and administered approximately 40 million COVID-19 vaccines to underserved communities throughout the pandemic.

Pluto Health™ Collaboration Enhances Experience With Comprehensive Health Insights

One of the partners for the Walgreens expanded healthcare offering will be Pluto Health, a multi-layered, smart care coordination service that unifies siloed health information from multiple places (such as medical records, social determinants of health, insurance claims and more) within 30 minutes. The Pluto Health team then evaluates patient health information with the recommended clinical care guidelines and social determinants of health data to identify and close any potential gaps in care. This helps ensure every patient receives the best possible care through up-to-date screenings, vaccinations and other health interventions, such as clinical research as a care option.

“Pluto Health was co-created within the healthcare community to make the provision of care achievable and more equitable for more people with better care coordination,” said Joy Bhosai, MD MPH, Co-Founder, CEO Pluto Health. “As a part of our primary goal to coordinate care and support patients on their terms, we are thrilled to play a part in making the latest medical advances more accessible. It’s time to accelerate healthcare access for all patients, from all walks of life, and from anywhere in the nation.”

The post Walgreens Launches Clinical Trial Business to Address Industrywide Access and Diversity Challenges and Redefine Patient Experience appeared first on Medika Life.

Primary endpoints demonstrated 6-8x increased odds of smoking abstinence with cytisinicline compared to placebo

Cytisinicline was well tolerated with single-digit rates of adverse events observed

Achieve Life Sciences, Inc. (NASDAQ: ACHV), today announced positive topline results from the Phase 3 ORCA-2 trial of cytisinicline. ORCA-2 was designed to evaluate the efficacy and safety of 3mg cytisinicline dosed 3 times daily for a period of 6-weeks or 12-weeks compared to placebo in 810 adult smokers (randomized 1:1:1). Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial.

The primary endpoints for ORCA-2 were biochemically verified continuous abstinence measured during the last 4 weeks of treatment. Both the 6- and 12-week cytisinicline treatments demonstrated significantly better quit rates than placebo with odds ratios of 8.0 and 6.3, respectively.

• Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.
  
• Subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 3-6 was 25.3% for cytisinicline compared to 4.4% for placebo.

ORCA-2 participants were an average age of 54 years, smoked on average 20 cigarettes per day at baseline, and had a median smoking history of 38 years with 4 prior quit attempts.

“Cytisinicline demonstrated impressive efficacy for smoking cessation compared to placebo in this trial, the first large randomized clinical trial conducted in a U.S. population,” said Dr. Nancy Rigotti, Professor of Medicine at Harvard Medical School, and Principal Investigator of ORCA-2. “The trial is also notable as the first one to test the long-term efficacy of a new cytisinicline dosing schedule that has not previously been tested in a large population.”

The secondary endpoints measured continuous abstinence after treatment out to 24 weeks. Both the 6- and 12-week secondary endpoints demonstrated significantly better quit rates for cytisinicline treated subjects than placebo. The continuous abstinence rate from week 9 to 24 was 21.1% for the 12-week cytisinicline arm compared to 4.8% for placebo, with an odds ratio of 5.3 (p<0.0001). The continuous abstinence rate from week 3 to 24 was 8.9% for the 6-week cytisinicline arm compared to 2.6% for placebo, with an odds ratio of 3.7 (p=0.0016).

Cytisinicline was well tolerated with no treatment-related serious adverse events reported. The most commonly reported (>5% overall) adverse events for placebo, 6-week cytisinicline, and 12-week cytisinicline were:

• Insomnia: (4.8%, 8.6%, 9.6%)
• Abnormal dreams: (3.0%, 8.2%, 7.8%)
• Headaches (8.1%, 6.7%, 7.8%)
• Nausea (7.4%, 5.9%, 5.6%)

“These strongly positive results are extremely encouraging, and we are thrilled for the successful quitters, whom after decades of smoking and multiple attempts, were finally able to kick the habit thanks to cytisinicline and the ORCA-2 trial,” commented John Bencich, CEO of Achieve Life Sciences. “These data confirm that cytisinicline, if approved by the FDA, has the potential to become the first new agent approved in nearly two decades and an important treatment option for smoking cessation, which is much needed given the limitations, particularly the significant side effects associated with existing agents. We would like to thank the investigators, healthcare providers, and subjects whose commitment and efforts to ORCA-2 made this trial a success.”
        
In connection with the positive ORCA-2 trial results, the Company has also received approval from Silicon Valley Bank to access the remaining capital available under its $25.0 million debt facility put in place in December 2021. Per the terms of the agreement, the remaining $10.0 million of commitments are being made available to the Company through April 30, 2023. Amounts drawn under the remaining commitments will incur interest at the greater of 3.50% and the WSJ prime rate, and will be subject to interest only payments through April 30, 2024, and then amortize fully over the following 24 months. No amounts have been drawn at close and the Company will have the discretion to make draws under the facility through April 30, 2023. Additional terms of the agreement can be found within the company’s Form 8-K filing issued on April 27, 2022.

Additional information on cytisinicline and the ORCA program, including the ongoing Phase 3 ORCA-3 trial, can be found at www.achievelifesciences.com and www.orca-3.com.

About ORCA-2
The Phase 3 ORCA-2 trial evaluated the efficacy and safety of cytisinicline as a treatment for smoking cessation in 810 adult smokers at 17 clinical trial locations in the United States. Smokers were randomized to one-of-three treatment arms to receive either placebo or 3 mg cytisinicline taken three times daily for a period of either 6 or 12 weeks. Subjects were monitored for smoking abstinence for 24 weeks post randomization and received standard behavioral support for the duration of the trial. ORCA-2 is the first randomized Phase 3 clinical trial to show a smoking cessation benefit and potential for a new FDA-approved treatment option in nearly two decades.

About Achieve and Cytisinicline 
Tobacco use is currently the leading cause of preventable death that is responsible for more than eight million deaths worldwide and nearly half a million deaths in the United States annually.^1,2 More than 87% of lung cancer deaths, 61% of all pulmonary disease deaths, and 32% of all deaths from coronary heart disease are attributable to smoking and exposure to secondhand smoke.² Achieve’s focus is to address the global smoking health and nicotine addiction epidemic through the development and commercialization of cytisinicline.

Cytisinicline is a plant-based alkaloid with a high binding affinity to the nicotinic acetylcholine receptor. It is believed to aid in smoking cessation by interacting with nicotine receptors in the brain by reducing the severity of nicotine withdrawal symptoms and by reducing the reward and satisfaction associated with smoking.

Cytisinicline is an investigational product candidate being developed for treatment of nicotine addiction and has not been approved by the Food and Drug Administration for any indication in the United States. For more information on cytisinicline and Achieve visit www.achievelifesciences.com.

The post Achieve Life Sciences Announces Statistically Significant Smoking Cessation Results in Phase 3 ORCA-2 Clinical Trial of Cytisinicline in Adult Smokers appeared first on Medika Life.