Real-world evidence (RWE) captures health data from outside controlled clinical trials, such as wearable devices, patient forums, electronic health records, and symptom tracking apps. It reflects the daily realities of individuals managing chronic conditions, navigating medications, and seeking answers when the system fails to provide clarity.

As Yael Elish, one of the founders of the mega crowdsourcing transportation platform WAZE and now CEO and Founder of the patient RWE platform StuffThatWorks, has said, “Patients will never have a seat at the table until their data is considered part of the navigational guide for new medicines, devices, and indications of use.”

She’s right, but perhaps we must push ourselves to a new level of acknowledging why we are pursuing new approaches to care. This is not just about offering patients a seat at the allegorical table. It’s about acknowledging that the table of discovery and development exists for their benefit. The science, systems, and research all exist to serve their needs. Their voices and their lived experiences must inform the path forward.

A Silent Majority Speaks: The Data We Ignore

A recent survey conducted by StuffThatWorks, which gathered insights from more than 15,000 patients across 145 medical conditions, revealed a staggering disconnect. 92% of patients expressed a willingness to participate in clinical trials. Yet, 84% said they had never been asked, never invited to the table of health innovation.

This isn’t a communications oversight—it’s a justice issue. The system is failing those it claims to serve. Patients are ready to contribute. Some are out of options and want concrete action steps. They are waiting to be seen, heard, and engaged. Their personal care and experiential data they offer doesn’t just enrich our understanding—it recalibrates it.

“The Pharma Industry’s efforts to include patient voices have been a step in the right direction; however, they remain on a very small scale today,” notes Caroline Redeker, chief strategy officer at Advanced Clinical, a leading clinical research organization. “Interacting with a minimal number of patients without scale does not accurately represent the full patient population with the condition.  Using available static data (claims, EMR) detached from the patient covers the ‘what’ of patients – how many, where, with claims or treatments of a condition, and mostly in the US.”  

Redeker adds: “The more important factors in trial design include the ‘why,’ including most bothersome symptoms, effectiveness of treatments, regional differences, comorbidity considerations, and other valuable information to accurately design the right trial.  The ‘why’ information can only come directly from the patients.  The future will bring patients and their organized data to the table and include patient insights from all over the globe.”

Real-World Realities: Lessons from Ehlers-Danlos Syndrome

Consider Ehlers-Danlos Syndrome (EDS), a connective tissue disorder with 13 recognized subtypes, ranging from the more common hypermobile form to the rare, life-threatening vascular subtype. Each type carries a distinct constellation of symptoms and risks. Some people face chronic dislocations and mobility challenges, while others live with the daily fear of spontaneous organ rupture.

A single disease name masks and encompasses a spectrum of experiences. Standard clinical trial models often can’t keep up with that complexity. But thousands of patients with EDS are documenting their treatment responses, flares, and management strategies across RWE platforms such as StuffThatWorks—building a picture of this disease that’s as varied, inclusive and individualized as the people living with it.

“The StuffThatWorks survey expands the usual definition of real-world data to include this novel direct patient-inputted database,” says George Sands, MD, FAAN, FAHA, FACC, a former senior director at Pfizer and noted advocate for collaborating with patient communities  “Patients and patient advocacy groups want to partner with sponsors, whether pharma or academia, and to be fully represented in research endeavors. This is very different from sponsors looking to recruit and retain research participants more fully. This is about collaborating.” 

Dr. Sands adds, “Additionally, it is important to have all different patient populations, including people of color, so their data is included in the trials and can be used for clinical care. Otherwise, clinicians have to extrapolate based on those included in the trials; it doesn’t always work exactly.” 

That kind of data, born of day-to-day life, isn’t just complementary to clinical trials. It completes a fuller picture essential for developing effective treatments. Without it, we risk designing therapies that help in theory but fail in practice.

From Inside-Out to Outside-In

Much of medicine’s traditional approach to research is inside-out, starting with what companies aim to prove and working outward through the trial process. That’s not inherently wrong—it is how rigorous science is structured—but that is not enough.

We must also embrace outside-in realities as part of the innovation journey, where patients’ lived experiences inform what we explore, how we measure success, and who we prioritize.

Craig Lipset, founder of Clinical Innovation Partners, and co-chair of the unifying NGO/research industry Decentralized Trials & Research Alliance, and former Head of Clinical Innovation at Pfizer, has long championed a rebalancing of power in clinical trials.

“To earn and maintain trust, research participation must become a symbiotic relationship powered by a bidirectional flow of data and learnings, says Lipset. As patients share insight into study design, bring real-world data into trials, and share experience that shapes new endpoints, sponsors must commit to ensuring that study data and results are flowing back.”

That vision is becoming increasingly possible. With technologies that enable decentralized trials, remote monitoring, and electronic patient-reported outcomes, we can now collect real-world data at scale. However, that only matters if we respect what the data tells us and are willing to let patient experiences guide the research agenda. We give lip service to the importance of patient voice in biopharma research and marketing, but do we see them as “customers” of innovation?

The Science of Listening

Real-world evidence is the patient’s language—a narrative built not in labs but in lived experience. It’s not peripheral to science—it is science when equity is the goal. When patients share their stories, whether on online platforms, through wearables, or in digital symptom trackers, they are offering far more than an anecdote. They are offering insight. They contribute to the science of what works, for whom, and under what conditions.

And when we listen, we don’t just become better researchers. We become better healers.

We stand at a pivotal moment. Innovation can either deepen the divide between patients and science or bridge it. Real-world evidence is the support structure for that bridge. It offers us the opportunity to democratize discovery and reimagine research collectively.

Reflects StuffThatWorks Elish, “The current methods of involving patients in the clinical and health spaces are doomed to failure.  Patients’ voice will be heard ONLY when turned into organized data, at scale.  Because no one can argue or ignore organized data at scale. Once that’s accomplished, the integration of patient voice will proliferate and become easily accessible to everyone in multiple forms, including a simple AI-based chat question.  We are doing that at StuffThatWorks; it’s core to our mission and vision.” 

Ultimately, the patient wants to be invited to the table—but not as a token guest. Without them, there is no table worth setting. The patient is not a peripheral player in this system—they are the system’s purpose. They are not guests in the system. They may not be the core customer of the health system, a universe that centers around its economic viability. Still, in the world of health system kinetics, where we examine the relationship and priority of the sector pieces, they are the reason we unite to invent solutions to confront disease, despair and death.  And the future of medicine depends on how well we recognize that truth.

The future of medicine hinges on one choice—do we continue treating patients as passive subjects, or as co-creators of the care that might save their lives? That’s not philosophy. That’s leadership.

Interested in this topic – here is more to explore:

Aman Gupta: Patient Inclusivity: The Missing Piece In Pharma’s Global Innovation Strategy

The Need for High Quality, Reliable Information that is Data-Driven – A Conversation with Yael Elish

Gil Bashe: Real-World Evidence Unlocks Consumer Voice to Improve Care

The post How Real-World Evidence Proves the Power of Patient Engagement appeared first on Medika Life.

The Marfan Foundation is the world’s most extensive patient and professional community addressing the needs of people living with genetic aortic and vascular conditions, serving one million people with educational materials and reaching 3.2 million people in the digital space annually.

The Marfan Foundation will play a crucial role in informing individuals living with Marfan, Loeys-Dietz, Vascular Ehlers-Danlos syndromes, and related conditions about the resources and community dialogue offered by StuffThatWorks. This collaboration will enable StuffThatWorks to develop a comprehensive strategy for engaging non-profits with the goal of ultimately benefiting the global patient community.

“We’re honored to have been selected as the first non-profit to align with StuffThatWorks to elevate community members’ voices, foster additional personal empowerment, and advance access to potential learnings that may be derived through global self-reporting,” said Michael L. Weamer, CEO of The Marfan Foundation.

StuffThatWorks’ operational value is that patients’ crowdsourcing information can highlight issues that need to be addressed from the patient perspective as well as spotlight various treatment options, side effects, and obstacles to care: “Understanding how patients experience various treatments is one of them,” according to their website. “The Marfan Foundation has a steadfast commitment to scientific rigor and fostering a strong global community. Operationally, the Foundation leverages world-class experts to focus on research and best practices in patient engagement and empowerment,” says Yael Elish, CEO of StuffThatWorks. “The Foundation’s investment in basic and applied research and translating these understandings into patient support and education reinforces that real-world data is valued in applications with the potential to advance treatments and quality of life.”

“We’re enthused to share what we know about specific non-profit needs and goals while we learn more about the possibilities StuffThatWorks’ patient-centric knowledge-base will offer,” said Weamer.

About 1 in 5000 people have Marfan syndrome, including men and women of all races and ethnic groups. Roughly 3 out of 4 people with Marfan syndrome inherit it. There is a 50 percent chance that a person with Marfan syndrome will pass along the condition each time they have a child. Because connective tissue is impacted and found throughout the body, Marfan syndrome can affect many body parts. Features of the condition are most often found in the heart, blood vessels, bones, joints, and eyes. Some Marfan features – for example, aortic enlargement (expansion of the main blood vessel that carries blood away from the heart to the rest of the body) – can be life-threatening. People living with Marfan syndrome and related conditions have a 250 times greater risk of aortic dissection than the general public. The lungs, skin, and nervous system may also be affected.

About StuffThatWorks

Created by Waze founding team members, StuffThatWorks uses crowdsourcing and AI to empower patients to transform their experiences into organized, large-scale structured Real-World Data needed for research. StuffThatWorks is the home to three million members across 1250 condition communities that have shared 1.3B data points. Now the largest organized Patient Level Real World Data platform, StuffThatWorks is differentiated by its expansive data collection, structuring, and organization of accessible information. The unique proprietary data set and unique AI and powerful Chat GPT-like capabilities enable the generation of insights for research, market access, and drug development.

Crowdsourcing Treatments that Work | Community Research | StuffThatWorks

About the Marfan Foundation

The Marfan Foundation is a global nonprofit organization that empowers people with genetic aortic and vascular conditions to foster optimal quality of life and longevity while building community. We save lives through research and education, enabling healthcare providers to offer the best-quality treatment and helping to foster mental and physical wellbeing. We serve communities impacted by Marfan syndrome, Loeys-Dietz syndrome, Vascular Ehlers-Danlos Syndrome, and related conditions. To learn more, visit marfan.org or meet us on social media:

Facebook | Instagram | LinkedIn | X (Twitter) | Threads | YouTube | TikTok

The post StuffThatWorks and The Marfan Foundation to Engage in Pilot Program 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.

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.

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.

There are specific types of sampling for clinical trials or any research, and they are random, systematic, stratified, clustered, and convenience sampling, and the sampling type may result in older patients being excluded. There are other types of sampling, but these are the more usual. Convenience sampling is one where it is probably easiest to get the sample size required.

Of course, each clinical trial will also, in addition to their sampling method, have rule-in and rule-out criteria eligibility. Here, the principal investigator makes decisions based on factors they wish to control, such as a history of alcoholism, familial sudden death syndrome, or other medical conditions. Age can be an important concern and serve as a “rule-out.”

Of course, institutional review boards bear responsibility here, too. Questioning by board members regarding the reason for not including older patients is mandatory.

Every patient has the potential to bolster our knowledge and research base if we see past our bias. And what would a specific bias be in these cases? Are we selecting in only those who have many decades of life left and tossing aside those with possibly one decade of life left to them? How much is a decade of life worth these days?

The Ethos of Medical Ethics

Clinical research trials are essential for any headways to be made in the many wars medical science is currently engaged in worldwide for various diseases. It would stand to reason that these research trials would be comprised of individuals of all ages, ethnicities, and gender groups to ensure that we are utilizing a representative sample to come to valid results. But that doesn’t seem to be the case with two groups, particularly older adults and Black individuals.

Regarding Black individuals, we know a long history has contributed to a reluctance to engage in clinical trials. No one needs to tell us about the horrific trials in the South with Black men who thought they were being treated for a sexually transmitted disease (syphilis) when, in fact, they were being followed to catalog the progression of the disease and their deaths. They never received the medicine that would have cured them, penicillin.

Despite mandates by the federal government to ensure the inclusion of women and minorities in all federally funded research, African Americans continue to participate less frequently than Whites. Lower participation rates among African Americans have been reported across various study types (e.g., controlled clinical treatment trials, intervention trials, as well as studies on various disease conditions, including AIDS, Alzheimer’s disease, prostate cancer, and other malignancies, stroke, and cardiovascular disease).

Medical history must always keep that in the record books and understand the impact it has had on generations of Blacks. There are other examples of equally unethical research or experiments on this group.

Now, we face another difficulty or impediment, and that is in the area of age disparities in some clinical trials, but cancer is of utmost importance.

Cancer and the Aged Patient

Statistical census data released annually by major research entities indicate that 10% of those over the age of 65 have some form of cancer. The latest census figures for the United States suggest that there are over 65 million people in this age group, both male and female. Logically, this indicates almost seven million in that group have cancer.

Worldwide the World Health Organization indicates that each year 10 million people die from cancer worldwide, or one in six. In the US, in the 60–70-year-old group, cancer is the second most common cause of death.

The FDA has noted an underrepresentation of older adults in cancer-treatment trials. The National Cancer Institute’s data show decreasing enrollment in trials both FDA and SEER with advancing age. At ages 75 and greater, only 9% of research samples were in this age group. At 65, it was 36%.

By 2030, it is estimated that 70% of people over 65 will have some form of cancer. If that isn’t a compelling reason to begin enrolling this population into cancer clinical trials, I have to question the trials.

Arrogance and Ignorance in Research

I have to question the rationale for the trials, who is underwriting the trials, the background of the principal investigator in terms of ageism potential, and how significant the trials would be in a rapidly aging world. We cannot deny that the silver tsunami is upon us and will require billions of dollars of care for these patients.

If we do nothing or little to provide innovative, new treatments garnered from new research, we will find ourselves trying to swim without any floaties to support us.

One research paper indicated that if we fail to include this population in cancer clinical trials, there will be a lack of generalizability that can lead to challenges in treatment decisions for OA (older adults) and concerns regarding health inequity. Do older adults receive equal medical treatment today? I question that.

The editors indicated that trial structure, design, physician perspective, and patient or caregiver perspectives must be carefully evaluated and included as required. They call for actionable recommendations to address the challenges these types of cancer trials face, which may have been ignored in the past.

There is no room for ageism in clinical research, and when found, it must be addressed as strongly as possible because lives are on the line. To do less is extreme arrogance and ignorance in the face of what is coming down the road. No gods are working in medicine, and everyone must adhere to the strictest ethical guidelines possible and care for those who may have, either on purpose or thoughtlessly, fallen through the safety net.

Yes, I have heard chiefs of service refer to older patients as PIAs (no, it’s not Prolonged Infantile Apnea), a term which should have been erased from medicine many decades ago but is still held close in the minds of those who live in the past.

The post No Hope for Older Patients in Cancer Clinical Trials Thanks to Bias appeared first on Medika Life.

It may seem an almost impertinent question if you’re a drug developer. After all, the often-used response that investigators give to trial participants has been ‘good enough’ for decades: patients’ health may benefit from participation, and, whether they are in the active or placebo arm of a study, they have the satisfaction of knowing that they helped others with their disease by taking part. It’s true, and yet, today, it feels as though it falls short.

Patients living with life-threatening diseases have all their skin in the game.  Their time equals life, the ultimate valued commodity. These are the ready, motivated participants for clinical trials, and in exchange for their time and data, they and the organizations that advocate on their behalf should benefit from drug development through royalties that directly fund future research and advocacy priorities. When communities’ needs converge, great change is possible.

More Efficient Fundraising Drives More Immediate Patient Benefit

For decades, patient advocacy groups have looked to galas, walks and events as the prescribed formula to raise essential funds.  These gatherings are important opportunities to rally society, unite allies and sustain community, but they also take time, and the need for speed calls for creativity in advancing science.  Advocates should look beyond filling tables of 10. Their strategic plans should include partnering with contract research organizations (CROs) as pathways to advance drug development as well as fostering awareness, advocacy and treatment as part of their missions. 

The currency that makes this possible is the exchange of data, which are essential to all therapeutic advances. That requires patient advocates to think differently about working within their communities and with academic centers, contract research organizations and industry.

“The need for diversity and greater decentralization in clinical trials will requires new kinds of data exchanges with patients,” notes Irfan Khan, MD,  CEO, Circuit Clinical. “With our industry’s need for these novel collaborations also comes the chance for real change.”

Data as Currency

Amazon, Apple, eBay, Facebook, Google, and a host of other immense social communities prove repeatedly that data are essential currency for economic success. Giants in consumer data analytics get smarter by tracking online information, transforming searches into “what to buy next” prompts. Whether we accept or reject their approach to user privacy, we must also acknowledge their mastery of data monetization.

The concept should be nothing new for academic research centers, which have long monetized health data. Google Scholar and University of California-Berkeley Professor Dawn Song created a secure path for patients to share data with researchers by launching software company Oasis Labs. Why can’t patient groups also benefit from this approach?

Paddy Padmanabhan, co-author of the best-selling book Healthcare Digital Transformation — How Consumerism, Technology, and Pandemic are Accelerating the Future writes, “As traditional healthcare enterprises confront emerging competition from non-traditional players, some of them have started realizing the competitive advantage they have in the form of vast amounts of data they have on healthcare consumers’ medical histories.” Those ‘non-traditional players’ don’t just mean Amazon or Google — they may well be the patients themselves organizing to ensure they have greater sway in setting clinical priorities.”

Facilitating — and Funding — Innovation

Patient advocacy groups can build models that amass more information for clinical research and even work to fund these initiatives as partners. Before planning their next virtual gala or whiteboarding ideas on determining their “Ice-Bucket Challenge” moment, they should also look at how the ALS Association applied those monies to increase research funding and accelerate clinical possibilities. Beyond simply providing capital to fuel innovative ideas, they became drug start-up companies’ investment partner.

There are many ways to use data to create mutually beneficial partnerships. The GenTAC Alliance (National Registry of Genetically Triggered Thoracic Aortic Aneurysms and Related Cardiovascular Conditions), launched by NHLBI and NIAMS, enrolled more than 3,600 patients between 2006 through 2016. By putting this registry to work, The Marfan Foundation is looking to partner with biopharma companies to fulfill its patient-support mission to discover new treatments and cures for life-threatening genetic aortic conditions.

Biopharma companies already want patients and their communities to have a seat at the table, but collaboration is more than simply communicating. It’s about creating common ground for mutual success. Economic models that address multiple interests may be a new remedy to make that happen more frequently, and groups such as Let’s Win for Pancreatic Cancer and The Christopher and Dana Reeve Foundation have taken on pinpointing cutting-edge research that may sustain life, bringing collaboration with drug developers to another level.

The culture of drug development is shifting. In the new edition of Alzheimer’s Disease Drug Development – Research and Development Ecosystem, edited by Drs. Jeffrey Cummings, Jefferson Kinney and Howard Fillit, there is a chapter dedicated to “The Role of Professional and Patient Advocacy in Advancing Alzheimer’s Disease Drug Development.” I was privileged to co-authored this chapter with neurologist and psychiatrist Amir Kalali, MD where we note: “While fund-raising efforts such as walks, galas, golf outings, and conference sponsorships still occupy their workflow (of advocacy groups), the focus on these monies in the digital era has shifted from awareness building to being leading sources of research funds.”

Can Patient Advocates be Agents for Patient Data?

Companies such as Hu-manity.co pose an essential answer to the question, “who owns your data?” Its Founder and Board Chair Richie Etwaru wrote, “…the simple idea that we should put the consumer (the patient) into the center of the healthcare data supply chain with ownership rights literally at their fingertips is both powerful, and timely.”

This is a movement in the making. Biopharma companies might find that by advancing this idea, they can accelerate mutual interests. Craig Martin, CEO for Global Genes Foundation Alliance, a rare disease advocacy community with more than 600 member organizations, advocates for a more inclusive partnership between patient groups and the biopharma industry.

Industry so far seems receptive. Led by Co-Chairs Amir Kalali, MD, and Craig Lipset, The Decentralized Trials & Research Alliance, a 150+-member organization uniting industry, academic centers, contract research organizations (CROs), regulators and patient advocates, is sparking the conversation among a research community that speed, diversity and inclusion in bringing new therapies to market — and to patients — is in everyone’s best interests.

It’s Not About Going Virtual — It’s About Collaboration and Mutual Benefit

Apple, Google and Microsoft are dominant companies to follow for trends and developments in technology. But they are also advancing collaborative economic models that drug developers and patient communities should emulate. They pioneered the idea of mining unpolished data and turning it into a new currency for commerce.

All drug development is built on clinical research, in which patients’ participation is essential in defining safety and efficacy. Increasingly patient groups are realizing the vital importance in the role they play. What might happen if industry more equitably includes patients and their advocates? Could timelines be advanced if patient groups had benefits similar to research sites and CROs? What might happen if Food and Drug Administration Advisory Boards were required to meet with patient advocacy ambassadors to accountably explain how their recommendations impact future care and innovation?  

We know the past.  We have attended enough patient advocacy galas to acknowledge the need to learn from other successful models. Deploying data is the obvious, simple economic pathway for accelerating decision-making and growth. But, less obvious, data are also the currency that may enable patients and advocacy groups to accelerate their own missions, becoming full-fledged partners in driving innovation and drug development, while becoming stronger, more sustainable communities.

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Initiative is part of the BMS Foundation commitment to health equity and diversity and inclusion made last year

Applications are also now open for second cohort to begin in October 2022

PRINCETON, N.J.–(BUSINESS WIRE)– The Bristol Myers Squibb Foundation (BMSF), together with its partners, National Medical Fellowships (NMF) and the American Association for Cancer Research (AACR), today announced the first group of 52 physicians selected for its Diversity in Clinical Trials Career Development Program (BMSF DCTCDP). The 52 early-stage investigators are the first of 250 community-oriented clinical trialists who will be trained through the program by 2027.

The 52 physicians selected by an independent selection committee are an accomplished group working at a broad range of healthcare institutions in 22 states across the U.S. The physicians include 34 women and 18 men who represent a diverse cross section of races and ethnicities and bring a widely varied perspective and range of experiences to the program, as well as to their therapeutic focus areas of cancer (hematologic or solid tumors), immunologic disorders and cardiovascular diseases.

“I’m awed by this inaugural group of clinicians, who have demonstrated their passion for and dedication to addressing the disparities in clinical research through community engagement,” said Robert A. Winn, M.D., Director, Massey Cancer Center, Virginia Commonwealth University, and Chair of the National Advisory Committee of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program. “And, I’m confident that when they complete this program, these scholars will have the skills not only to conduct high impact clinical trials, but also to work within communities to build trust with at-risk populations, getting past the fear and skepticism that can often exist, to give the underserved better access to this important tool in healthcare research.”

The BMSF DCTCDP was launched as one of a number of different health equity and diversity and inclusion commitments made last year by the Foundation and its donor, Bristol Myers Squibb.

Building on the Bristol Myers Squibb Foundation’s legacy of promoting health equity and improving the health outcomes of populations disproportionately affected by serious diseases, the BMSF DCTCDP was launched to address the lack of diversity in clinical trials in the U.S. In fact, evidence shows that nearly 80% of patients taking part in clinical trials are white.¹

Through the BMSF DCTCDP, participants will be trained as world-class clinical research scientists with additional knowledge, skills and competencies in effective community outreach and engagement. This new generation of physician investigators will have the potential to transform the clinical research landscape by conducting clinical trials designed with the goal of increasing the diversity of their participants.

A Unique Program Focused on Long-term Outcomes

“The ultimate aim of this program is to improve public health through the development of therapeutics for all populations,” said Michellene Davis, Esq., President and CEO of NMF. “To truly bring about the change we want and need, we must accept the clarion call to eliminate systemic and structural racism that contribute to racial disparities in healthcare. ​NMF is proud to serve as implementation partner and one of the curriculum partners in this transformative initiative, contributing substantially to its concept, design, development, and management. Community-oriented, equity-minded health professionals are needed more than ever to address the historical causes of mistrust in healthcare systems and increase the engagement and participation of underserved populations.”

The multi-dimensional program is uniquely designed to foster clinical and translational research that is community-informed, designed and conducted. Participants receive training in evidence-based methods of community outreach and engagement. They participate in a multi-level mentorship model with established community-based Principal Investigators and with medical students through a major component of the program called the Clinical Investigator Pipeline Program (CIPP). The CIPP is an intensive summer service-learning externship that exposes promising rising second year medical students who are underrepresented in medicine to the basics of clinical trials and to working in underserved community health settings to provide outreach, education and engagement on clinical trials.

“Many aspects of the Bristol Myers Squibb Foundation Diversity in Clinical Trials Career Development Program make it unique,” said Eliseo J. Pérez-Stable, M.D., Director of the National Institute on Minority Health and Health Disparities, National Institutes of Health. “Its focus on helping clinical trialists become experienced in community engagement research methods is key to developing the trust necessary to realize an increase in clinical trial participation by people of color, yet we have not seen this in any other program of this kind. The program is also designed for long-term impact — engaging both practicing clinical trial physicians and diverse medical students, developing mentoring relationships that will build a pipeline of clinicians that are skilled in clinical trial diversity. All of these elements are rarely found.”

John Damonti, president, Bristol Myers Squibb Foundation, said that the response to the BMSF DCTCDP has been overwhelming. “The number of applicants exceeded our expectations, as did the stellar credentials of the physicians who applied. In fact, we expanded the cohort to include as many of these exceptional candidates as possible.” He added that the BMSF DCTCDP is a significant priority for the Foundation, which has been working for decades to improve health equity in the United States and around the world. “I could not be more pleased that we are realizing our vision for this program.”

“We are thrilled to contribute in a major way to this extraordinary program,” said Margaret Foti, PhD, MD (hc), Chief Executive Officer of the AACR. “This educational workshop will provide these early-career physicians with the remarkable opportunity to interact with and be mentored by leading clinical investigators, as well as leading biostatisticians and community engagement experts to learn the principles of excellent clinical trial design, and to develop the skill sets needed for building community networks. This program, along with the long-term mentorship offered to the participants, will prepare them to become independent clinical trialists and have the overarching benefit of advancing diversity, equity, and inclusion.”

The first cohort of scholars will begin their two-year participation in October 2021 with a program orientation, followed in early November by a six-day intensive educational workshop on clinical research, called BMSF-AACR Design and Implementation of Clinical Trials Workshop.

Applications for Future Participants – Cohort II Physicians and Cohort I Medical Students

Letters of intent are being accepted now through January 14, 2022 for the second cohort of clinical trial physicians. For medical students, the application period for the CIPP will open on November 15, 2021, and close on January 28, 2022. Interested applicants can learn more and apply by visiting the program website at www.diversityinclinicaltrials.org.

About the Bristol Myers Squibb Foundation

The Bristol Myers Squibb Foundation, an independent charitable organization, focuses on communities most at risk of suffering the impacts of serious diseases in regions of the world that are hardest hit. It empowers partners to develop and test innovative solutions to advance health equity and improve access to quality healthcare for patients. Grant making focuses on cancer, cardiovascular disease, and immunologic disease, as well as clinical trial diversity in the United States, and prevalent cancers in nine African countries, Brazil and China. The mission of the Bristol Myers Squibb Foundation is to promote health equity and improve the health outcomes of populations disproportionately affected by serious diseases by strengthening healthcare worker capacity, integrating medical care and community-based supportive services and mobilizing communities in the fight against disease. For more information, visit Bristol Myers Squibb Foundation (bms.com).

About National Medical Fellowships

Seeking to empower and support aspiring physicians and health professionals underrepresented in medicine to contribute to the health of our nation, National Medical Fellowships’ mission is to provide scholarships and support for students underrepresented in medicine and the health professions.

Founded in 1946, NMF is one of America’s first diversity organizations. Today, as the only national organization solely dedicated to providing scholarships to medical and health professions students in all groups underrepresented in healthcare, NMF is reducing healthcare disparities by creating new generations of clinicians and healthcare leaders who are dedicated to realizing health equity.

NMF is supported by a national network of more than 32,000 Alumni who serve tens of millions of patients annually. Together we continue to move health equity forward as we build the next generation of diverse healthcare leaders.

About the American Association for Cancer Research

Founded in 1907, the American Association for Cancer Research (AACR) is the world’s first and largest professional organization dedicated to advancing cancer research and its mission to prevent and cure cancer. AACR membership includes 49,000 laboratory, translational, and clinical researchers; population scientists; other health care professionals; and patient advocates residing in 128 countries.

The AACR marshals the full spectrum of expertise of the cancer community to accelerate progress in the prevention, diagnosis, and treatment of cancer by annually convening more than 30 conferences and educational workshops—the largest of which is the AACR Annual Meeting, with more than 74,000 attendees for the 2020 virtual meetings and more than 22,500 attendees for past in-person meetings. In addition, the AACR publishes nine prestigious, peer-reviewed scientific journals and a magazine for cancer survivors, patients, and their caregivers.

The AACR funds meritorious research directly as well as in cooperation with numerous cancer organizations. As the Scientific Partner of Stand Up To Cancer, the AACR provides expert peer review, grants administration, and scientific oversight of team science and individual investigator grants in cancer research that have the potential for near-term patient benefit. The AACR actively communicates with legislators and other policymakers about the value of cancer research and related biomedical science in saving lives from cancer. For more information about the AACR, visit www.AACR.org.

Footnote

1. https://www.fda.gov/media/143592/download

About Bristol Myers Squibb Company

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop, and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook, and Instagram.

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