Clinical trials often fail, and even those that are completed successfully may be failing us. Despite remarkable discoveries and breakthroughs in medical science, our research system – a necessity in determining safety and efficacy in the development of novel therapies – is not realizing all of its considerable potential. But we are at a moment of great opportunity in the evolution of clinical trials, and there is hope that major improvements are both possible and at hand.
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.
