Clinical Trials Won’t Ever Be the Same & Why That’s a Good Thing

There’s always a silver lining if you look for it. While the COVID-19 pandemic created many challenges over the past 18 months, and many clinical trials themselves were paused for a time, we are seeing benefits from our forced new normal. As we approach one of the most anticipated oncology meetings of the year, we are grateful for the clinicians who pressed on with their research in the face of a global pandemic. From our own experience, we know it was nearly impossible to maintain external momentum at times, but we also know that there was a lot to learn to succeed while doing things differently. While COVID-19 changed much of what we did over the past year, there were some valuable lessons. The pandemic allowed us to identify areas where we could improve the diversity and inclusion in clinical trials and our industry collaboration.

Diversity and Inclusion

COVID-19 shined a spotlight on the need for diversity and inclusion in healthcare. The under-representation of racial and ethnic populations in clinical trials is a well-documented issue that affects studies around the world. Whether due to biology or circumstance, the pandemic’s impact was far greater on some races and ethnicities, forcing many to see the importance of fostering diversity in clinical trials. It is clear that the convergence of biologic and economic factors plays a critical role in access to health care. Seeking ways to ensure inclusion should focus on eliminating barriers to care and increasing access to clinical trials for those patients who are traditionally underserved or underrepresented is not only the “right” thing to do, it’s a “must”.

Academic institutions across the country want to increase diversity in their clinical trial population to look more like the people they serve. Yet progress is slow and the investigators are looking for answers. At a recent Radiology Grand Rounds at Montefiore/Einstein Medical Center in NY, the doctors asked what needs to change for ethnic patients to join clinical trials? One answer was trust. Patients need to trust the people running the trial as well as the agent being studied. The agent could be a small molecule, a biologic, a device or a procedure. Does the person running the trial look like I do or speak my language? Does the biotech company understand my needs? Does the study team have cultural competency? These questions provide a window into how companies can expand the catchment areas in clinical trials beyond the current pool of similar institutions with homogenous demographics.

As a healthcare community, we have a great responsibility to help ensure that our efforts are providing a positive impact for as many people as possible, and our leadership must set the example for other industries.

Within our industry, we need to apply strategic tactics that continue to encourage diversity in all aspects and stages of clinical research. This means partnering with healthcare providers who treat underserved and racial/ethnic populations to help recruit an array of patients for clinical trials and inform them of participation opportunities. We must also design inclusive clinical trials that represent the target populations affected by specific diseases. Companies should continue investing in community education, outreach and efforts that build trust within diverse communities to drive clinical trial awareness and participation, while incorporating the patient voice throughout the clinical trial process.

Central to building trust and moving the needle is partnering with community organizations and social groups. Fraternities, sororities, senior centers, civic organizations, religious institutions and most importantly, Community Health Centers are critical alliances for investigators when recruiting for clinical trials. They can help with translating and teaching cultural competency to the study team. Patients become more comfortable when they see trusted leadership and community sponsors partnering with the company and clinical trial team. As a result of these collaborations, a cross cultural team forms which is focused on the same goal: Health Equity for everyone. Dr. Augustus A. White III, a world leader in orthopedics and social justice at Harvard Medical School, reiterates this point in his lectures and publications. I am working closely with Dr. White and his team to establish an Institute focused on Health Equity inclusive of clinical research.

Industry Collaboration

The pandemic led to a shift from clinical trial competition to collaboration. The life sciences industry came together like never before; we were unified by a common goal of fighting the pandemic. Companies, academic institutions, and medical facilities shared critical data and information. We synergized with advocacy partners and medical colleagues to stay connected with patients to reassure them that our work toward treating other diseases was still a priority.

Now, we know the possibilities of collaboration. The new systems developed over the past year for sharing information, including new precedents in contracts between entities and a new speed of review at peer-review publications, can be used again to help us tackle other challenges together.

While competition will always exist, we now appreciate more than ever, the value of collaborating for a common goal of developing safe, effective medicines to treat people with serious diseases.

The pandemic is, of course, correlated with its devastating impact; but I try to focus on the silver lining. We now have a window into how we can better meet the needs of all patients, regardless of their background, ethnicity, or circumstance, as well as insights into better communication and coordination. Together, we can strive for a world where no one is forgotten, and good health is a part of everyday life- like the sunrise at the start of a new day.