Patient engagement and diversity in clinical trials

May 18, 2021
By Samit Hirawat, Executive Vice President, Chief Medical Officer, Global Drug Development
I

remember even from the early days as I was going through my fellowship for medical oncology, the frustration that came with having to inform a patient that we had exhausted all options to treat their cancer. I always wanted to do something different, something better, something more. That’s what drove me to go into clinical research and broader drug development. It’s also why I’m so passionate about patient engagement. 

What is patient engagement? 

For all the expertise researchers bring, there are things that can only be learned by listening to the patient. Hearing from patients about how they feel, what’s bothering them, what’s life-limiting for them, provides insights that can inform every step of the healthcare journey. 

Incorporating  the patient perspective into the development and commercialization of medicines has become increasingly important industry-wide and particularly at Bristol Myers Squibb. In the field of drug development, where I focus, the pursuit of patient engagement is clearly evident in the design of clinical trials and in a companywide commitment to improve the diversity of participants in those trials. 

Patient engagement in clinical trials 

Clinical trials are a critical part of bringing new medicines to patients. Through the data generated from clinical trials, we answer important scientific questions and gain a better understanding about the efficacy and safety of these investigational medicines and their potential as treatment options for patients. Participating in a clinical trial can also pose a burden on the patient and caregiver and thus, understanding the patient perspective is an important element in designing a clinical study for success. 

For the past year, Bristol Myers Squibb has worked closely with patient advocates through an initiative called Patient Expert Engagement Resource, or PEER, to more formally incorporate and amplify the voice of the patient at every stage, from drug discovery and development through product commercialization. Through PEER, we now engage patient advocates to give us input into clinical trial design, such as the inclusion/exclusion criteria for participation, the selection of study sites, and more. Indeed, all pivotal trial protocols must include expert patient advocate engagement prior to internal sign-off.

We’ve worked with patient advocates on clinical trial design for about a year now, and as I start to see the results of these studies I’m more convinced than ever that this is going to make a big difference for patients during the clinical trials and beyond.

Clinical trial diversity

A commitment to patient engagement is also evident in efforts Bristol Myers Squibb is making to increase the diversity of its clinical trials. 

The gender, age, race and ethnic origin of a patient can sometimes play a role in how a potential treatment may work in a patient, so it’s important to include diverse patient populations in clinical trials. Including diverse populations also ensures that the trial participants are truly representative of the patients who suffer from the condition under study.

The COVID-19 pandemic has put a magnifying glass on disparities that have long existed in healthcare, especially for those from underrepresented minority communities. The awareness has also highlighted how minorities are significantly underrepresented in clinical research. The U.S. Census shows the Black population represents about 13 percent of the population and Latinx communities represent about 18 percent. But data from the U.S. Food and Drug Administration (FDA) reveals that enrollment of these groups in clinical trials is less than five percent. We as an industry need to be better. 

Since joining Bristol Myers Squibb, I’ve been the executive sponsor of an R&D working group dedicated to increasing diversity in clinical trials. This group has made great progress, and we’re only at the beginning. There is tremendous opportunity to make a longer-term, sustainable impact by establishing clinical research sites in diverse communities and supporting ethnically diverse physician scientists to engage in clinical research.

In response to this need, Bristol Myers Squibb and the Bristol Myers Squibb Foundation are each committing $150 million to accelerate and expand health equity and diversity and inclusion efforts, including efforts to increase clinical trial diversity.  Over the next five years, we will further extend the reach of our trials into underserved patient communities and the Bristol Myers Squibb Foundation will train and develop 250 new racially and ethnically diverse clinical investigators that can enroll a diverse patient population in trials conducted across the industry.

We are all patients

Gathering insights from people affected by the diseases we are researching is key to Bristol Myers Squibb’s vision to transform patients’ lives through science. But the call to action for achieving this goes well beyond any one company’s capacity to make meaningful change. Efforts to improve the design and operation of clinical trials, as well as the diversity in those studies, promise broad societal benefits in terms of more effective medications that help patients live heathier, more productive lives. To complete this journey, we need everyone’s engagement – patients, caregivers, advocates, clinical trial investigators, regulators and the industry. 

The pandemic has brought these issues to light. During and in a post-pandemic era, it will take all of us working together to keep them at the forefront and deliver on the promise of transforming the lives of patients through science; this is just the beginning!