One Size Does Not Fit All: The Future of Clinical Trials

Our new initiatives are increasing diversity of participants and investigators, expanding impact to more patients.

Sustainability|Jul.19, 2023

If there is one universal truth accepted by all who have reached the age of reason, it is this: One size does not fit all.

It’s as true in healthcare as it is with every individual.

Just like there is no single solution to a problem, nor one road to better health, there is no one way to improve people’s lives.

Because there is no one patient.

For years, optimizing medical progress and expanding its impact was slowed by conducting clinical trials confined largely to adult male, white volunteers.

This conflicted with the growing knowledge that gender, ethnicity and environmental/societal differences all play a factor in overall health.

Since diverse participants were not equally represented in clinical trials, this impacted the understanding of which therapies best helped whom.

As leaders in the study and development of new ways to reach out to – and better treat – under-represented populations, we have focused on building a foundation of trust and science. This emphasizes diversity and inclusion in clinical trials to develop solutions that most benefit the greatest number of people.

But the work is complex and far from complete.

Not as Simple as 1, 2, 3. Rather, Step by Step.

Which is why we’re introducing not one or two, but three new programs in our continuing multi-million dollar initiative to further increase diversity in clinical trials and improve care among under-represented groups.

It’s all part of our comprehensive 2030 sustainability goal of improving the lives of more than three billion people by decades end – reaching one billion more than we do today, each year. We can only do that by continuing to develop innovative medical technologies across multiple healthcare disciplines around the world, and that only occurs after successful, representative clinical trials.

Step1: Create a new Diversity in Research Office at Abbott to make sure that all our clinical trials have a variety of participants.

This group will be led by Jennifer Jones-McMeans, Ph.D., divisional vice president of global clinical affairs at Abbott’s vascular business and Aparna Ahuja, M.D., divisional vice president of medical, clinical and scientific affairs at Abbott’s rapid diagnostics business.

As well-established experts in the field, they will oversee our holistic efforts to not only improve diversity, equity and inclusion plans – which will establish a template for future trials – but also to set performance goals and help collaboration efforts across the company, industry and regulatory groups.

“We are committed to addressing as many barriers to participation as we can,” Jones-McMeans said. “We’ve implemented programs that will increase the diversity in our trials by increasing participation from under-served and under-represented populations.”

“Achieving greater diversity will continue to be a key focus throughout Abbott to facilitate development of appropriate diagnostics, products and treatment ensuring better ways to fight diseases that often disproportionately impact diverse populations," said Dr Ahuja.

Step 2: Fund a multi-year commitment to establish research program models at Historically Black Colleges and Universities (HBCUs).

One of the challenges of setting up sustainable research models serving diverse communities is getting the resources needed to design and develop them from scratch.

Which is why we are providing $1.5 million to the Institute for Health Equity at Norton Healthcare to build models for HBCUs and clinics serving under-represented communities.

In addition to this work that will serve as a roadmap of best practices, the five-year commitment will support the hiring and training of research coordinators, data managers and others to help launch and sustain valuable programs.

In fact, two new research center programs – one in rural Mississippi, associated with Morehouse University College of Medicine and the second located in Louisville, Kentucky – are set to launch in 2023. This, in turn, will increase the number and quality of research sites, further reducing barriers to clinical trials.

Step 3: Provide a comprehensive program to support training of diverse clinical research coordinators.

Partnering with Barnett International, we are developing an educational program for the instruction of new clinical research coordinators (CRCs), who act as a central point of contact for patients, families and investigating physicians leading clinical trials.

CRCs are vital to trial success. Through this training, we will empower them with a strong foundation in essential core areas of clinical research, including study execution, patient consent, good clinical practice guidelines, documentation and other regulatory considerations.

Expanding CRC training to those with diverse backgrounds is designed to reduce another possible barrier for potential study participants.

Long-term Benefits of Clinical Trial Diversity

Our diversity initiative is just one aspect of continuing efforts to enhance health equity, expand access and affordability, and remove barriers to life-improving technology and scientific innovation.

We are building on the foundation of our initial success in establishing a Diversity in Clinical Trials Medical Advisory Board. This organization is comprised of external experts and an internal steering committee, while also focusing on increasing diversity enrollment in our own clinical trials.

Through $5 million in grants, we’ve also sponsored more than 300 scholarships at four HBCU medical schools, the National Black Nurses Association and the National Association of Hispanic Nurses to support future leaders of clinical research.

Complex. But Necessary.

We all love patient stories like the 22 year old woman who is leading a healthier life because of her cardiac monitoring device, or the young black woman whose life was turned around by her cutting-edge glucose monitor, or the African-American man who was kept alive by his cardiac device until a healthy heart became available for transplant.

But each of these stories – and thousands more – are borne out of clinical trials that work best when they reflect the complex economic, cultural, scientific, medical reality of our ever-changing healthcare universe.

It’s a complex and often problematic world where one size most definitely does not fit all.

But we get that.

So, if you’re looking for us, we’ll be here in the background, trying to improve health outcomes by enhancing diversity in clinical trials, developing devices that fit each individual best, allowing them to live life to the fullest.