In 2021, the sweeping race to develop and distribute a COVID-19 vaccine shed a light on the way the pharmaceutical industry has historically executed clinical trials. The current climate, afflicted by the pandemic, pushed large pharma companies to re-evaluate their approach to trials. Companies developing the COVID vaccines put an emphasis on diversity in trials and increased awareness of how different illnesses affect individuals of all races.
Statistics from a panel discussion at the BIO conference in 2019 revealed that racial and ethnic minorities make up 39% of the U.S. population, but rates of clinical trial population for this group range from 2% to 16%. Over the course of the year, it became clear that large companies were striving to close that gap and pioneer a future where inclusivity and diversity are prioritized in trials.
In further efforts to promote inclusivity in clinical trials, more trends emerged as players in the industry embraced the developments of new technologies. At the end of 2021, it was evident that the pharmaceutical industry had incorporated more innovative and efficient practices alongside diversity in trials, including: artificial intelligence, precision medicine, virtual reality, decentralized clinical trials, and new FDA and Advocacy standards.
Artificial Intelligence
In 2021, pharmaceutical companies around the world, including Roche, Pfizer, and AstraZeneca, began to incorporate Artificial Intelligence (AI) into their clinical trials. AI healthcare is accelerating productivity in the clinical trial industry with the personalization of care, identification of diagnoses, and the design of treatment plans.
Sujay Jadhav, CEO of Verana Health, explained in a statement the ways in which the pharmaceutical industry will benefit from advances in artificial intelligence. “Using natural language processing to make sense of the free-form text and derive meaningful insights from millions of doctors’ notes will allow life sciences companies to advance research and develop more targeted and effective therapies for patients.”
Reports show over 60 percent of healthcare organizations are interested in investing in AI in the near future, suggesting a major shift in the medical research field. Given their potential to improve the efficacy of clinical trials, optimize innovation, and accelerate the discovery and development of new drugs in the pharma industry, the utilization of artificial intelligence technologies is promising for the future of clinical trials.
Precision Medicine
Alongside the deeper understanding of the variations in medical needs amongst different demographics, came a rise in the use of precision medicine. This approach aims to provide personalized therapy to patients, weighing the variables of the patient’s genes, environment, and lifestyle. With this targeted approach, doctors can accurately provide the best course of treatment. While precision medicine isn’t a form of treatment that is personally created for the individual, it enhances the efficiency of a treatment for particular groups with similar genetic and molecular profiling.
This will revitalize how certain medical practices and treatment are conducted. Clovis Oncology, for example, is researching how precision medicine can target different subsets of cancer. By advancing scientific development, Clovis is strategizing how therapies can benefit the patient, and ensure they are getting the right drug(s) for their cancer.
Programs that fund precision medicine are underway, like the All of Us program by the National Institute of Health. This aims to deliver precision medicine by taking into account individual differences in lifestyle, environment, and biology. The Skin Of Color Society, an initiative focused on dermatology diseases (such as acne, actinic keratosis, eczema, psoriasis), raises awareness for health issues specifically related to skin color. Their work promotes education in skin of color dermatology, in efforts to spread an understanding of diseases that occur more in pigmented skin and effectively treat and support people of color.
Adding Diversity to Coronavirus Vaccine Development
The data from the Center for Disease Control (CDC) shows that 62% of the United States population has been fully vaccinated against the CoronaVirus. Amongst those hesitant to accept the vaccine are Black Americans. Despite the disproportionately higher rates of infection, hospitalization, and mortality than White Americans, Black Americans were reportedly less willing to take the vaccine due to a lengthy history of the mistreatment of Black people in medicine.
This trend of mistreatment, paired with the historical exclusion of Black patients in trials, pushed pharmaceutical companies to place an emphasis on representation in COVID trials. In efforts to ensure their vaccine trial evaluated the safety of the vaccine for all demographics, Moderna amended their study protocol to define their aims to enroll, “a representative sample of participants from these minority populations and adjust site selection and enrollment accordingly.”
Continuing the trend, Janssen recently reported their successful efforts in recruiting diverse patient populations for the COVID vaccine. Jansen utilized a program focused on community engagement and awareness and took steps to ensure their trials were accessible for diverse populations. “Simple yet impactful decisions, such as making sure trial sites were located in accessible places within historically underserved communities, made a big difference in our ability to reach more participants.” said Janssen’s Staci Hargraves in a recent article highlighting Janssen’s diversity efforts. The steps these pharmaceutical companies took to produce diverse COVID vaccine trials point the future of clinical research towards the direction of progressive, crucial change.
Updated FDA Guidelines
Over the decades, the FDA has issued guidelines to enhance diversity in clinical trials by focusing on eligibility criteria, enrollment practices, and trial designs. This year, with the recent movement in the pharmacy industry towards inclusivity and diversity, the FDA established new guidelines to support treatment for patients of all backgrounds. The themes they have included in their practices include:
- Loosening restrictions on eligibility criteria
- Ensuring trial participation is less burdensome for patients (reducing study visit frequency, using digital health technology tools, working alongside mobile medical professionals, offering compensation for participation)
- Providing resources in multiple languages
Participating individuals and advocacy groups can do a great deal to help shape and set the research agenda while opening up a dialogue for underrepresented groups. While working with these communities, they can also be key players to help develop new methods of engaging participants in ongoing research.
Decentralized Clinical Trials
Since lockdown began in 2020, researchers have had to reinvent their approach to executing trials, specifically in developing efficient ways for patients to receive treatment from home. As the world remained in limbo this year with the rise and fall of COVID cases, vaccine availability, and restrictions, research facilities continued the shift towards Decentralized Clinical Trials (DCT). DCTs allow for medical care to take place inside the comfort of a patient's own home. This is done by bringing research materials (i.e. medication, digital symptom entry journal, etc.) directly to the patient, expanding opportunities to those who may not have access to on-site trials and recruiting more diverse participation.
Due to the sudden shift from in-person lifestyles to remote, hybrid trials have been increasingly utilized as a solution for easing the medical and pharmaceutical industries into Decentralization Clinical Trials. The development of DCTs has presented its own set of challenges including finding technology vendors, processing increased patient data, patient education, and technology failures. Hybrid clinical trials require in-person visits that are conducted with mobile clinicians in alternative trial sites, bridging the gap between completely remote and completely in-person trials and offering an efficient alternative to conducting medical research.
Looking Forward to 2022
The trends of 2021 project that the pharmaceutical industry will continue to pioneer technological advancements that improve the patient experience and promote more efficient clinical trials. These trends also highlight the importance of diversity in early trial periods as clinical research continues to prioritize inclusivity. The future is bright for clinical trials. A more innovative approach paired with a targeted push for community outreach to underrepresented communities can lead the way to widespread inclusivity and novel medications that are beneficial for everyone.