Trends: What We Are Watching in 2021

We know we are not alone when we say we are happy to put 2020 behind us. It was a challenging year for everyone, and we look forward to better days ahead. Despite the difficulties that the research community faced, we witnessed remarkable flexibility, resilience and creativity in dealing with significant hurdles. Last year lent new meaning to the phrase “hindsight is 2020.” In this article, we look ahead at 2021 and share the issues that we will be monitoring.

Diversity and inclusion in clinical trials

The COVID-19 pandemic highlighted serious racial and economic disparities in health care.[1] Some racial and ethnic minority groups have been disproportionately affected by COVID-19. Conditions in the places where people live, learn, work, play, and worship affect a wide range of health risks and outcomes, such as COVID-19 infection, severe illness, and death. Long-standing inequities in social determinants of health that affect these groups, such as poverty and healthcare access, are interrelated and influence a wide range of health and quality-of-life risks and outcomes.

Likewise, racial and ethnic minorities are underrepresented in clinical trials. The research community, which includes industry sponsors and government agencies, is actively pursuing strategies that address disparities in clinical research. The FDA issued guidance in November aimed at enhancing diversity and encouraging inclusivity in medical research, specifically in the development of medical products. The industry trade group PhRMA adopted Principle 6, Commitment to Enhancing Diversity in Clinical Trial Participation, aimed at enhancing racial and ethnic diversity among clinical trial participants, with an effective date of April 14, 2021.

We will be watching how industry-sponsored and investigator-initiated trials implement strategies for increased inclusion.

Re-starting Clinical Trials

The pandemic led to the halting of hundreds of clinical trials[2]. Lockdowns and other mandatory public health orders forced research staff to work from home and made in-person patient visits nearly impossible. Additionally, staff resources were redeployed to shore up shortages and support hospitals’ responses to the surge in COVID-19 cases in communities in the U.S. and around the world.

For some patients, particularly with end stage disease, the suspension of clinical trials had serious implications. Likewise, enrollment for new trials staggered as patients were wary of visiting any medical facilities. In an editorial in JAMA[3], researchers said “Mitigation efforts [against COVID-19] interfere with all aspects of a successful clinical trial: efficient accrual and randomization, intervention adherence and delivery, and outcome collection.”

Even now, research institutions are grappling with solutions to reduce the impact of fluctuating and shifting public health mandates on existing trials. Investigators continue to evaluate how to re-start trials safely.

Increase in Observational Trials

Investigators have immense opportunities to design and implement investigational trials evaluating patient outcomes and long-term effects of COVID, as well as different treatment modalities. Additionally, researchers may consider trials evaluating various aspects of the different COVID vaccines currently on the market as well as other that are in the development and approval pipeline.

Opportunities for social-behavioral-education research

Stay-at-home orders and increased isolation, negative impacts on the economy and lost jobs, not to mention a daily barrage of dramatic news and social media coverage, have led to an increase in stress and anxiety. The pandemic also led to a disruption in mental health services.

We are still learning what the long term social and behavioral impacts will be. But we expect to see an increase in studies to evaluate this.

Remote Monitoring and Decentralized Clinical Trials

Since the pandemic began, over half of all active clinical trials are using remote and virtual support, according to a study by The Tufts Center for the Study of Drug Development.[4] We expect to see the continued use of telemedicine, remote monitoring and virtual IRB meetings and reviews.

Research professionals will continue to make adjustments to how they run research programs. Many institutions may need to make policy decisions in the absence of specific regulatory guidance.

In September 2018, the Clinical Trials Transformation Initiative defined decentralized clinical trials (DCTs) as those executed through telemedicine and mobile/local healthcare providers (HCPs), using procedures that vary from the traditional clinical trial model. For example, the investigational medical product is shipped directly to the trial participant).

The research community may need to continue to develop awareness and understanding about DCTs and/or hybrid trial designs, and what is in the best interest of patient safety as well as research integrity.

Using Digital Technology and Telemedicine in Clinical Trials

The trend toward digital technology, such as health tracking devices and virtual clinic visits, had started before COVID. The pandemic accelerated the implementation of these technologies to allow study participants to sign consents, submit vital statistics and data, and communicate with clinical research coordinators and investigators — all from the convenience of their home.

We are loath to make any predictions in this most unpredictable time. The story of COVID and its impact on research is still unfolding. With that, we plan to continue monitoring these issues and offering support to clients that are navigating these uncharted circumstances.

Happy new year from the team at BRANY.