At the start of COVID-19 pandemic in early 2020, scientists quickly pivoted to study this new disease’s transmission, clinical course, treatments, and identify prevention strategies. At the same time, the many social changes made in response to the pandemic such as restrictions on travel, and group activities and the need to work and attend school remotely, forced changes to the ways in which research was conducted. In this blog, we consider how these changes may have pushed research into adopting approaches that make it easier for participants (“participant-centered”).
To reduce potential transmission of the COVID-19 virus, human subjects research studies quickly implemented approaches to continue important research in ways that also protected research participants. Virtual methods to interact with participants became the norm and were even used for recruitment, enrollment and informed consent in human subjects research. Further boosting the use of virtual methods, the FDA published related guidance in March 2020 (updated August 2021).
Now, a little more than two years later, digital health technologies such as smartphones continue to be used for human subjects research-related tasks, e.g., sending reminders to participants and enabling the recording of health information. Wearable devices like fitness trackers, smartwatches, and sensors are used to generate data on physiological measures, such as heart rate, sleep, and glucose levels, all without the need for direct interaction with the research team. Clinical trials are moving away from traditional sites at large medical research institutions with in-person follow-up to trials that are either fully decentralized with trial activities from enrollment to monitoring conducted remotely or are hybrid with a combination of in-person and digital activities.
The increased use of electronic methods for human subjects research as well as for education, work, and other interpersonal interactions during this pandemic has increased awareness of “e-equity.” The past two years have seen a ramping up of efforts to increase access to the internet and electronic communication platforms, especially in rural and lower income areas, as well as wider distribution of associated hardware such as laptops, tablets, and mobile phones. However, some populations, such as the elderly, continue to be less likely to use electronic devices, even with improved access.
The racial and ethnic disparities in COVID-19 cases in the United States has also increased attention to the continued need for diversity in associated human subjects research studies. This, in turn, has led to more awareness and involvement of community groups in research recruitment efforts. We hope this will also continue to advance the trend of enabling affected communities not only to help recruit participants, but–equally important–to participate in formulating research questions to ensure that issues considered priorities by patients, such as quality of life and management of treatment side effects, are included in clinical research in addition to the more traditional focus on diagnosis and treatment. Also important is the growing recognition that diversity in human subjects research means inclusion not only of participants from racial and ethnic minority populations, but also improved representation of women, participants across the lifespan, individuals with physical and mental challenges, and those from different sexual orientation and gender identity and expression groups. Several excellent resources on diversity and inclusion in clinical research are listed in the Resources section below.
Finally, research studies must continue to document the impact of COVID-19 on outcomes in non-COVID research, such as possible changes in frequency and types of adverse events, as well as changes in subject lifestyle, i.e., remote work patterns, increased time on computer, decreased physical activity, and fewer social interactions.
Hopefully, in 2022, with continued uptake of vaccinations worldwide and other effective prevention and treatment strategies, the COVID-19 epidemic will move toward becoming an endemic or seasonal disease like influenza. But we hope that the changes that have made research more participant-friendly will continue as one positive outcome of the pandemic.
RESOURCES:
FDA Guidance: Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency; Guidance for Industry, Investigators, and Institutional Review Boards. March 2020 (updated August 2021).
FDA Guidance: Enhancing the Diversity of Clinical Trial Populations: Eligibility Criteria, Enrollment Practices, and Trial Designs; Guidance for Industry. November 2020
Clinical Trials Transformative Initiative: Increasing Diversity in Clinical Trials Project Report, July 23, 2020
Harvard’s Multi-regional Clinical Trials Center guidance “Achieving Diversity, Inclusion, and Equity in Clinical Research.”
WCG IRB, and WCG Alive White Paper: Making Clinical Research inclusive: Strategies to include the for LGBTQIA+ Community in Research Trials.
MD Newsline: Improving the Inclusion of Persons with Disabilities in Clinical Trials: What Can We Do? November 5, 2020.
