Going Digital: Clinical Research in Pandemic Times with Discussion

Posted by:  Katie Keenoy

Authors: Dr. Ginger Nicol, MD and Dr. Eric Lenze, MD

COVID-19 is an unprecedented challenge for clinical research

Most of us are scrambling to adhere to newly-released policies limiting “non-essential” face-to-face interactions, including those with our study participants. These are chaotic times. New rules and recommendations are changing at a moment’s notice. We must be proactive, adherent to the principles that serve our patients now, while preparing for future disruptions.

Moving research into the digital age

The new norm is “action at a distance.” Digital tools minimize face-to-face contact with vulnerable populations should be rapidly deployed to screen and consent participants, collect data, and intervene remotely. Click here to see an example of IRB language for shifting to e-consent.

Social distancing = social isolation

One of the most important contributors to all-cause mortality in older adults is social isolation. As well, prolonged exposure to an environment of uncertainty and fear has lasting negative effects on mental health across the lifespan, but perhaps most importantly in youth. In all cases, human connection is the antidote. It’s important to use the technological resources available to us to continue to foster social connection amid the necessary physical distancing.

 We are scientist-healers

Clinical researchers have an obligation to help, and we can! Individuals living with mental illness in particular are the most vulnerable to both the negative health and psychological effects of COVID-19. Highly developed clinical research infrastructure and skilled research staff are key to mobilizing innovative clinical research approaches for helping patients through this crisis.

 A new twist on community partnership in research

We also have an obligation to chronicle this extraordinary threat and its effects on our participants, while extending our reach into the communities in which we live and work. Supporting our participants and their healthcare providers is the right thing to do, and strengthens community partnerships to the benefit of future research efforts. Collecting qualitative data as we do so allows us to authentically tell our participants’ stories in a way that honors their contributions to science, while easing public health impact in a tangible way.

 From principles to practice: Recommendations during the COVID-19 outbreak

1. Implement technology now: Minimize face-to-face contact with participants by utilizing digital tools, such as shifting to electronic informed consent and digital HIPAA-compliant tools like emailed surveys or telehealth assessments. Click here for an example of electronic informed consent.
2. Assess the psychological and social impact of COVID-19: How are participants coping? What health & social behaviors have changed? How are they keeping up with current events? What are they doing to stay connected to their families, friends and communities? And most importantly, are their health care needs being met?
3. Mobilize research platforms for patient needs: Equip research staff with tangible resources, and provide timely population-specific health information to support patients and healthcare providers. Turn routine phone contacts for research assessments into opportunities for connection, problem-solving, treatment planning, and linkage to resources. Above all, continue working – to help as many people as possible through the crisis.

Research…with immediate impact

On average, it takes 17 years for results from clinical trial results to become common clinical practice. We have an opportunity to make an impact now, as this pandemic continues to unfold. We will continue to post information as we learn additional ways to keep our studies flourishing in these disruptive times.  In the meantime, we want to know how you and your team are managing this? Take a moment to tell us about your challenges and successes by commenting below. We can all learn from each other, in real time, how to keep our studies flourishing in these disruptive times.

References

1. Arean PA, Hallgren KA, Jordan JT, et al. The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. J Med Internet Res. 2016;18(12):e330.
2. Jeste DV, Lee EE, Cacioppo S. Battling the Modern Behavioral Epidemic of Loneliness: Suggestions for Research and Interventions. JAMA Psychiatry. 2020.
3. Steptoe A, Shankar A, Demakakos P, Wardle J. Social isolation, loneliness, and all-cause mortality in older men and women. Proc Natl Acad Sci U S A. 2013;110(15):5797-5801.
4. Sprang G, Silman M. Posttraumatic stress disorder in parents and youth after health-related disasters. Disaster Med Public Health Prep. 2013;7(1):105-110.
5. Brooks SK, Webster RK, Smith LE, et al. The psychological impact of quarantine and how to reduce it: rapid review of the evidence. Lancet. 2020.
6. U.S. Department of Health and Human Services OfHRPOFaDACfDEaRCOo. Use of Electronic Informed Consent Questions and Answers: Guidance for Institutional Review Boards, Investigators and Sponsors. December 2016.
7. Fineberg HV. Pandemic preparedness and response–lessons from the H1N1 influenza of 2009. N Engl J Med. 2014;370(14):1335-1342.

This is informal guidance that does not necessarily represent official university or federal policy.

Please share your thoughts, ideas, and experiences by commenting.