COVID-19 and Its Impact on the Future of Clinical Trials

“What was the address again?” 

In what became a ritual prior to any physician appointment, I would look up the office address, choose whether I should walk, take public transportation, or drive, determine the optimal route for the time of day, calculate how much time I would have to be away from work, and brace myself for the ensuing anxiety associated with an in-person visit. Then one day, I was asked, “Would you prefer an in-person or telehealth visit?” My first foray into telehealth.

Telehealth is an umbrella term for the use of technology to facilitate long-distance clinical care, education, and public health programs. The onset of the COVID-19 pandemic resulted in a drastic shift toward providing care through virtual and ambulatory settings, and beyond patient care, clinicians and researchers are increasingly adopting technology to conduct remote clinical trials. 

A recent study published in Nature Medicine epitomizes just how important technology can be in public health and clinical research. Over 2.6 million participants were recruited in four weeks across five countries. Instead of invasive, in-person testing for each participant, researchers used participant-reported symptoms along with information from a subset who had undergone COVID-19 testing. With these data, researchers were able to identify key symptoms that could predict a probable COVID-19 infection. Further, the data can be shared with other researchers, and the code for the application is publicly available.

Healthcare Experience 

There are numerous benefits to having research and clinical care on the participant or patient’s terms. For example, many trials for chronic, debilitating diseases put the burden on the research participant to come to an artificial environment for day-long study visits. Without easy access to the institution, many potential subjects were unable to participate, especially people from lower SES (socioeconomic status) who could benefit from receiving regular, expert clinical care as part of the study. Further, with the duration of the study visit, people who were still working and unable to take a full day off work regularly throughout the trial and have a study partner also come with them were unable to participate. By moving healthcare and research to the home, we can move towards health equity.

Conclusion

Despite barriers to internet and technology access, virtual trials can serve to improve access and representation in clinical research. Researching in the comfort of the participant’s home can help to reduce confounders such as the white coat effect and allow for more flexibility and organic research participation. Lastly, there are opportunities to enhance the use of technology in healthcare and research through virtual reality and medical-grade wearable devices. Current clinical trials are using tools such as the Apple Watch or Verily Study Watch, the Emerald device (a passive, home-based sensor), and wearable sensors like the mc10 nPoint to passively collect participant data. It is paramount that patients are at the center of innovation to transform healthcare of delivery. This is the future of telehealth and healthcare.

Dr. Monica Javidnia is a neuropharmacologist and Experimental Therapeutics in Neurological Disease Fellow at the University of Rochester Medical Center, New York. Her work focuses on pharmacological and non-pharmacological management of motor and non-motor symptoms of Parkinson’s disease, disease progression modeling, and patient outcomes. Connect with Dr. Javidnia on Twitter and LinkedIn.



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