Before COVID-19, clinical research was a little-known part of health care. Despite this process being responsible for determining the safety and efficacy of all the drugs, medical devices, vaccines, and other medical therapies available, less than 5 percent of the U.S. population actually participates in clinical research.
One reason why clinical research has little awareness and even lower participation is that, unlike other major industries, the pharmaceutical industry and many regulatory bodies never fully embraced technology to reduce the burdens of participation. We use our mobile devices to do our banking and place retail orders. Why can’t we use similar technology in clinical research?
Most clinical trials still require in-person doctor visits at large hospitals or academic institutions – some visits lasting several hours, sometimes multiple times a week. When you stop to think about the burdens placed on the average person – time constraints, travel requirements, childcare, and work demands, and financial commitments – it is easy to understand why more than 80 percent of clinical trials in the U.S. fail to meet their patient enrollment timelines and 30 percent of patients drop out. Right now, it’s just too difficult for trial volunteers to participate in clinical research.
Then that mysterious respiratory illness appeared in 2020, causing non-essential activities, like in-person visits for clinical trials, to come to a screeching halt. Out of necessity, researchers were forced to use creative, remote approaches to continue their existing clinical trials and follow up with their trial volunteers. Now, more than a year into the pandemic and with COVID-19 vaccine and therapeutic studies taking center stage, clinical trials have become part of our common lexicon, bringing much-needed awareness about clinical trials to the mainstream. COVID-19 jumpstarted the industry’s desire to make clinical trials a care option for all and health care delivery accessible to people from their homes, on their own time, and through their personal devices.
One newer approach that has gotten some momentum in the last year is decentralized clinical trials. Decentralized clinical trials use telehealth, connected devices, mobile apps, and other technologies to reduce the burdens and enable volunteers to participate in clinical research from anywhere and at any time. Decentralized clinical trials also can take advantage of community resources around trial volunteers to make their neighborhood the center of research rather than only at a traditional clinical site. By mailing the investigative drug to community pharmacies, drawing blood samples at local laboratories, or performing medical imaging scans at outpatient radiology offices, the need for volunteers to make in-person visits to meet with clinical trial investigators can be significantly reduced or, in some cases, eliminated.
In addition, tools like remote patient monitoring and telehealth for standard medical care enable patients to engage with their physicians from their homes. By using internet-connected medical devices, such as fitness trackers, blood pressure cuffs, and glucometers, patients’ vitals can be monitored in near real-time and their data accessible by their physicians. Then, if needed, patients can participate in follow-up video conferences with their physician or be referred for an in-person visit. This continuous monitoring and access to physicians is an important way to ensure patients’ wellbeing and spot serious health issues before they lead to a dangerous situation requiring hospitalization. This model proved exceptionally important during the height of the pandemic as patients with chronic conditions could limit their exposure to COVID-19 by staying at home for telehealth visits.
There are valid questions about the continued use of decentralized clinical trials and remote health care offerings after the pandemic. Certainly, technology is not a one-size-fits-all solution to the challenges in health care. The reality is that some diseases, conditions, and procedures will continue to require in-person visits and care. Also, some patients may simply prefer to have their visits in-person. Technology, however, gives patients the option to choose and can break down some of the inherent barriers to widespread health care access.
Fortunately for patients, it’s nearly impossible to return to what was business as usual. If clinical research is intended to represent patients more equitably and health care is to be more accessible, the process must be easier for the general public to participate. Technology is the pathway to make it happen. This is what I believe is good science – where anyone can access clinical research as a care option, not just a select group, and all patients can easily reach quality health care. Our responsibility as health care professionals is to create and develop the model that guarantees this access for all the patients we serve.
Kent Thoelke is a science executive.
Image credit: Shutterstock.com
