The onset of the COVID-19 pandemic has introduced a variety of challenges to “business as usual.” The virus and the ensuing risk of contagion have altered how people conduct their lives. From wearing masks to a new emphasis on virtual “everything,” the world has changed. Some of these realities are self-evident (e.g., masks), but not every consequence of the pandemic is obvious.
Clinical research is a perfect example. Studies are being adapted to continue their progress during the pandemic (Read: 6 Study Adaptations to Keep Studies Moving Despite COVID-19 Pandemic). Obviously, COVID-19 has meant that patients do not come in for as many site visits – if a touchpoint with an investigator can be remote, a test can be performed at home, or a lab collected locally, it should be. This idea makes sense conceptually, but there are challenges to research in the age of COVID that extend beyond study adaptions.
In our last article, When Will Patients Return? The COVID Impact, we looked at some of the steps research organizations are taking to adapt to a new normal and explored how enrolling patients in a COVID world is different. In this article, we are going to look at some of the deep-seated challenges to efficient research.
The Wild West of Technology
What happens when a new technology emerges? Competitors emerge, with everyone fighting for market share. Sometimes, this friction is short-lived. Consider mp3 players, for example. Apple wasn’t the first company to make a digital music product. The iPod didn’t debut until the end of 2001, but the device didn’t emerge as the market leader until 2003 with the development of the iTunes Store. Then, that all changed again in 2007 with the release of the iPhone. Most technology follows a similar course: development of a concept and several competitors emerge, then one takes the lead because of some “other” element. Clinical research is no different.
Right now, the technology around clinical study data is diverse. Stat News says that “Health tech is the modern equivalent of the wild west” because the technology employed and the data collected is inconsistent across platforms, at best. Some contract research organizations use digital pulse oximeters so subjects can collect data from home, while others rely on massive spreadsheets to keep track of everything. There are no common standards in place, and that’s a problem.
Studies are collecting a massive amount of data. That all has to be integrated in order to provide meaningful insights, but it also has to be uniform. Consolidating data from different sources that do not meet the same standard would be like comparing hematological lab results when different agents are used. You get a result, but you can’t use it any more than you could gather objective assessments of the weather and conclude whether the temperature was comfortable for everyone. Sure, you could get close, but this is clinical research, not horseshoes. Precision matters most.
Right now, even something as simple as heart rate or temperature monitoring is fraught with complications. Wearable technology often measures pulse in its own proprietary way, and the end results from one device may not be the same as another. Further, the data has to be in a format that places well with the other technology in the metaphorical sandbox.
Clinical Technology and COVID
As research organizations have worked to adapt their activities to transcend COVID restrictions, keep studies going, and keep subjects safe, they have grasped at different technological solutions for remote monitoring, data collection, and telehealth. Working across borders, platforms, and technological restrictions is challenging during the best of times, but when you are trying to conduct clinical research during a pandemic, the need for unified technology is even greater.
Sometimes these technologies sync, but not always and certainly not all to the same effect. While this fact has led some in the industry to call for greater collaboration, that could take years, and there are studies underway right now that are facing technology issues. At Pharm-Olam, we are committed to using best-in-class technologies as well as taking the time to ascertain which solution is best for each study. Our data management group has the local connections and therapeutic understanding to determine the best technology for every study.
CRITICAL TRIALS ARENA: Clinical trials disrupted due to Covid-19 slowly resume
NATURE: Covid-19 and Human Behavior
STAT NEWS: With Covid-19 halting clinical trials, wearables could be key — but data ‘wild west’ gets in the way
SURVIVOR NET: Nearly 40% of Cancer Clinical Trials Disrupted By COVID-19 Are Restarting; Guidance for Patients
WCG CLINICAL: Insights
XTALKS: Clinical Development in the COVID-19 Era: Trial Continuity and Restarting Quickly, Safely and Successfully