“Hey, if anything else comes up, I want to participate.”
That’s a phrase you probably have rarely — or never — heard from a person participating in a clinical trial you’ve been involved with designing, managing, or maintaining.
Like every aspect of the drug development process, clinical trials are rife with proverbial potholes that can slowly chip away at your progress and delay your timeline. Thousands of dollars go into recruitment, engagement, and retention efforts, yet inevitably subjects still drop out. There’s a myriad of reasons why this happens and when, which is why every clinical trial professional is always seeking ways to alleviate this ongoing burden.
There’s no doubt the COVID-19 pandemic further exacerbated some of the challenges associated with clinical trials, but it did fast track the adoption of decentralized trials as well as some of the associated technologies that enabled subjects to more easily participate remotely. Take the consent process, for example. Traditionally, trial participants are presented with a paper-based informed consent form (ICF) that is long and complicated to read. Site personnel often need to allocate a considerable amount of time to review the intricacies of a study with the subject. “I spoke with a patient recently who had a rare disease and had been participating in clinical research since she was very young,” says Wes Fishburne, offering manager, IBM Clinical Development eConsent. “She had to travel far to trial sites and reconsent almost every time because the science would continually change — sometimes monthly. She noted that it would have been great if they could have taken care of the reconsenting at home or on the way instead of having to sit down each time and go through the laborious legal paperwork and reread everything to learn what was new. She wondered why they couldn’t have watched a video of a doctor explaining what was new each time, which sometimes was just one paragraph.”
Fishburne notes that with COVID-19, eConsent functionality went from being an optional add-on to a feature CROs and sponsors considered essential and that was, preferably, fully integrated with their CDMS/EDC system. The latter was important because anyone involved with a clinical trial —from data managers, to ClinOps staff, to CRAs, and research coordinators — was already burdened with a plethora of technology and systems. The last thing they wanted to do was to learn a new program with a new log-in and password. Also, with COVID trials especially, there came a greater need to reconsent patients as trial protocols were changing rapidly. So, a system that didn’t require additional complicated training and integration (or a wet signature) became the norm out of necessity.