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What has changed in 2020? How will 2021 shape up? Let’s evaluate.
2020 felt like a decade. So much change has happened in our lives, both personal and career wise, and we have forced ourselves to push the boundaries to implement novel clinical operational methodologies and technologies at breakneck speed. In February 2020, when I was stranded in Madrid due to the COVID lockdown, I discussed available opportunities to decentralize trials and continue operations during the pandemic. Was my discussion spot on or way off? What has changed in 2020? How will 2021 shape up? Let’s evaluate that.
When most of the world shut down in Q1 2020, many clinical trials came to a grinding halt, study sites reprioritized their efforts towards essential tasks and shuttered their doors to on-site monitors, trial patients were missing study visits, and enrollment stopped. Clinical operations personnel were left to scramble in desperation to continue operating their trials and find patchwork solutions (offering transportation to subjects, demonstrating safety procedures around COVID, and continually engaging subjects) until FDA released a guidance document in March on operating studies during the COVID pandemic.
When I shared a video describing my thoughts on advancing decentralized clinical trial implementation and offering suggestions to the clinical research community, I hoped to garner comments and provoke discussions. Many colleagues in the clinical research community noticed and expressed what they were going through, to my surprise. Personnel who work in clinical innovation functions at big biopharmaceutical companies led the discussion and pushed towards implementing proven decentralization approaches. Other researchers indicated that there was much discussion amongst their colleagues to implement decentralized trial approaches.
It was clear: the decentralized clinical trial (DCT) approach was the most viable solution to continue operating clinical trials during the pandemic.
Many biopharmaceutical sponsors and study sites, large and small, rushed towards decentralization in light of FDA’s guidance. Sponsors reworked their clinical trial operations by creating new study site procedures (i.e., direction from IRBs, sending the investigational product to the patient’s homes, amending protocols, protocol deviation documentation practices, and safety reporting), trimmed their protocols to exclude unnecessary data, and brought on new technologies and services to support decentralized approaches, such as implementing home-health nursing visits and remote data capture technologies. The rush towards decentralized technologies is valid, as some decentralized clinical trial companies reported a more than 400% gain in revenue.
However, some industry segments were successful in implementing DCTs, whereas others were not. Big Pharma was at a significant advantage; the experience in running pilots, establishing internal technology transformation processes, and having the right culture drove efficient and effective DCT approaches and techniques. Some other biopharmaceutical enterprises were not so fortunate, as they have attempted to incorporate antiquated methodologies and processes in DCT design, which has led to subsequent quality issues.
As FDA warned in its guidance, clinical trial quality issues have likely arisen during the pandemic and have yet to be uncovered. Accordingly, clinical quality professionals have gone all hands-on deck to address clinical quality issues before they transpire into more significant problems. The biggest challenge during DCT implementation is that many sites have not had any experience with DCT approaches, and poorly designed DCT workflows have exposed study sites to compliance issues. Aside from the apparent remote site monitoring implementation, quality professionals focus on a solution that enables efficient virtual study quality assessments: the trial master file (TMF). TMF audit processes include key document reviews (KDRs) conducted regularly to ensure document completeness and structured approaches towards conducting inspections, such as TMF access management plans, storyboard templates, and appropriate training. TMF audits offer clues on study quality at sites, which inform more intensive audits. Sponsors are now formulating remote auditing procedures, including site preparation and training, audit communications, and technology setup. A focus on TMF quality and the conduct of remote audits seem to be what sites should expect soon to maintain quality oversight during the pandemic.
We will surely see a vaccine in 2021; nonetheless, experiencing a new “normal” will likely become a reality around 2024. Social distancing measures will still be in place for some time, governments will need to determine policies for vaccination validation, and COVID infection rates will need to be mostly eradicated before easing up COVID prevention measures. Additionally, people need time to get over the trauma of having dealt with a pandemic, and patients’ needs and expectations are changing drastically.
For clinical trials, 2021 will bring about a new norm for sponsors. Specifically, DCT approaches will likely be a part of every study’s design, and sponsors will have to deal with uncovering compliance issues and addressing them. 2020 has put us all through a journey; I’m optimistic 2021 will bring exciting opportunities for the clinical trials industry and the world as a whole.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.