Over the past few weeks, I have found myself, along with many others, wondering and wishing for a time when things will be “back to normal.” We have all missed doing things that prior to mid-March, seemed normal; getting together with friends, attending sporting events or concerts, having dinner or drinks at our favorite restaurant or bar. Our industry has seen significant changes as well. We are no longer traveling to meet with clients and onsite monitoring visits have stopped. Additionally, many clinical sites and studies have suspended patient visits for ongoing trials, postponed recruitment of new participants into existing studies, and delayed the start of new trials. This delay in ongoing research will certainly have an impact on our ability to continuously improve on patient care and is one of a long list of indirect consequences of this global pandemic.
It’s hard to think about anything positive coming out of the COVID-19 crisis but perhaps we can use this as an opportunity think outside the box and accelerate evidence-based operations such that when things do return to normal, “the normal” will include new, more efficient ways of managing clinical trials. The past month has led many study sponsors, CROs, and clinical sites to come up with creative solutions to take the place of on-site monitoring visits. Several companies are leveraging technology to enable remote review of patient data and web-based source data verification of critical study entry and endpoint criteria. Clinical sites are making use of telemedicine to try to continue to follow study patients. Ethics committees and IRBs are being responsive to the need for new and unique means of ensuring patient safety and allowing for modifications to study procedures that previously would have required lengthy reviews. The world’s leading regulatory agencies have all issued guidance documents and are updating and revising those in close to real time. Work that historically has taken a considerable investment of time, effort, money, and in some cases, bureaucracy is moving quicker, simply because it has to.
Perhaps moving everything back to “normal” shouldn’t be our goal. My hope is that the Clinical Trials Community will build on the changes and forced innovation that is happening now to emerge from COVID-19 with a new blueprint for what is possible. Carefully reviewing and assessing the impact of less frequent on-site monitoring, or predominantly remote monitoring on the quality of trial data, could lead to dramatic reductions in the cost of operationalizing studies. Working to reduce the burden on study sites through centralized patient follow-up can act as a means of triaging, allowing clinical investigators and coordinators to focus on those patients with safety concerns/study endpoints and the recruitment of new participants. Discovering ways to better engage and collaborate with ethics boards and regulatory agencies could lead to fewer issues and greater alignment in expectations throughout studies. Once the Clinical Community has time to catch our breath, let’s take the opportunity to sit down, reflect on this time, and move our industry “ahead to better” as opposed to “back to normal.”
Craig Reist, PhD
Vice President and Chief Scientific Officer