Amid the ongoing Coronavirus pandemic, clinical trial sites are increasingly inaccessible for patients and site staff, and as regulators halt inspections, the pharma and biopharma industry faces numerous challenges to ensure patient safety, compliance, and data quality and integrity. As the industry attempts to maintain operations during this global pandemic, risk-based trial execution and data quality oversight software will play key role in remote and centralized site monitoring to help overcome some of the blanket travel bans that are impacting operations and managing clinical trials effectively.

Patrick Hughes, Chief Commercial Officer and Co-founder at CluePoints, discusses how the COVID-19 pandemic is impacting the conduct of clinical trials and how leveraging data may herald a long overdue paradigm shift in the industry. –KB

Contract Pharma: How is the COVID-19 pandemic impacting the conduct of clinical trials?

Patrick Hughes: Any sponsor with an ongoing trial is assessing how they are going to manage operational activities when the ‘normal’ conduct is simply not possible. Patients can’t get to site or are unwilling to do so and the same goes for CRAs and Monitors. The impact on the clinical trial industry is unprecedented and represents huge risk for all stakeholders running trials at the moment. Further, anyone looking to start a clinical trial right now is having to think again and we’ve already seen a number of significant players calling a halt to all new study starts. So the starting point to determine how to cope is to assess the risk on all studies that are currently in flight. This will help determine what the new trial management process is going to look like and, generally speaking, from what we have seen so far there is triage process that is focusing on trials with 6 months or unless until database lock. This Risk Assessment process is crucial and will determine the necessary steps to mitigate inherent risks that previously wouldn’t have been a factor.

CP: How have restrictions impacted monitoring efforts?

PH: Monitoring is one of the most impacted processes in the wake of COVID-19. There are still thousands of trials that rely on the ‘traditional’ process of on-site monitoring every 6-8 weeks and that operational practice has effectively all but disappeared overnight. Thankfully, there are all alternative approaches that are even more effective but require rapid change management to ensure they are operationalized immediately. These methodologies revolve around using proven analytics to interrogate the data centrally and drive a remote monitoring process that identifies the regions, sites and subjects that need the most support, when they need it. The process itself is not difficult but requires an immediate change in mindset to get the most out of the data that can paint a vivid picture about what is going on in the study.

CP: How can data be used to address some of the key challenges sponsors face?

PH: Data is knowledge and it is this knowledge about the study or programs of studies that make it effective to manage the study remotely. Sponsors and CROs previously had a choice and often that choice was to do tomorrow what we did yesterday because it was considered familiar and safe. This choice is simply now not available and the only approach that will work is to use the data to focus operational efforts on what matters most in the study. The good news is that this approach is also more effective and the forced changes are going to herald a paradigm shift in the industry that was long overdue. As a colleague of mine commented recently, “shouldn’t we have always been washing our hands”. Sponsors and CROs will look back on this disaster and realize that it has been the catalyst for huge change that will make us all better, stronger and more effective in future. Data lies at the heart of this change. We’ll see many more virtual trials, use of patient wearables will be more widely used and remote / central monitoring will become the norm. COVID-19 is a disaster but there will be improvements that will be made to our groaning and creaking industry as a result and that will be beneficial to all of us in the long run.
 

Patrick Hughes, Chief Commercial Officer and Co. Founder at CluePoints. Responsible for leading global sales, product, marketing, operational and technical teams throughout his career, Patrick is a Senior Executive with over eighteen years international commercial experience within life sciences, healthcare and telecommunications. In the past, Patrick consulted on corporate and commercial strategy for various life sciences companies and was responsible for successfully positioning ClinPhone as the leading Clinical Technology Organization during his 10-year tenure with the company.