Is Your Clinical Trial Monitoring Plan Prepared for COVID-19?
The following blog highlights considerations for preparing your clinical trial monitoring plan for current COVID-19 restrictions.
As the biotech industry takes up the search for COVID-19 treatments and vaccines, all ongoing clinical trials must come to terms with new constraints imposed by the pandemic. Irrespective of indication, all studies face challenges as a result of the shifting safety measures aimed at containing the spread of the novel coronavirus and protecting patients and clinical sites. New guidance documents, such as those released by the FDA in the US, by EMA in Europe, and by the MHRA in the UK, provide guidelines for execution of clinical trials and suggestions for managing risk while maintaining the integrity of study data. Clinical monitoring becomes more crucial as protocols are adapted.
What’s your monitoring contingency plan?
How will clinical trial monitoring shift to adapt to the current environment, while at the same time preserving the integrity of ongoing studies? The team at Worldwide Clinical Trials has identified areas where the clinical trial monitoring function may be affected by COVID-19. Here are five ways we are pivoting to help our customers stay resilient in the face of disruption and keep them on track for trial success.
- Focus on Risk: The safety of subjects and data integrity are the primary focus and priority for our studies. A risk assessment is performed on all our studies in order to identify critical data and processes that affect these important components. The risk assessment is reviewed throughout the course of the trial. We are continually evaluating how those risks are affected by the COVID-19 pandemic, identifying new risks, and updating contingency plans to monitor effectively in the current landscape.
- Remote Monitoring: When sites have suspended or restricted on-site monitors, Worldwide has shifted to remote monitoring strategies. In line with regulatory guidance, remote monitoring/site management strategies use a variety of off-site monitoring techniques, such as off-site review of redacted records and use of electronic medical records (EMR). As sites allow on-site visits, we have shifted resources, where possible, to reduce travel or limit it to local travel and partner with sponsor and individual sites to accommodate monitoring restrictions. The combination of remote and on-site monitoring strategies has enabled us to continue to meet sponsor timelines while ensuring sites are healthy and profitable.
- Technology: As the need for paperless trials has risen, the use of technology during this pandemic has become even more critical for clinical trials. From payment solutions to patient and site recruitment retention, e-consenting, off-site remote monitoring, centralized monitoring, study supplies, electronic trial master file and investigator site files to electronic data capture and direct data entry, we at Worldwide have strategies and technology available that help reduce, and in some cases eliminate, paper documentation to ensure an efficient and reliable trial. Keeping regulatory guidance in mind, our goal is and continues to be to simplify the technology support for our sites, sponsors, and monitors.
- Geographic Considerations: Global studies have varying site impact because pandemic conditions vary from region to region and local containment responses differ accordingly. Thus, monitoring processes are adapted according to guidelines from local and regional authorities in each country where the trial has active sites.
- Investigative Sites and Research Staff: Because patient safety is a top priority, it is important to partner with our sites and optimize their time, focus, and effort on their patients. When we are looking at our monitoring strategies, we must balance oversight with compassion and always keep in mind the human component of our trials and the dedicated staff working alongside the patients. They may be undergoing additional challenges, including working from home (shelter-in-place orders) or having their children at home due to school closures, etc. We can’t forget the human element. While we are trying to collect data and continue the monitoring process, we keep these additional challenges in mind. We must ensure that we are only requesting critical information important to the sponsor and trial while continuing to build strong working relationship with our investigative sites.
Clinical Trial Readiness
The pandemic has altered life as we know it, and the work of clinical trials is no exception. Clinical trials require a deft hand in execution, and stakeholders must be able to keep their footing as we make our way through this shifting landscape. Success hinges on the ability to focus on risk, shift to remote monitoring strategies, leverage technology to support data collection, adapt to geographic considerations, and balance the needs of investigative sites and research staff. It’s a tall order.