As many of us continue to adapt to a world that is dramatically different than it was just a few months ago, we are also seeing the profound impact that COVID-19 is having on clinical trials. From how we structure clinical trial data to how we conduct the trials to the patient experience – we are all experiencing a greater need to accommodate new circumstances in uncharted territory.
On March 18, 2020, the US FDA issued, “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards”. The guidance was designed to “assist sponsors in assuring the safety of trial participants, maintaining compliance with good clinical practice (GCP), and minimizing risks to trial integrity for the duration of the COVID-19 public health emergency.”[1]
Since March 25, 2020, the US FDA has released 16 guidances that span CDER, CBER, CDRH, CFSAN, and CVM. On this date, the agency announced that due to the public health emergency, they would issue COVID-19 related guidance documents for immediate implementation without prior public comment. However, the guidances remain subject to public comment according to the agency’s good guidance practices. In the same announcement, they also committed to periodically publishing a consolidated NOA (Notice of Availability) of all COVID-19 related guidance documents issued during a relevant period rather than publishing an NOA for each individual guidance.
Approximately 1450 COVID-19 related trials are currently listed on clinicaltrials.gov and over 30 are federally funded through the NIH. The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, has developed a new strategic plan to accelerate COVID-19 research. The plan prioritizes characterizing the virus and developing diagnostics, potential treatments and effective vaccines.
Industry stakeholders have responded in similar fashion, accelerating important initiatives to support COVID-19 trials. CDISC launched a task force to develop an Interim User Guide for standardizing COVID-19 data. The task force includes members from industry, the US FDA, WHO, NIH and academia. The current version of the guide is available on the CDISC website so researchers around the world can take advantage of it in COVID-19 related clinical research.
While many clinical trials are being paused due to safety concerns, others are delayed because of the shifting priority to contribute to COVID-19 research efforts. Still other trials are moving forward with new challenges. Global supply chains for investigational drugs have potentially been interrupted. Patient enrollment and activation of new sites have slowed as medical facilities deal with the pandemic. Some site staff may be temporarily transferred to other duties in beleaguered hospital and medical systems.
The entire patient experience has also changed. Social distancing measures and telemedicine have reshaped patient visits. Concerns about continuity of care start to rise as some patients begin to show symptoms of COVID-19 and must self-isolate or are actually diagnosed with the virus.
As we look across clinical research, we can see how COVID-19 has touched various stakeholders. We can also see a rising need for flexibility to address new and unprecedented situations at various points throughout a clinical trial.
We recognize the potential for the role of technology to expand as research teams use artificial intelligence, machine learning and other emerging technologies to address these new and emerging challenges. The industry was already exploring many of these concepts to address evolving study designs, requirements and emerging science. If there is a silver lining of the current situation, it may be the acceleration of evolution and innovation in the industry.
At Mednet, our product strategy prioritizes flexibility throughout the clinical trial process. We could never have predicted the need to adapt to COVID-19 and the “new normal”. However, our vast and varied clinical trial experience has confirmed – and reinforced – our commitment to maintaining a high degree of flexibility across our platform. Now, more than ever, this requirement will continue to grow as clinical research teams wrestle with the ongoing impacts of COVID-19 and the demands of the future. And while the current environment creates significant challenges, it also presents great opportunity – for the industry to adapt and evolve rapidly.
[1] FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency, Guidance for Industry, Investigators, and Institutional Review Boards , dated March 18, 2020, Updated May 11, 2020, USFDA