Clinical Study Reports for Studies Impacted by COVID-19: Key Considerations

Like many features of our personal and professional lives, the COVID-19 pandemic has had a significant impact on clinical research, especially on active treatment studies. From increased difficulty enrolling participants in studies and collecting measurements to reduced availability of supplies and potential new biases in the data, clinical research is grappling with major changes and challenges, all while trying to ensure that data and scientific integrity are upheld.

In this daunting environment, the pharmaceutical industry is banding together to support study participants, clinical researchers, and research sponsors. For example, industry regulators like the Food and Drug Administration have released guidance for researchers, focused on the health and safety of clinical trial participants. 

Here at TransCelerate, our Clinical Content and Reuse (CC&R) initiative created a new team focused on identifying how clinical study reports can be adapted to reflect any disruption that may have occurred due to COVID-19. 

TransCelerate’s impressive global network empowered the CC&R team to quickly assemble a group of over 50 experts from the member companies within TransCelerate to consider and identify the most important considerations for clinical researchers and research sponsors related to writing clinical study reports for studies that have been impacted by COVID-19. The CC&R team is well-positioned to support clinical researchers and research sponsors as the team is highly familiar with regulatory guidance on clinical study reports and they update the tools and templates annually. The core team already has strong relationships with global pharmaceutical regulators and other industry consortia, allowing for rapid adjustment and feedback on the process and the findings. Finally, the expert team was diverse, featuring medical writers, statisticians, data scientists, safety experts and more from 10 countries and 15 TransCelerate Member Companies. 

Assessing CSR COVID-10 implications

The CC&R team identified considerations in a few domains that clinical researchers and research sponsors could consider as they write their clinical study reports for trials that may have been impacted by COVID-19. To name just a few, researchers should start by identifying and explaining if and how COVID-19 impacted their trial, including any deviations in protocol. Researchers and sponsors could also consider how the pandemic may have impacted their trial data. For example, the pandemic may have been in different stages at different study sites, the site(s) could be closed temporarily due to COVID-19, or some participants may have been at greater risk of contracting COVID-19 and/or were not willing to travel to the site.

Not all considerations will apply to all trials: while some trials may have failed due to the COVID-19 disruption, others may have been impacted only minimally. The circumstances of each trial must be evaluated by the sponsor to determine the extent of required reporting.  

The end result is the CSR Considerations for Studies Disrupted by the COVID-19 Pandemic, which shares several important lessons related to managing the execution of clinical trial logistics while prioritizing participant safety. This tool is intended to assist sponsors as they plan for Clinical Study Report (CSR) documentation of the effect of the COVID-19 pandemic on a clinical trial. This document provides prompts for consideration but should not be treated as a checklist or set of minimum requirements for reporting. This document is intended to be used as a starting point and discussion of trial-specific situations or nuances may be appropriate as they arise. 

Beyond the considerations and sample text that the team produced, another impressive outcome of the CC&R CSR team’s work is the rapid turnaround of the project. The team produced the initial key considerations in just a few weeks. This speedy output was enabled by the team’s existing familiarity with remote work, making virtual conferencing easy to adopt. The team also took a sprint-based approach to deliver the work, using short focused bursts, breaking the document into smaller sections, and implementing a culture of accountability to make sure that everyone contributed as agreed. As many of us have adapted to a “new normal” of remote work, the existing remote ways of working among TransCelerate teams served the CSR team well. 

How COVID-19 may impact future research

Clinical research and the writing of clinical study reports may change permanently due to COVID-19. For example, I anticipate that trials will become increasingly decentralized and/or virtual, incorporating remote monitoring, home visits and telemedicine into the process. The CC&R team is also looking forward to broader use of tools like the TransCelerate templates, eSource and other source data verification to promote high quality clinical trials in all settings. The impressive effort by the TransCelerate CC&R team to quickly deliver an impactful set of considerations and sample text to the pharmaceutical industry is a reminder of the power of the TransCelerate network, our experts and member companies. As clinical research moves forward post COVID-19, we look forward to the opportunity to continue to work with our members and the broader pharmaceutical and research communities to ensure that change is for the better.

A message from the author Elizabeth Bygate:

I have recently retired from GSK after over 30 years of experience within Research and Development primarily in Clinical Pharmacology Operations. I also spent two years as the TransCelerate Program Lead within GSK. From its inception in 2014 until June 2020, I was leader of the Transcelerate Common Protocol Template Content sub-team, which developed and released an integrated protocol template and libraries for use across 20 Member Companies in June 2015 and an open access version released via the TransCelerate website in December 2015. In 2018, the team released the first templates for a Common Statistical Analysis Plan and a Common Clinical Study Report. This suite of templates is reviewed and updated, if required, annually at a minimum. I presented at multiple global fora and met with regulatory and other global consortia on behalf of the group to spread awareness and ensure alignment with industry and health authorities.