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P37: Identification, Data Collection, and Medical Analysis of COVID-19 Cases Reported within Interventional Clinical Trials

Poster Presenter

Neil P Kapil

Associate Director, Clinical Safety Strategy and Solutions, WW Patient Safety
Bristol-Myers Squibb Company
United States

Objectives

The Clinical Safety Program (CSP) at Bristol Myers Squibb (BMS) is an operationally and medically driven capability that was implemented to collect data on COVID-19 cases reported in interventional clinical trials to respond to challenges associated with the pandemic and to evaluate patient safety.

Method

COVID-19 CSP case report forms (CRFs) were implemented into the clinical database (CDB) to collect additional information on patient presentation, diagnosis, clinical progression, treatment, and risk factors. COVID-19 related events were identified utilizing the MedDRA MSSO COVID-19 SMQ (Narrow).

Results

Engagement of several key stakeholders across the enterprise was required to create and implement the COVID-19 CSP CRFs, including Pharmacovigilance, Early Development, Clinical Development, Biostatistics, Data Management, and Regulatory. The following standardized medical content was defined for the COVID-19 CSP CRFs for CDB implementation to facilitate data collection: Specific Disease History (i.e., baseline comorbidities), Associated Signs and Symptoms, Suspect and Prophylactic Medications, Diagnostic Labs and Procedures, Supplemental Oxygen Saturation, Clinical Status Assessment, Treatment Medications and Procedures, and Relevant Factors (i.e., other factors that could predispose a patient to the illness). These additional data points complement data routinely collected on adverse events (AEs), such as Severity, Investigator Assessment of Relationship to Study (Causality), and Event Outcomes. The medical content was finalized following a comprehensive review of available COVID-19 literature as well as the CRFs developed by the Centers for Disease Control and Prevention for COVID-19 cases. MedDRA MSSO COVID-19 SMQ (Narrow) was utilized to identify reported verbatim events from investigative sites within the CDB for suspected or confirmed COVID-19 infections as well as AEs related to COVID-19 vaccination. COVID-19 CSP CRFs were issued to investigative sites for completion for all AEs that mapped to the pre-defined MedDRA preferred terms. Studies were prioritized for COVID-19 CSP CRF implementation based on numerous factors, such as size of the study, stage of development, study phase, whether the study is being operationalized in-house or via a clinical research organization, as well as timing of database locks and clinical study report (CSR) generation. Discussions with Compliance and Regulatory were required to ensure that the additional data being collected was aligned with Protocol Model Documents and was acceptable from a regulatory perspective.

Conclusion

In our experience, the CSP capability of standardized and uniform collection of additional safety data in relation to AEs of interest (AEOI) allows us to proactively understand the course of safety events and add significant value to our developmental programs. We have successfully launched the COVID-19 CSP CRFs in conjunction with the BMS R&D Clinical Research COVID-19 Project Management Office as part of our rapid response to the pandemic. COVID-19 CSP data will be reviewed for completeness and accuracy to allow for exploratory analysis and visualizations to be constructed and presented to Safety Data Review & Safety Management Teams and potentially be incorporated into various stakeholder deliverables, including CSRs, case narratives, and responses to health authority queries. This additional data collection and analysis will inform us regarding the course of the COVID-19 infection and impact of vaccine-related AEs across our patient populations within interventional clinical trials. It will enable BMS to further document and describe COVID-19 events for a better understanding of product profile, patient safety, and underlying conditions. Since there is limited knowledge of COVID-19, there is even greater opportunity for CSP data utility, such as testing hypotheses for potential alternative treatments. These efforts demonstrate the importance and value of targeted collection of additional safety data in relation to AEOI. Lessons learned may help drive discussions within the pharmaceutical industry and with regulatory authorities. Co-Authors: Michael Richardson, Daniel Seekins, Marla Hochfeld, Eugene Hayden, Andres Gomez, Jeremy Jokinen, Christine Kratt, Varsha Lalchandani, Lesley Alphonso, Judith Aragona, Gayle Schwartz, Janet Curll, Nicole Catena, Lauren Detoro, Deborah Meyers, Rohit Kumar, John Simon, Rozerpal Singh, Erin Heaning, William Crerand, Laurence Thomas, Vidya Sudhakaran, Corinne Beeckmans, Tomomi Dyer, Rima Peret, & Shawn Silverstein.