Management of risk is inherent to the conduct of pharmaceutical research including the conduct of clinical trials. During the current COVID-19 pandemic, regulatory and compliance risk is an acute concern by health authorities, pharmaceutical manufacturers, medical practitioners and patients. Navigating the expectations of global health authorities for conducting clinical studies and COVID-19 impact is challenging.
This webinar will discuss the challenges and potential mitigation strategies, in accordance with appropriate application of regulations and COVID-19 guidance documents, to ensure GCP compliance with respect to managing lost to follow-up and missing data:
- The impact of deviations from the protocol due to shelter-in-place orders and onset of COVID-19 symptoms.
- The increased risk of bias in the results of a trial and assessing the internal and external validity of study results.
- Ensuring that clinical trial data collected during the COVID-19 pandemic remains in compliance with Health Authority guidance.
- Continuity of clinical trial oversight by Sponsors and Health Authorities to maintain data integrity.
- Statistical approaches for evaluating the impact of COVID-19 pandemic.