COVID-19:Clinical Trial Management During the Pandemic
Jyotsana Chaudhary, MSc, Jatin Gupta, MSc and Sukanya Saha, MSc
Note: Given that the situation is continually evolving, the thoughts and opinions are formulated to keep the current situation in mind.
Regulatory agencies across the world are issuing flexible guidelines considering the COVID-19 pandemic. This is a snapshot of the key guidelines issued and the resulting implications on clinical trial sponsors and investigators.
Key Steps of Clinical Trials
Conducting a clinical trial encompasses various steps, wherein each step further includes managing and regulating several components
Summary of Guidelines Issued on Clinical Trials
Recognizing the COVID-19 impact, national regulatory agencies have issued guidelines for sponsors and investigators regarding how to conduct clinical trials.
Impact of Guideline Changes on Sponsors and Investigators
Guidelines issued by several regulatory agencies have had several implications across the key steps of conducting a clinical trial.
Key Questions and Considerations for Sponsors During COVID-19
Below are some of the key factors and questions sponsors should consider while deciding whether to suspend or continue an ongoing clinical trial and or initiate new clinical trials.
The evolving guidelines will have an impact on ongoing and planned trials, data assessments, milestone thresholds and clinical development plans for products in the pipeline. Keeping a close eye on the evolving guidelines and monitoring the changes is critical for biopharmaceutical companies to refine and formulate their clinical and regulatory strategies.Effective measures to ensure patient safety, remote monitoring of clinical trials and documentation will be key to successfully conducting clinical trials amidst the COVID-19 pandemic.