Maintaining Trial Integrity During COVID-19: Some Statistical Rules Of Thumb

The COVID-19 pandemic is having a substantial impact on many ongoing clinical studies in all phases of product development. Numerous difficult decisions are being made and steps are actively being taken to ensure the safe execution, or future resumption, of ongoing studies. While patient safety is paramount and should drive all study conduct related decisions, many of these decisions can impact the interpretability of estimates of efficacy at study conclusion. Changes that may seem innocuous on the surface can have a substantial impact on trial integrity, including the validity and reliability of results. Careful consideration, in consultation with a statistician, should be given to the impact that protocol changes, visit schedule amendments, collection methods, and incomplete or missing information will have on the final analysis and interpretation of results.