The FDA advises that modifications to primary or key secondary endpoints would generally require a protocol amendment or an investigational device exemption (IDE) supplement.

The U.S. Food and Administration (FDA) issued its statistical guidance report for June 2020. This latest document is a series of FDA guidance reports that are created to keep medical experts, healthcare personnel, and others informed on the latest FDA research statistics and analysis for the COVID-19 public health emergency (PHE).

According to the FDA, the documents do not create or confer any rights for or on any person, and they do not operate in a way that would restrict or generally limit the Agency and its operation.  

The current FDA guidance report addresses the collection and the analysis of data during a clinical trial. Some previously planned critical tests were put on hold during the COVID-19 health emergency. While prioritizing the safety of trial participants, the sponsors planned to address the impact of COVID-19 on the program’s ability to meet the trial objectives.

The FDA advises that modifications to primary or key secondary endpoints would generally require a protocol amendment or an investigational device exemption (IDE) supplement. Similarly, changes to the analysis of primary or vital secondary parameters are reflected in an updated statistical analysis plan before locking the database and before any modifications to a non-blinded interim report.

When considering modifications to the trial to address the impact of COVID-19, sponsors should not propose any trial modifications based on data that may introduce bias into the interpretation of trial findings, the FDA advised. Generally, for a blinded trial, changes can be found on information that reveals the magnitude of the treatment. 

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The FDA also indicated that information not specific to individual participants, such as information on site closures and the disruption of the supply of the investigational product, may also be appropriate to use when considering modifications to the trial. 

As discussed in the Guidance summary, researchers need to capture specific information at the participant level, and must describe the context and/or reasons for post-baseline events as they relate to COVID-19. The reasons might include discontinuation of treatment, withdrawal from the trial, the use of alternative or rescue treatments, a missed endpoints, and the use of alternative endpoint ascertainment methods. This information may be useful for incorporating into analysis strategies to address potential biases or for the performance of sensitivity analyses related to the impact of COVID-19.

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The FDA counsels that for sponsors considering stopping a trial and conducting a final analysis, a significant consideration is the loss of statistical power from a smaller sample size or less follow-up time than was anticipated.

The report gathers information from the following agencies: Center for Drug Evaluation and Research; Center for Biologics Evaluation and Research; Center for Devices and Radiological Health, and the Center for Veterinary Medicine.