First of all, we hope you and your families are keeping well during these uncertain times.
As you all know, statisticians across the globe and across industry are actively involved in trying to understand and address the impact of COVID-19 on pharmaceutical development, including the safety of the patients in our trials and the integrity and interpretability of the data we collect. There are many ongoing efforts, where members from PSI and other organizations, as well as companies, are partnering to address the impact on clinical trials – thank you for all your efforts!
A number of regulatory agencies and other groups have issued guidance in response to the impact of COVID-19 on clinical trials and clinical research. This includes the FDA, EMA, CTFG and others. Please check the regulatory agency websites to obtain the latest guidance. The PSI/EFSPI regulatory committee has reached out to European regulators to volunteer our help, and to discuss and work on specific topics. The committee also collaborated with EFPIA to review and collate comments on the draft points to consider document that the EMA Biostatistics Working Party (BSWP) released, 'Points to consider on implications of Coronavirus disease (COVID-19) on methodological aspects of ongoing clinical trials'
. Some of the key items from the consolidated comments were as follows:
• Data Monitoring Committee (DMC)
: the draft PtC suggests a major role for a DMC in making important decisions in ongoing trials. Many of these responsibilities belong to sponsor trial management personnel, as the associated issues can be addressed without access to unblinded data. If important decisions are advised by unblinded data, this should be done through a DMC. If a DMC does not exist already, it may not be operationally feasible to establish one as suggested. We advise that the document be revised to indicate that assessing trial integrity remains the responsibility of the sponsor with DMC input and consultation as appropriate.
• Topics not addressed in the draft PtC
: there are additional topics related to the COVID-19 pandemic that are not currently addressed in the document, but it might be helpful to receive some guidance from the agency on:
o Observational studies
o Streamlining the documentation of changes resulting from the pandemic
o Modifications to success criteria
o Methods of compensation for information lost because of the pandemic
o Remote monitoring
o Glossary of terms
Thank you all who provided comments. You can find the find the full set of comments that we collated here
Also, there are draft plans for a virtual PSI session in June, where the EFPIA/EFSPI estimands implementation working group intend to share examples of the impact of COVID-19 on ongoing trials and how this could impact estimands and methods for estimation. More to come!
The PSI/EFSPI regulatory committee will continue to partner with regulators and other organizations. Please let us know if you have ideas or initiatives that can help in the understanding of the COVID-19 impact.
The PSI/EFSPI regulatory committee
through Christoph Gerlinger (EFSPI regulatory committee chair, and Anna Berglind (PSI regulatory committee chair.