Dear Pharmacovigilance and Regulatory colleagues,
I was hoping that you might be able to provide some advice on unblinding of SUSARs to health authorities when the event is thought related to the comparator product (ie APPROVED PRODUCT A). We have an ongoing study of APPROVED PRODUCT A with placebo (SOC) vs. APPROVED PRODUCT A + our investigational drug (ie INVESTIGATIONAL PRODUCT A).
We submitted a blinded report for our study as the investigator assessed causality to the comparator product APPROVED PRODUCT A and not to our investigational drug. However the MHRA are insisting that we unblind the case regardless. For background both APPROVED PRODUCT A and INVESTIGATIONAL PRODUCT A are listed on the EudraCT form as IMP.
MHRA has responded and said the report is invalid because we submitted it blinded. We have continued to refuse to unblind as this would set a new precedent for how we handle safety reporting in Europe. The MHRA sent a further response and provided a link to their MHRA webpage https://mhrainspectorate.blog.gov.uk/2019/04/09/how-to-manage-safety-reporting-in-a-blinded-trial/. One thing to note is that we have had other cases in the past which were accepted by MHRA for which we did not unblind if related to APPROVED PRODUCT A only.
Is this a new trend or is this the UK deviating from the rest of Europe? Would appreciate it if you have knowledge of this or could share with you PV colleagues how they report these events.
Many thanks in advance, Cheryl
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Cheryl Madsen RAC
San Francisco, CA
United States
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