Approvals Of Medicines from Regulatory Agencies Despite Omitted Clinical Trials

As per a post dated 3rd January, 2022 on TranspariMED, a drug to treat attention deficit hyperactivity disorder (ADHD) was approved by several regulatory agencies without all relevant clinical trials having been reviewed, a study published in November 2021 suggests.

The omitted trials accounted for a median of 45% of all data from participants in relevant studies, raising concerns that regulators may not be looking at all relevant trials when assessing the safety and efficacy of new treatments.

Six regulators did not consistently list all relevant trials in public approval documents: BfArM (Germany), FDA (United States), Health Canada, MHRA (United Kingdom), PMDA (Japan) and TGA (Australia). With the exception of Health Canada, regulators did not explain why certain trials were omitted.

The researchers identified 18 relevant trials and 13 drug applications filed with 7 different regulators by four pharma companies: Janssen, Medice, Novartis, and Purdue. They found that in just over half of regulatory documents, relevant clinical trials were not mentioned.

The authors recommend that regulatory agencies should systematically search for trials themselves, rather than relying on drug companies to identify all relevant studies, and that pharma companies should be held accountable if they fail to inform regulatory agencies about all available evidence.

For more details, please refer to this post on TranspariMED.