How do I know if a new medicine is safe? Clinical trial data transparency

Data from clinical trials, such as those we have become familiar with recently for the COVID vaccines, is key to understanding the effectiveness and potential side effects of any new treatment. These clinical study reports from sponsors – typically pharmaceutical and medical device companies – are reviewed by regulators such as the FDA, EMA and MHRA worldwide when assessing whether new medicines or devices are safe and effective, before making them widely available to patients. However, a recent report concluded that “notable gaps” in the quality and availability of clinical trial data in a European registry “harms both patients and taxpayers” who typically fund these studies. A similar finding was also reported in the US last year.

The report notes that 14 of the most important national regulators in Europe have failed to ensure the publication of at least 5,976 clinical trial results. Italy performed worst, with an estimated 1,221 trials missing results, followed by Spain with 884 results missing, and the Netherlands, whose regulator failed to ensure publication of 839 trial results.

I recently gave a talk at the Evidence-Based Toxicology Collaboration (EBTC) Scientific Symposium : Overcoming data availability obstacles in the way of evidence-based toxicology describing how missing or misrepresented data from both preclinical studies carried out before human clinical trials – where drugs are tested in both animals and in cells or tissues often derived from human samples – and clinical studies, can have major ramifications for the apparent safety and effectiveness of drugs which are selected for development and subsequently marketed as treatments. One such example was reported very recently for antihypertensive drugs in The Lancet.

Mechanisms exist within regulatory jurisdictions to measure the quality and availability of that data but there are real concerns that 1. Sponsors are either not submitting all data or are selectively reporting data and 2. That regulators are failing to pursue sponsors to submit completed results. The authors of this report are suggesting that regulators, at least in some countries, are part of the problem with their inadequate and inconsistent oversight of this data. If it is not possible to know if a research project was carried out or a clinical trial occurred, when it was completed or whether results are available, trust and scrutiny of regulatory decisions made regarding the approval of drugs will always be compromised. Patients who are desperately waiting for new and better treatments for potentially life-threatening and debilitating diseases deserve better.

Related: ICMRA and WHO Joint Statement on Transparency and Data Integrity; Oxford TB vaccine study calls into question selective use of animal data; Retrospective harm benefit analysis of pre-clinical animal research for six treatment interventions; Publication rate in preclinical research: a plea for preregistration.

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