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New UK Clinical Trials Transparency Legislation

The government has announced plans to overhaul the legislation that governs clinical trials, to introduce a series of measures to make it faster and easier to run clinical trials in the UK, and prioritises transparency in clinical trials. The Medicines and Healthcare Products Regulatory Agency (MHRA) recently undertook a consultation on new clinical trial legislation, and the government’s response includes plans to require prospective trial registration and reporting of results within 12 months, with overwhelming support from respondents to the consultation.

According to an article recently published in the BMJ, effective enforcement is crucial to ensure the success of these transparency measures. Regulators must demonstrate their commitment to enforcing sanctions for non-compliance will be enforced and reject applications from trialists with a history of breaching reporting obligations. A robust audit infrastructure is also necessary to monitor compliance and identify potential breaches.

The article, by Nicholas DeVito and Ben Goldacre, emphasises the importance of clear guidelines and alignment of rules and regulations across registries to make compliance convenient for sponsors and facilitate multinational trials. The goal of these efforts is to build trust in UK clinical trials by promoting transparency, offering reliable trial results for clinicians and patients to make informed decisions about treatments.

The full article can be viewed here.