The regulator is stepping up pressure on the pharmaceutical and scientific industries to improve transparency

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The FDA has sounded the alarm over a lack of transparency in biomedical research after finding that around 30% of clinical trials registered in the United States have not reported their results. To address this situation, the agency has sent notices to more than 2,200 pharmaceutical companies, medical device manufacturers and researchers responsible for some 3,000 studies.

According to the agency, this lack of information distorts the available scientific evidence, as it tends to overestimate positive results and conceal failures. This can directly affect perceptions of the efficacy and safety of medicines and healthcare technologies, with potential implications for clinical practice.

FDA Commissioner Marty Makary was emphatic on the matter: “All too often, companies conceal unfavourable results from clinical trials, keeping them out of reach of patients and healthcare professionals.” In this regard, he stressed that doctors need full access to the data to make informed decisions about treatments.

Companies are concealing unfavourable results from clinical trials, keeping them out of reach of patients and healthcare professionals

Current US regulations require clinical trial sponsors to publish results within one year of the study’s completion, although there are exceptions, such as phase 1 trials, initial safety studies or feasibility studies on medical devices.

In this initial phase, the FDA has opted to encourage voluntary compliance through reminders sent out recently. However, the regulator warns of possible enforcement measures in the event of non-compliance, including warning letters and even formal notices with financial penalties of up to $10,000.

Encourage compliance through recently sent reminders

In recent years, the agency has progressively stepped up its activity in this area. Over the past 13 years, it has issued more than 230 preliminary notices, although since 2021 it has issued only eight formal notices of non-compliance. Notable cases include warnings to companies such as Acceleron and Ocugen for delays in publishing data.

This move marks a significant step towards stricter regulatory requirements regarding transparency, at a time when the integrity of clinical data is key to ensuring confidence in biomedical innovation and patient safety.