A closer look at the ClinicalTrials platform

Clinical trial registry errors could delay new treatments

One of the world’s largest platforms for registering clinical trials, ClinicalTrials.gov, run by the US government, relies heavily on the good faith of researchers to ensure the veracity of information such as the completion date and the number of patients involved in the study, revealed a study by The Scientist.

The information, which is not verified by government agencies or platform staff, can make a difference to study participants and other researchers who need to use the findings. Difficulty with the platform’s terminology is one of the factors inhibiting users from properly filling out records, which ultimately delays access to results from new treatment studies.

When examining a set of clinical trials for COVID-19, the journal’s senior editor, Catherine Offord, noted that trial completion dates could be off by months or even years. This discovery implies that many studies could be in violation of relevant reporting standards.

Regulatory agencies and research-funding agencies use the dates entered by researchers or study sponsors to determine legal deadlines by which the results must be reported. These rules, in theory, should guarantee timely public access to findings about the potential benefits and dangers of new treatments.

In certain cases, failure to comply with the deadline could result in a fine of more than US$10,000 per day and the cancelation of public funding. The purpose is to dissuade researchers from omitting negative results or other information that could be used by doctors or researchers who want to use the same treatment on other patients.

Anna Fine, the director of ClinicalTrials.gov, responded to the journal, stating that at the start of the pandemic, scientists were encouraged to register studies about SARS-CoV-2 and COVID-19 on the platform as quickly as possible, which may have made it difficult to meet deadlines. The platform’s representative also said that she would consider ways to provide and disseminate clarifications on defining the trial completion date.

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