Research in context
Evidence before this study
Non-reporting of clinical trial results has been well documented for several decades, and represents a substantial threat to the integrity of the evidence base for all of clinical medicine. The Food and Drug Administration Amendments Act (FDAAA) of 2007 aimed to address this issue. Previous studies examining compliance were hindered by ambiguities in the legislation and incomplete data that blocked identification of applicable trials; most studies only included small subsets of trials. The Final Rule clarifying the Act was implemented in 2017. A search of PubMed and Google Scholar for “FDA Amendments Act” finds no complete assessment of compliance with the Final Rule. Compliance with similar new EU rules on trial reporting was assessed in 2018 and was found to be poor, with only 3601 (49·5%) of 7274 trials reporting results.
Added value of this study
To our knowledge, this is the first study to assess compliance with the Final Rule of the FDAAA of 2007. This law was widely celebrated as a solution to the problems of publication bias and clinical trial reporting. Our findings raise important questions around lack of enforcement and the need for public accountability. All our data and software for downloading, processing, and analysing raw data are shared openly for independent review and re-use; this is the gold standard for reproducibility and facilitates other researchers in the field. We will maintain updated compliance data for each individual sponsor and trial at fdaaa.trialstracker.net as an open public service to help sponsors who aim to comply fully with the law.
Implications of all the available evidence
The FDAAA 2007 was reasonably expected to ensure results reporting for the large number of trials conducted under the regulatory authority of the USA. Using data extracted from ClinicalTrials.gov up to Sept 16, 2019, our findings show that compliance has been poor and is not improving. It is encouraging to note that results reporting is more common among trials with an industry sponsor, and among those conducted by a sponsor with a large number of registered trials. This suggests that research experience and robust internal governance processes can contribute to improved performance. However, with 2487 trials conservatively identified as breaching the law in our study, it is concerning to note there has been no enforcement by the FDA to date. Action by regulators would improve compliance; until then, public accountability through tools such as fdaaa.trialstracker.net could help.