In May, the OpenTrialsFDA team (a collaboration between Erick Turner, Dr. Ben Goldacre and the OpenTrials team at Open Knowledge) was selected as a finalist for the Open Science Prize. Working towards a first prototype in early December, OpenTrialsFDA will make the Drug Approval Packages (DAPs) from the FDA website easily accessible and searchable and link these to documents and data related to clinical trials. Other interested parties will also be able to access, search and present this information through the application programming interfaces (APIs) the team will produce.
The Food and Drug Administration (FDA) publishes DAPs as part of the general information on drugs via its data portal known as [email protected]. These documents contain detailed information about the methods and results of clinical trials, and are unbiased, compared to reports of clinical trials in academic journals. This is because FDA reviewers require adherence to the outcomes and analytic methods prespecified in the original trial protocols, so, in contrast to most journal editors, they are unforgiving of practices such as post hoc switching of outcomes and changes to the planned statistical analyses. These review packages also often report on clinical trials that have never been published.
However, despite their high value, these FDA documents are notoriously difficult to access, aggregate, and search. The website itself is not easy to navigate, and much of the information is stored in PDFs or non-searchable image files for older drugs. As a consequence, they are rarely used by clinicians and researchers. OpenTrialsFDA will work on improving this situation, so that valuable information that is currently hidden away can be discovered, presented, and used to properly inform evidence-based treatment decisions.
The team has started to scrape the FDA website, extracting the relevant information from the PDFs through a process of OCR (optical character recognition). A new OpenTrialsFDA interface will be developed to explore and discover the FDA data. In addition, the information will be integrated into the OpenTrials database, so that for any trial for which a match exists, users can see the corresponding FDA data.
We will be sharing future progress through this blog as the work develops: the final prototype will be presented in early December at the Open Science Prize Showcase.
Contact: [email protected]
More information about the Open Science Prize: https://www.openscienceprize.org/res/p/finalists/
3 thoughts on “OpenTrialsFDA: Unlocking the trove of clinical trial data in [email protected]”
Hooray for OpenTrials. Its results in comparing the journal version of antidepressant trials with FDA information makes the case for a change of law that would require “truth in research labeling” to guide medical journal editors and their peer reviewers. All journal reports should make known whether the authors are reporting trial results in terms of the original a priori protocol submitted to the FDA for marketing approval or some post hoc departure from the original protocol. Knowing which is which would facilitate journal peer review and editor decision making. A petition to the US Congress with proposed language for amending Section 801 of the Public Health Service Act to require the FDA and NIH to coordinate in certifying that trial content submitted by responsible parties to the FDA and to ClinicalTrials.gov are identical. Journal editors could then require authors to disclose that manuscripts submitted for publication are reporting results according to the FDA protocol or not. Peer reviewers and readers of published reports based on post hoc changes in the trial content submitted to the FDA could then check for disparities in reported results. The petition to the US Congress with the proposed amendment of Section 801 of the Public Health Service Act has been submitted to the FDA in response to call for public comments on its recommendation for the sixth reauthorization of the Prescription Drug User Fee Act: http://www.regulations.gov/#!documentDetail;D=FDA-2016-N-1895-0003.
This valuable work adds to evidence that many but not all medical journals legitimate partial and selected evidence as received medical knowledge about drugs, guidelines, and clinical protocols.
It is well known that clinical research journals do not publish negative results.