Researchers seeking clinical trial data on particular drugs or conditions can check online registries such as the US National Institutes of Health (NIH)’s ClinicalTrials.gov, but the information they find there is often hard to navigate and incomplete. Now, the Repository of Registered Analgesic Clinical Trials (RReACT) database seeks to fill the gap for the pain field by compiling information on pain therapeutic trials—including any publicly available outcomes data. The database is a project of ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks), a public-private partnership among academics, industry, the NIH, and the US Food and Drug Administration (FDA).
RReACT offers pain researchers a user-friendly, one-stop shop for clinical trial information. In addition, by cataloguing the few reports that exist on trial outcomes, the database could spur efforts to improve outcomes reporting. “I’m hoping that it will light a fire for the FDA, the NIH, and all the [trial] sponsors to push harder to get study results posted somewhere,” said ACTTION executive committee member Michael Rowbotham, who, with colleague Kaitlin Greene, both from California Pacific Medical Center Research Institute in San Francisco, US, designed and compiled the database. The group posted the database on the ACTTION website July 30, and introduced it in a review published online July 15 in the journal Pain.
RReACT includes all analgesic drug trials registered at ClinicalTrials.gov for three of the most heavily studied chronic pain conditions: post-herpetic neuralgia, fibromyalgia, and diabetic peripheral neuropathy (373 trials total). All information is current as of December 1, 2011. For each study, the database gathers information such as trial status, design, and sponsor, as well as drug type, mechanism of action, and route of administration.
Most valuably, RReACT amasses the few outcomes data that currently exist, and hyperlinks to the source of that information. The team found that, for many clinical trials, no such data were available. Of completed trials, only approximately 40 percent had been published in peer-reviewed journals. Even when the researchers restricted their analysis to trials that had been completed before 2010, and considered reports in “grey literature” such as press releases and meeting abstracts, they found results for only about three-quarters of trials.
Another issue that RReACT brings to light is that, even when outcomes data do appear on the Internet, the information can disappear quickly. In particular, the industry-sponsored ClinicalStudyResults.org—the source of much of the outcome information in RReACT—is now offline. A representative from the group that created ClinicalStudyResults.org, the Pharmaceutical Research and Manufacturers of America (PhRMA), told PRF that the organization phased out its results repository last year and hopes that, over time, companies will post more results on ClinicalTrials.gov. (US law mandates that investigators and sponsors submit results to ClinicalTrials.gov for most drug trials, although results are still lacking for many studies. For more information, see ClinicalTrials.gov and Zarin et al., 2011.)
Rowbotham said he and his colleagues will keep checking to see if the missing outcome data do appear. They plan to post updated versions of RReACT two to three times per year—adding new trials and also expanding to other pain conditions. “As the database gets bigger, it will provide a much more wide-screen, high-resolution snapshot of the pain research landscape,” he said.