REGULATION
By Deborah Borfitz
Oct. 27, 2008 | The Food and Drug Administration Amendments Act (FDAAA), enacted last year, includes a three-year timeline of requirements furthering clinical trials reporting on the World Wide Web. September 27 was the deadline for the reporting of basic results on clinicaltrials.gov and it caused some “angst” among study sponsors, says Tim Bacon, CEO of Newtown, PA-based PeerView.
“With the results requirement, sponsors…[must] disclose very granular results data within one year of completing final collection of data for the primary outcome, a data point that most sponsors were not even tracking prior to FDAAA,” says Bacon.
Reportable data include demographic and baseline characteristics of study participants, results values for each of the primary and secondary outcomes for each arm of the study, point of contact for scientific queries, and information on sponsor agreements with investigators that could restrict their ability to discuss or publish trial results.
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| Tim Bacon |
“What makes the results requirement most complicated is the format in which the results must be submitted,” says Bacon. “Rather than uploading study results that have already been compiled into a clinical study report…using clinicaltrials.gov’s online protocol registration system [PRS], sponsors must first create results tables and then enter the data and statistical analyses.”
Adding the results to the trial listing increases the transparency of the drug development process to the public, which is what the FDAAA intended, says Bacon. Stiff penalties and fines can be levied against sponsors for noncompliance. “Even if sponsors currently have results listed on their Web page or in another like repository, such as clinicalstudyresults.org, they are still required to post to clinicaltrials.gov.”
Of the top pharmaceutical and biotechnology companies surveyed by PeerView, seven out of ten indicated they had links to trial results on their own Web page. “It is a credible action on the sponsors’ behalf and it shows that they are committed to the process,” says Bacon.
The December 26, 2007, clinical trials listing requirement led to a doubling of new trial registrations at clinicaltrials.gov, from 250 to nearly 500 weekly. Other studies already registered had to be modified to include the additional required data sets.
Bacon, whose company provides an interface application to help with this registration process, says that the FDAAA and its requirements are only part of the disclosure picture. “The biggest red flag on the horizon is what’s going on in the rest of the world.” A growing number of countries are evaluating similar mandatory registries, but it remains to be seen what data will be required, in what language, and how the information will need to be posted. Over the next six to 18 months, sponsors will increasingly be “scanning” the regulatory horizon for answers.
Meanwhile, sponsors may be turning to PeerView for assistance with the next stages of FDAAA implementation. The company’s Veritas Clinical Trial Register (VCTR) system helps standardize the process as well as create and capture the data that gets fed into clinicaltrials.gov.
The PeerView system features error and fact checking so that data can be accurately inputted into PRS, which “only accepts certain characters and rejects others,” says Bacon. Regularly scheduled data feeds into clinical trial management systems also get imported into VCTR to create data sets that can be standardized to clinicaltrials.gov and clinicalstudyresults.org. The information then gets routed to various internal authorities for approval before posting to the public registries. “This helps because the various clinical teams may be using different languages and this can standardize their wording and process.”
The next FDAAA deadline is March 2009, when sponsors are required to start adding information on serious and frequent adverse events, says Bacon.
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