Publish or Perish - Pharmaceutical Executive

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Publish or Perish

Pharmaceutical Executive


Maine adds teeth—and results disclosure In June 2005, the state of Maine enacted legislation requiring both trial registration and disclosure of results of any Phase II through IV clinical trials initiated after October 15, 2002, for any drug prescribed, dispensed, or promoted in the state. The law allowed sponsors to register these trials on their Web site or at ClinicalTrials.gov/, but also required them to post a summary of trial results in the International Committee of Harmonization E3 (ICH-E3) format—which dictates the content and format of information—within one year of study completion. The legislation states that companies must post these data on a publicly accessible Web site. Many sponsors have met this requirement by posting to the industry-sponsored Web site, http://ClinicalStudyResults.org/, while others simply post summaries to their own clinical registry Web site. Still others do both. Maine also added a $10,000 penalty for non-compliance—the first monetary sanction in this escalating series of regulations. The law remains in effect.

FDAAA: A strengthened Federal mandate Lastly—at least so far—the US government signed the FDA Amendments Act (FDAAA) into law in September 2007. Like FDAMA, FDAAA is broad in focus, but its implications for clinical trial disclosure are clear—more information is required for more trials, and results are officially demanded.

Title VIII of FDAAA expanded the registration requirements from FDAMA's original 113 regulations in two ways. First, the scope of trials covered is dramatically increased to include all controlled interventional trials in patients. Trials for medical devices are required in addition to those in drugs, biologics, and for all conditions. Only Phase I trials are excluded. Second, the required data elements for registration have been expanded to include, for example, detailed intervention data, a primary outcome completion date, and primary and secondary outcome measures.

FDAAA further mandated that beginning in September 2008, and expanding in each of the two subsequent years, the results of clinical trials for approved drugs and devices will be publicly disclosed on ClinicalTrials.gov/, and should include detailed tables of data on participant flow, primary and secondary outcome measure results, serious and frequent adverse events, and eventually technical and lay results summaries.

Finally, noncompliance comes with both monetary penalties and, perhaps more important for a company's image, public "shaming" on a government Web site. The government also increased monetary penalties to $10,000 per violation, up to $10,000/day for uncorrected violations after 30 days.

International initiatives More countries are now following the lead of the US with active or pending initiatives surrounding clinical data disclosure. In some countries, these initiatives are voluntary, but many countries are moving toward mandatory requirements as a component of the regulatory submission process.


Selected International Disclosure Initiatives
Nations such as Brazil, Australia, China, New Zealand, and Croatia have already stated their plans to implement registry requirements in the near future. (See "Selected International Disclosure Initiatives") In Europe, sponsors must submit clinical trial information to the European Union Drug Regulating Authorities Clinical Trials, or EudraCT, a database of all clinical trials in Europe. While access to this database is currently restricted to European regulators, information covering pediatric studies is expected to be made public—tentatively scheduled for Q1 2009. In coming months and years, new international regulations and registry requirements from many more countries will become law, each presenting its own set of compliance requirements and its own mechanisms for updating its portal Web site.


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