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
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.
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.
Selected International Disclosure Initiatives