The EMA issued a new policy for the publication of clinical studies

Under pressure from transparency advocates, the European Medicines Agency (EMA) recently unveiled new policies for the publication of clinical trial results. The EMA said the new policy would apply to all centralized listing licence applications submitted from January 1 next year, adding that clinical studies (CSRs) would be published when deciding to report information.
the first phase of the program will only provide CSRs, which can be accessed anonymously, and patient-level data after a period of discussion and "resolution of various legal and technical issues related to access to patient data." The EMA also indicated that the policy would serve as a "complementary tool" before the implementation of euthan transparency rules for clinical trials, which are scheduled to be implemented by May 2016.
EMA said the new policy would apply to new drugs that will be declared next year and extend to existing products from July 1, 2015. EMA Chief Executive Ema Rasi said the new policy "sets new transparency standards for public health and drug research and development", but Transparency said two of the three main issues remained unresolved and set up a Twitter campaign to try to influence the recent vote.
AllTrials campaign welcomed the decision to lift restrictions on researchers' access to CSRs, which were suggested in an earlier draft policy to be viewable, not saved or printed, but said other parts of the policy remained a concern for researchers.
is that the editing of clinical study information is the responsibility of the trial authors, which means that they "can propose which of the information submitted to the EMA should be blocked," AllTrials said. Deciding which information is a trade secret is still a gray area.
At the same time, if the trial bidders believe that the provisions of the data terms of the contract have been violated, they can take direct legal action against the researchers, making it "easy for individual scientists to get involved in legal battles with large pharmaceutical companies, thereby introducing a new unpredictable high legal cost risk into routine academic work," AllTrials said.
" clinical trial bidders may still be able to delete anything they don't want others to see," commented Brown, managing director of the charity SenseAboutScience, which is trying to encourage an evidence-based approach to technology development. "Companies and other groups that welcome open access to their clinical trials have made it clear that the content that needs to be edited is very limited," she added.
same time, BadPharma author Goldacre also expressed concern about the editing process, noting that the EMA and AbbVie reached a consensus this year to "review CSR's public release of changes to the program." "The change in the scheme in the trial is precisely the information that researchers need to make informed decisions about whether the trial is a 'fair test' of the drug," he said. "In an experiment eight years ago, it was hard to see how reasonable it was to block program change information on the grounds of trade secrets."
EMA stressed that blocking content could only be proposed on commercial grounds in "limited circumstances" and that the decision to block it depended on the EMA. The new policy will help "avoid duplication of clinical trials, promote new drugs and encourage the development of new drugs" by increasing public confidence in the EMA's decision-making process and allowing researchers to re-evaluate data sets.
EU consumer group BEUC said it would further increase transparency in clinical trials if the policy were implemented by EU regulators, but warned that the guidelines were "not static and could face further disruption." in particular,
noted that legal challenges such as those initiated by AbbVie and InterMune could re-occur, and that ongoing discussions on trade secrets in the context of the Transatlantic Trade and Investment Cooperation (TTIP) could be cancelled. The planned shift from the EU Health Council to the industry's pharmaceutical policy is also "uncertain," the group said. (Lilac Garden)