Legislators this week endorsed revamped regulations that would streamline clinical trials of new medicines, making such trials both cheaper and faster while still ensuring patient safety.

European Parliament's Environment, Public Health and Food Safety Committee unanimously approved the proposal, which backers say provides simpler reporting procedures and would encourage research. The law would replace the Clinical Trials Directive adopted in 2001, which was roundly criticized by researchers for inflating costs and red tape with little benefit to patients.

Member of parliament Glenis Willmott, who authored the report on the proposal, said the number of clinical trial requests in Europe fell by 25 percent from 2007 to 2011. During that same timeframe, the length of time needed to launch a trial almost doubled to 152 days.

“The aims of the (2001) directive were admirable, but many of the requirements were geared towards trials sponsored by pharmaceutical companies, while those with non-commercial sponsors were overlooked, and true harmonization was never achieved," Willmott said in a statement. “Getting better legislation in place soon is crucial to enable and encourage life-saving research.”

Among the new provisions, member states must respond to application dossiers within fixed deadlines. Reporting procedures would be simpler and the European Commission would be allowed to perform checks. Transparency for the public would be enhanced by requiring sponsors to publish detailed summaries in a publicly accessible database as well as full clinical study reports once a decision on authorization is finished. Any sponsor not complying with the regulations would be subject to fines.

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Also new in the revamped legislation are special provisions for what are considered to be low-risk clinical trials. For low-risk trials, compensation for damages would fall under the national security or national health care system. Sponsors would be held liable in other trials not deemed to be low risk. However, they also could use a national indemnification system to be set up by member states. That, the report says, would help tamp down high insurance costs, which could help academics in particular.

Ethics committees would have clearer roles in authorizing clinical trials, and more detailed rules on obtaining patients' informed consent are established. Specific rules are proposed for pregnant or breastfeeding women, prisoners, and those with special needs.

The legislative overhaul was prompted by industry complaints over the added bureaucracy. Researchers feared Europe would lose out on large-scale trials and be at a competitive disadvantage.

MEP Philippe Juvin, who represented the European People's Party on the proposal, praised the development as a huge advance for clinical research across Europe.

“Compared to our Canadian and American competitors, these timelines will be more competitive,” Juvin said following the vote. “Then, the regulation will finally cover the emergency clinical trials. This category has been covered by American law since 1996, and French law since 1988.”

The European Federation of Pharmaceutical Industries and Associations (EFPIA) praised the proposal's intent of streamlining the regulatory process surrounding clinical trials. However, the association is urging members of parliament to take another look at specifics regarding the sharing of clinical data. The association expressed fears that such requirements could jeopardize patient confidentiality and commercially sensitive data.

“EFPIA member companies support ongoing efforts to continue improving the diverse means of sharing clinical trial data to benefit patients, foster scientific discovery, and support ongoing investment into innovation,” Richard Bergstrom, director general of EFPIA, said in a statement. “This requires industry, regulators, researchers, and society to work together to ensure that patient privacy, the integrity of regulatory systems, and incentives to invest in biomedical research are maintained.”

Bergstrom's group has pledged to continue working with lawmakers to ensure the revised directive does not result in “bad science harming public health.”

On the transparency aspect of the proposal, the European Consumers' Organisation expressed doubts the results of clinical trials would actually be published. Not requiring clinical data to be shared would be a missed opportunity for consumers to get full safety information on medicines, according to the group.

Now that the public health committee has endorsed the proposal, Willmott will begin negotiations with EU ministers. A plenary discussion on the proposed directive is scheduled for October.

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