A newly-amended draft report published by the European Parliament's Committee on the Environment, Public Health and Food Safety (ENVI) seeks to advance a proposal that would overhaul the EU's clinical trials regulatory framework by repealing Directive 2001/20/EC and replacing it with a new regulation.
[Editor's note: a previous version said it would be replaced with a new Directive. It is instead being replaced with a new regulation.]
The 55-page draft includes a number of changes to an earlier iteration of the same report, which calls for dramatically increased amounts of transparency in the EU clinical trials enterprise.
One of the more prominent amendments to the text calls for trials sponsors to ensure that "the group of subjects participating in the trial represents the population to be treated," and to "provide a systematic review of the existing data on the investigational medicinal products."
At present, some trials may exclude some subjects from participation if they do not meet ideal enrolment criteria. This requirement could potentially lead to regulators requiring the participation of more elderly subjects, for example.
Changes also call for the inclusion of ethics committees composed of lay persons, patients and healthcare professionals. Prior language indicated that Member States should consult lay persons and patients not affiliated with any particular ethics committee when approving a trial (assessment procedure). Legislators also called the current ethics review procedure fragments, and said it "should be better harmonised through the sharing of best practices between ethics committees. To this end the Commission should facilitate the cooperation of ethics committees."
The amended text also calls for sponsors to communicate to regulatory officials the reason for the withdrawal of any clinical trial application and for any new application to contain an explanation of any previous withdrawals.
All data submitted in support of a clinical trial application should be based on clinical trials recorded in publicly accessible databases, legislators wrote. Older trials not present in databases should be registered before being referred to "for the sake of reliability."
Importantly, "Clinical trial data should not be considered commercially confidential once a marketing authorisation has been obtained," legislators wrote. "For the sake of transparency, once a clinical trial has led to marketing authorisation, data generated during the clinical trial should be fully accessible.
That text would represent a dramatic expansion of clinical trials transparency, and would be similar in nature to proposals made by the AllTrials.net initiative supported by a number of prominent groups, academics, and, as of 5 February 2013, GlaxoSmithKline.
Legislators also proposed requiring companies to generate standardized clinical study reports (CSRs) using International Conference on Harmonisation (ICH) guidelines (ICH E3).
"The introduction of the clinical study report is in the interest of increased transparency," legislators explained. "These are internationally accepted guidelines on preparing a full description of a clinical trial and its results. This will help sponsors provide harmonised information, and increase transparency by greatly increasing the amount of data available to the public and independent researchers.
The draft will now undergo consideration by the European Commission (EC), which can refer the matter back to the European Parliament for recommended amendments or propose an entirely new set of rules. The draft is also being distributed to national parliaments for consideration, legislators said.