Regulations that would make sweeping changes to the way clinical trials are regulated in the EU took a step closer to becoming reality yesterday.
The European Parliament’s Committee on Environment and Public Health (ENVI) adopted the draft rules at a meeting yesterday, voting to include a series of amendments to an earlier document proposed by committee rapporteur Glenis Willmott. The next step is to negotiate an agreement with EU ministers to try to take the legislation forward.
The proposals introduce a series of new measures, including the creation of a public EU-wide database for all clinical trials of new medicines, with a single portal for clinical trial applications and a streamlined system of review and authorisation.
The simpler processes have been broadly supported by industry, although less welcomed was an amendment to boost transparency by requiring the outcome of studies to be published in the database within a year of their completion, with fines imposed if sponsors do not comply.
The European Federation of Pharmaceutical Industries and Associations (EFPIA) welcomed the overarching aims of the proposals but took issue with the transparency measures, describing them as “unbalanced”.
“All EFPIA member companies support enhanced sharing of their clinical trial information as a tool to broaden knowledge about our medicines in the best interest of patients and public health,” it says in a statement.
“At the same time, there is a need to protect patient confidentiality and commercially sensitive information. Several of the amendments supported by the ENVI committee will jeopardise patient privacy, the integrity of regulatory systems, and incentives for investment in biomedical research in Europe,” it claims.
Transparency advocates – including the AllTrials initiative set up by the British Medical Journal (BMJ), the James Lind Initiative, the Centre for Evidence-Based Medicine and transparency activist Ben Goldacre – had argued that the preliminary draft of the revisions to the Clinical Trials Directive (2001/20/EC) had not gone for enough on clinical trial data disclosure.
Even the latest amendments fall short of the full disclosure called for in some quarters, as the transparency provisions would, for example, not apply to trials that are already completed. However, it has tightened up requirements in the previous draft by requiring that full clinical study reports (CSRs) – the documents detailing the design, methods and results of trials – be filed for newly-approved medicines.
Willmott also says the first iteration of the CTD was “geared towards trials sponsored by pharmaceutical companies” rather than non-commercial sponsors and has been blamed for an increase in unnecessary bureaucracy.
“Between 2007 and 2011, the number of clinical trials started in Europe fell by 25 per cent,” she said after the meeting yesterday. “Getting better legislation in place soon is crucial to enable and encourage life-saving research.”
Other amendments adopted yesterday included specific provisions for low-risk trials, with compensation for damages covered in these cases by the general compensation system established under the national security or health care system.
For riskier trials, the sponsor would be deemed liable for damages but the regulations would also require Member States to set up national indemnification schemes to reduce high insurance costs.
The role of ethics committees in authorising clinical trials has also been clarified, with rules on obtaining a person’s informed consent to taking part in a trial laid down in detail.
Specific rules would also apply to clinical trials on pregnant or breastfeeding women, on persons deprived of liberty and on people with specific needs, according to the ENVI committee.