The Labour MEP from the UK who is the parliamentary rapporteur for the European Commission’s proposed revisions to the Clinical Trials Directive wants to see tougher measures in the regulation to ensure comprehensive data from clinical trials are made publicly available.
Transparency campaigners such as the AllTrials initiative have voiced concerns about the lack of measures in the proposed regulation to ensure comprehensive registration and reporting of trials of medicines currently in use.
For example, Article 34, paragraph 3 of the text published by the Commission last July requires sponsors to submit a “summary of results” to the EU’s clinical-trial database within one year of a study ending.
In her rapporteur’s report, which will be voted on in the European Parliament’s Committee on Environment and Public Health, Glenis Willmott has amended the provision to read: “Within one year from the end of a clinical trial, the sponsor shall submit to the EU database the clinical study report, including a lay summary of the clinical trial”.
Willmott, who is leader of the European Parliamentary Labour Party and Labour member of the European Parliament for East Midlands.
A ‘clinical study report’ is defined as “a report containing the full protocol and any subsequent modifications and dates thereof, a statistical analysis plan, summarised efficacy and safety data on all outcomes, and individual anonymised patient data in the form of tabulations or listings, in accordance with the guidelines provided by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use on the structure and content of clinical study reports (ICH E3)”.
Increased transparency
The justification given for the amendment is that introducing a clinical study report is “in the interest of increased transparency. 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”.
Willmott’s report also proposes that clinical trial data “should not be considered commercially confidential once a marketing authorisation has been obtained”.
The Commission’s Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use will repeal the existing, and much-criticised Clinical Trials Directive Directive 2001/20/EC.
Financial penalties
In addition, Willmott wants to see financial penalties imposed on trial sponsors who do not upload their results on time. US law requires all study results to be logged on the clinicaltrials.gov database within a year, but an audit last year found that 80% of trials had failed to comply, she noted.
“If we are serious about openness in medicine then we have to levy fines on those not following the rules,” Willmott commented.
“I am calling for wide-ranging transparency measures,” she said. That includes having “comprehensive results” from clinical trials available on a public database.
“A summary of the results is not enough,” Willmott added. “Summaries written by those that carried out the research can be biased, and make a medicine sound more successful than it really is. Independent researchers need access to the results of the trial in order to verify the sponsor’s claims.”
A clinical study report is the same document as companies have to file with regulators to obtain marketing approval for a medicine, “and therefore contains a full account of how the clinical trial was conducted and what the results were”, Willmott pointed out.
