The European Commission's proposed revision on the Clinical Trials Directive is an important step forward, but does not go far enough, says the Cochrane Collaboration, a healthcare NGO which advocates more transparency in clinical trials.
The question of transparency – what, how and when the results of clinical trials should be disclosed – has so far been seen differently by EU lawmakers who will be voting on the proposal in May.
The Commission proposal states that a detailed summary of the results using a structured format shall become publicly available after completion of the trial via an EU database.
However, even detailed summaries contain too little information about the trials, said the Cochrane Collaboration, an international not-for-profit organisation promoting accessibility of healthcare reviews.
The summaries would not enable others to assess their risk of bias and other limitations and to include them in systematic reviews, the healthcare NGO said in a statement. This means that such trials have been wasted, it argues.
The European pharmaceutical industry has taken a different view, arguing that not all data should be made public in order to protect the intellectual property generated by the trials – and their potential commercial applications. It previously stated that it supports the Commission proposal which initially put the emphasis on strengthening the EU’s attractiveness in clinical research as the most important aim of the new directive.
The Commission's proposed revision of the Clinical Trials Directive claims to be in line with the ethical principles on human testing listed in the Helsinki Declaration, but this may not be the case if only a summary is required, the Cochrane Collaboration said.
The Helsinki Declaration states that: "Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. They should adhere to accepted guidelines for ethical reporting."
The healthcare NGO said that selective reporting of trial results occurs frequently, leading to exaggerated findings of the beneficial effects of health care interventions and an underestimation of their harmful side-effects.
"As a consequence, many patients are unknowingly treated with interventions that have little or no effect and may be harmed unnecessarily. This is unethical and violates the implicit contract between healthcare researchers and patients that the aim of such research is to improve treatment of future patients," the Cochrane Collaboration said in a statement.
Backing the Parliament's rapporteur
Instead, the Cochrane Collaboration suggests to make a clinical study report publicly available, a suggestion which has also been put forward by the European Parliament's rapporteur on the Clinical Trials Directive, British MEP Glenis Willmott.
The Collaboration said the clinical study report should include the trial protocol with possible amendments, the statistical analysis plan, the results, the case report forms on which the data were collected, and a narrative account of the trial – including a description of what went wrong compared to what was planned.
In addition, there should be a summary in plain language, which can be readily understood by patients and the raw anonymous patient data in a generic file format.
"This would reduce the risk of cheating, and it would avoid introducing double standards in the EU, one for the European Medicines Agency and another for drug trials in general," the Collaboration stated.
The Cochrane Collaboration said the suggestions would speed up innovation, as drug companies may avoid repeating other companies' mistakes when they can see the data.
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The EU's Clinical Trials Directive was adopted in 2001 with a view to improving research standards and protecting patients.
But the directive has been heavily criticised by researchers who say insurance costs and red tape has increased without bringing any major benefit to patients, researchers or industry.
The Commission has therefore proposed revamping the directive to address those challenges.
Enhancing the competitiveness of clinical research was a primary aim of the directive's revision amid claims that Europe would become an unattractive place to conduct large-scale trials on potentially lucrative new medicines.
The new draft directive also speeds up how researchers get ethical approval for medical trials and seeks to improve standards in how new medicines are tested and manufactured.
- 29 May: Vote scheduled in the Parliament's Committee on Environment, Public Health and Food Safety (ENVI)
- 8 Oct.: Tentative date for vote in Parliament plenary
- Fostering EU's attractiveness in clinical research: Commission proposes to revamp rules on trials with medicines (17 July 2012)
- Clinical Trials homepage
- Proposal for a Clinical Trials Regulation - Questions and answers