“Too many results from clinical trials are misleading, biased or missing,” according to Glenis Willmott MEP, Labour’s health spokesperson in Europe and Leader of Labour MEPs. “It is time that all pharmaceutical companies and researchers made the full results of studies on new and existing drugs publicly available.”
Mrs Willmott is the European Parliament rapporteur, or lead legislator, for the revision of the European rules on clinical trials. Her report, calling for wide-ranging transparency measures, has been released today.
“I want to see comprehensive results from clinical trials published on a public database,” said Mrs Willmott. “A summary of the results is not enough. 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.”
Mrs Willmott is proposing that a full clinical study report is published. This is the same document that companies must submit to regulators for approval of their medicine, and therefore contains a full account of how the clinical trial was conducted and what the results were.
“I also want to see financial penalties imposed on those that do not upload their results on time,” said Mrs Willmott. The law in the US requires all trial results to be uploaded within a year, but a 2012 audit found that 80% of trials had failed to comply. “If we are serious about openness in medicine then we have to levy fines on those not following the rules.”
Numerous academic studies have found that around half of all trials are never published, usually those with negative or disappointing results.
“For too long unflattering studies have gone undisclosed,” said Mrs Willmott. “It is vital that we know about negative outcomes, otherwise trials can be conducted repeatedly before it becomes public knowledge that they are ineffective or even dangerous.
“When a patient makes the decision to take part in a clinical trial, they do so to help advance medicine, to improve treatment for themselves and for those in a similar situation. They do not do it to help a particular company promote a particular drug.”
- Glenis Willmott’s full report can be found here: http://www.europarl.europa.eu/sides/getDoc.do?pubRef=-//EP//NONSGML%2BCOMPARL%2BPE-504.236%2B01%2BDOC%2BPDF%2BV0//EN
- The report will be voted on in the European Parliament’s Committee on Environment and Public Health before Mrs Willmott begins negotiations with EU governments.
- The original proposal from the European Commission can be found here: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd
- Research on problems with the US law can be found here: http://www.bmj.com/content/344/bmj.d7373
- Research about unpublished results can be found here: http://www.hta.ac.uk/fullmono/mon1408.pdf