Calls from medical researchers to make clinical trials less bureaucratic and more transparent came closer to reality today as legislation to simplify application procedures passed the first hurdle in the European Parliament.
The changes proposed by Labour MEP Glenis Willmott, the author of the legislative report, are expected to give a massive boost to the British medical research industry.
The report, which was given the green light from fellow MEPs in the European Parliament’s public health committee, would create a publicly accessible EU database, where all trials must be registered and their main findings reported within a year.
Mrs Willmott was also successful in demanding full “Clinical Study Reports” to be published once a new medicine comes to the market, and fines to be imposed if these transparency measures are not met.
Speaking after the vote, Glenis Willmott said: “Whilst strengthening transparency measures, we intend to simplify the rules to encourage more European trials, not just by drug companies but also by medical research charities and academic institutions. Better and more transparent trials will hopefully lead to new and improved treatments for many illnesses. Another important step will be making it easier to conduct cross-border trials. In the case of rare diseases this cooperation is vital.”
In regards to the issue of transparency Mrs Willmott also made it clear that today’s vote would have a significant impact, on opening up the opaque nature of clinical trials saying;
“We need to know the outcome of all clinical trials, whether they were successful or not. A clinical trial is not a marketing tool but an assessment of a drug’s safety and effectiveness. In the interest of public trust in medicine and good science we need access to detailed summaries of results and, when a new drug is authorised, Clinical Study Reports.
“Negative results are crucial to avoid the repetition of something that does not work, or may be dangerous.
The proposals will also lead to lower costs for companies and researchers running clinical trials.
“The Parliament has also supported proposals to greatly reduce the astronomical insurance costs for clinical trials. When governments and the EU give out medical research grants, a lot of the money is going straight to insurance companies, so it makes sense for the state to insure the trial themselves through a national indemnification system.” added Mrs Willmott