EU Looks to Reform Clinical Trials

A law that would require researchers in the European Union (EU) to share clinical trial results—positive and negative—was approved by the Public Health Committee of the EU Parliament on January 22. The regulation of transparency is part of a larger overhaul of clinical trial rules intended to boost clinical research in the EU.

“For too long, unflattering studies on new medicines have gone undisclosed,” EU Parliament member Glenis Willmott, who has been shepherding the bill through the approval process, said in a statement. “It is vital we know about negative outcomes,” she continued, so trials that show medicines are ineffective—or even dangerous—become public knowledge. The law would require researchers to upload results to a public online database within a year of the close of a trial.

The full EU Parliament plans to debate and vote on the law in April. Most stakeholders expect it to be adopted, says Anastassia Negrouk, head of the International Regulatory and Intergroup Office at the European Organisation for Research and Treatment of Cancer, a Belguim-based nonprofit that sponsors cancer research.

Additional components of the proposed law are intended to streamline the clinical trial approval process and make the EU a more attractive place to conduct research. The total number of clinical trials in the EU dropped 25% percent between 2007 and 2011, from more than 5,000 to about 3,800, although multiple factors—not solely the complexity of the approval process—may be to blame, Willmott said.

Under the new law, a researcher conducting a clinical trial in multiple EU member states will electronically file only one application with the European Commission rather than one in each member state involved, as is currently stipulated. Applications have to be approved by each of the member states involved.

Streamlining clinical trials is particularly important for cancer researchers who run large international studies, says Negrouk. She adds that the emphasis on transparency points to a straightforward way for clinicians to share resources.

Under the new regulations, the data and materials collected as part of a clinical trial could be used by other researchers working on different research projects or trials, assuming researchers received the appropriate consent from patients at the start of the trial. If so, “someone can conduct further research on the material without subjecting the patients to additional risk,” says Negrouk.

Researchers in the United States may also be affected by the new laws, as international clinical trials regularly reach across the Atlantic. Under the existing law, a U.S. organization cannot sponsor a trial in Europe without a legal representative—someone who can represent the organization in legal proceedings—in Europe. Under the new regulations, that requirement is left up to the member states involved, which could complicate U.S.-led trials, Negrouk points out. A U.S. organization that sponsors an international trial involving EU countries may have to appoint legal representatives in each of the involved states.

“Trials led by major companies will not be affected because they all have somebody in Europe,” she explains, “but this provision could affect small biotech companies and researchers in academia.”