After 10 years of dwindling interest from medical researchers, Europe is considering revising its rules on clinical trials. The European Commission is proposing a revision to the Clinical Trials Directive, and CRO groups have praised the idea.
John Dalli, the EU's health commissioner, would like to see a centralized application process for multi-country trials, sparing researchers from enduring the bureaucracies of each country involved in a study, Nature reports. Furthermore, the commission wants to institute risk-based regulations, changing depending on the trial. For instance, under the current directive, trials of already-approved treatments go through the same hurdles as those of in-development drugs, according to Nature. Instead, the proposed changes would create a sliding scale of obligations for studies.
But perhaps the most important change would affect enforceability. The current directive is just that: a set of guidelines that member states can adopt as they see fit. The new proposal is to pass the revisions as regulations instead, making adherence mandatory for each country in the union.
Next, the proposed changes will go before the EU's Parliament and Council of Ministers for approval.
The idea is music to the ears of CROs looking to do business in Europe, and trade association ACRO lauded the move as a step in the right direction for the EU. "ACRO is especially pleased that the commission has followed our recommendations regarding the coordinated assessment of clinical trials, streamlined reporting and increased transparency," Executive Director Doug Peddicord said in a statement.
- here's the EU proposal (PDF)
- read the Nature report
- check out ACRO's statement