Article Text
Abstract
Objectives: To review the performance of research ethics committees (RECs) in Spain in assessing multicentre clinical trial (MCT) drug protocols, and to evaluate if they would comply with the requirements of the new EU Directive to be implemented by May 2004.
Design and setting: Prospective study of applications of MCT submitted to RECs.
Main measurements: Protocol related features and evaluation process dynamics.
Results: 187 applications (24 protocols, 18 study drugs) to be performed in 114 centres, were reviewed by 62 RECs. RECs had a median number of 14 members, of which three were lay members. All applications were approved except four which were however approved by the other RECs involved. The median times from submission to approval and from submission to reception at the sponsor’s offices were 48 and 62 days, respectively. In 55% (101/183) of all applications approved, 41 RECs raised 307 queries, 40% of these were protocol related issues, and 38% related to the patients’ information sheets. RECs charging an evaluation fee in advance and applications with no queries raised were statistically significantly associated with shorter evaluation times. However, there is a gap of at least 1.5 weeks between the date of the meeting and the reception of the approval letter in the sponsor’s office.
Conclusions: Evaluating MCT protocols by RECs is a time consuming process. Needing 1.5 weeks for communicating the decision taken by RECs to the sponsor suggests serious administrative shortcomings within most RECs. By significantly reducing the time for communication of their decisions, the majority of RECs would comply with the Directive requirement of a maximum 60 day period for the assessment of MCT.
- MCT, multicentre clinical trial
- PIS, patient information sheet
- REC, research ethics committee
- SMA, Spanish Medicines Agency
- research ethics committees
- approval process
- times
- clinical multicentre trials
- drugs
- Spain
Statistics from Altmetric.com
Footnotes
Read the full text or download the PDF:
Other content recommended for you
- Legislative regulation and ethical governance of medical research in different European Union countries
- Impact of recent legislative bills regarding clinical research on Italian ethics committee activity
- Implementation of the EU clinical trial regulation transforms the ethics committee systems and endangers ethical standards
- Importance and role of independent data monitoring committees (IDMCs) in oncology clinical trials
- Research ethics committees in Europe: implementing the directive, respecting diversity
- Time required to start multicentre clinical trials within the Italian Medicine Agency programme of support for independent research
- Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries
- Opening research sites in multicentre clinical trials within the UK: a detailed analysis of delays
- Current models, challenges and best practices for work conducted between European academic cooperative groups and industry
- Harmonisation of ethics committees' practice in 10 European countries