- Quality and Safety: Medicines > Quality Assurance
- Quality and Safety: Medicines > Safety and Efficacy
(1995; 36 pages) [French] [Spanish]
13. CONSIDERATIONS FOR MULTICENTRE TRIALS
Because a multicentre trial is conducted simultaneously by several investigators at different sites following the same protocol, some special administrative arrangements are normally needed. Ideally, the trial should begin and end simultaneously at all sites.
A number of aspects are rendered more complex in multi-centre trials, such as:
• the elaboration, discussion and written acceptance of the protocol and its annexes by all investigators;
• the submission of the proposed protocol or protocol amendments to the ethics committee(s), and the number of committees to be consulted;
• the organization of initial and intermediary meetings of parties involved in the trial;
• implementation of the trial;
• the procedures used for the randomization of trial subjects;
• ensuring that the quality of the product is maintained during distribution and storage in different locations;
• the training of investigators to follow the same protocol;
• standardization of methods for evaluating and analysing laboratory and diagnostic data (e.g. establishment of an external quality control system for laboratory assays);
• control of adherence to the protocol, including measures to terminate participation of trial sites if necessary;
• the role of the monitor(s);
• centralized data management and analysis;
• drafting of the final report and clearances required;
• publication of the trial results.
A multicentre trial therefore may require a special administrative system, the scale of which will depend on the number of trial sites involved, study end-points and knowledge of the investigational pharmaceutical product. One or several committees may be set up for this purpose or the necessary functions may be performed by one or more designated person(s). The functions, responsibilities and mandate of the committee(s) or person(s) should be described in the trial protocol, as should the procedure for nomination.
For example, a committee or an individual could be responsible for overseeing the initiation overall performance of the trial. Similarly, a second committee or person could be appointed to provide advice on policy matters and data collection. A third committee or person could be made responsible to the accuracy and verification of the data obtained. It should be stated in the protocol under what circumstances and how this committee or person can break the trial code. Collaboration between these committee(s) or person(s) is necessary.
A coordinating committee could also be set up or a coordinator appointed with responsibility for the control of the performance and progress of the trial and maintaining contacts with the drug regulatory authorities and ethics committees.
These administrative arrangements will provide adequate assurance that the study will be planned and conducted according to generally accepted scientific principles and Good Clinical Practice.