To issue a permit for clinical trials, it is necessary to obtain approval from a number of expert bodies - the Commission on Bioethics, the National Medicines Regulator ... often the applicant has to apply separately to these expert bodies.
How necessary and effective are single window mechanisms for authorizing clinical trials?
Hi,
Clinical trials form one of their agendas but they are lot many things which are also priorities. I don't think that anywhere a single-window system exists. clinical trials are of diverse nature and permissions have to be obtained from several departments.
In India, we do have a single-window named the SUGAM portal (launched in 2016) for filing applications for various services pertaining to regulatory clinical trials. The services offered by the SUGAM include online submissions, review, and grant of NOC/permission.
You can see the portal statistics from its date of inception in the below link:
https://cdscoonline.gov.in/CDSCO/dashboard_statistics
In the context of "authorizing clinical trials", I personally feel that the single-window mechanism is much helpful in streamlining the activities.
The first checkpoint is regarding the necessity of the trial (particularly for drug/product registration), second- it harmonizes the requirement for all similar applications.
Third- it could expedite as well as omit unnecessary/extra processes.
In India- we take DCGI approval for regulatory clinical trials followed by Ethics Committee approvals from respective trial sites. DCGI approval covers the Subject Expert Committee (SEC) review.
Non-regulatory trials are under the provision of the Biomedical Health and Research committee and are mostly overlooked by Ethics Committee(s).
Only for rDNA/gene therapy like niche areas, additional approval is required.