(29th July, 2014); Looking at the current regulatory environment of clinical trial in India, it is important that all information related to 4 major domains i.e, Sponsor/ CRO, Investigator, Ethics Committee, Patient of clinical trials are captured through online in an organized manner. Hence, for ensuring transparency and faster dissemination of information about clinical trials, health ministry may start information technology (IT) enabled platform. The recommendation of such platform is provided by Prof. Ranjit Roy Chaudhary Committee.
Initially, CDSCO proposes to create an IT enabled system for online submission of various information on clinical trials to streamline the process of approval, maintaining comprehensive database and monitoring of clinical trials for ensuring the protection of rights, safety and well beings of trial subjects and authenticity of the data generated.
In this, IT enabled system where a Sponsor /applicant needs to submit the information related to clinical trial which pertains to full title of the trial, sponsor’s protocol code number, name or abbreviated title of the trial where available.They also have to fill up details for the identification of the Sponsor, local applicant identification, brief description of the investigational product, information on the use of placebo, information regarding the use of the comparator, site/ warehouse responsible for the release of the investigational medicinal product, brief summary of the protocol which includes the medical condition in which the trial is proposed, information regarding the disease prevalence in India, whether the disease is a rare disease, main objective of the trial, principal inclusion and exclusion criteria and the endpoint of the study. This information should also include the scope of the trial, whether the trial is diagnostic, prophylactic, therapeutic, safety, efficacy, pharmacokinetic, pharmacodynamic, bioequivalence, dose response, pharmacogenomic, or other .
Applicant should also provide information regarding the trial design, which includes randomized, controlled which is open, single or double blind, parallel or cross over design.
In brief, they have to provide full plan of trial including Ethics Committees details responsible for the oversight of the trial. After filling full details, it will generate UID (unique identification number) for that trial. And through this UID health ministry can get complete idea on clinical studies.
The main advantage of this system will, if any patient is enrolled in a clinical trial, the Investigator or the site should disclose the details of enrolled patients including name, address, annual income, age, sex, qualification, name of nominee etc. of the trial subject, details of Serious Adverse Events (SAEs), if any, observed while the subject is on the trial and the outcome of the SAEs . In case clinical trial related SAEs, the details of the compensation paid/ claimed also needs to be captured.
