Aiming to ensure protection of rights, safety and well beings of trial subjects and authenticity of the data generated, the CDSCO will soon launch an IT-enabled system for online submission of various information on clinical trials which will streamline the process of approval, maintaining comprehensive database and monitoring of clinical trials in the country.
Senior officials in CDSCO said that looking at the current regulatory environment of clinical trial in India, it is important that all information related to four major domains of clinical trial (CT) such as sponsor/CRO; investigator; ethics committee (EC); and patient will be captured through online in an organised manner.
According to the CDSCO proposal, in order to capture the exact information, all the sponsors/CROs, investigators and ethics committees are required to put the information in a common repository related to a particular CT which is updated by the stakeholders on day to day basis. It is proposed to have an 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, etc.
The additional information will include 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 randomised, controlled which is open, single or double blind, parallel or cross over design.
The information regarding the investigational sites includes the complete details of the investigators, correspondence addresses of the sites, contact details and email address of the Investigators. The detail regarding the team of the investigator also needs to be disclosed on this system. If the trial is multi-country the details regarding the countries participating in the trial and number of sites and patients expected from those countries should also be disclosed.
The information should also include details of targeted patient population planned to be enrolled in the trial or whether any high risk or vulnerable patients are included in the trial. This includes infants, children, women of childbearing potential, lactating women, etc. The complete details of the ECs responsible for the oversight of the trial should be given. Once this information regarding particular trial is put in the system, it would generate a Unique Identification Number (UIN) which is specific to a particular clinical trial.
The CDSCO will keep track of all information in the system with the UIN. Once the UIN is granted to a sponsor/applicant, they need to share the same with investigators and the ECs, so that they can maintain the database on day to day basis.
The CDSCO has invited suggestions/comments from stakeholders within three weeks.