Indian Council of Medical Research (ICMR) will be soon setting up a National Clinical Registry Network for bringing total transparency in clinical research information in the country. The Network, which demands mandatory registration of all clinical trials approved by the DCGI, will force the investigators to submit the entire clinical research (CR) data with the registry and the full data except those of confidential by a special agreement, will be in public domain.
The proposal is in the wake of a string of instances where the ADRs were found after granting of marketing approvals as certain critical clinical data were hidden by the trial sponsors and investigators.
Revealing the Registry Network initiative, Dr N K Ganguly, director general, ICMR, said that the registry would function as an independent body and would make it mandatory for the investigators to register the trial with them. Apart from this, the registry will have its own tracking system of clinical trials approved by the DCGI in the country, in coordination with all related institutions including drug control departments, hospitals ethical committees, ICMR etc., he informed.
"Once the trial is registered, the Network would start collecting the research data from time to time and will process and analyze the same with the help of medical experts and pharmacologists. The analyzed trial data will be available to public through internet. Though the entire data will be available with the Registry, depends on the confidential data agreement between the investigator and the Registry, only certain information would be kept confidential unless there is a need to divulge the same to public," Ganguly said.
ICMR chief said that the key objective of setting up the Registry is to keep the complete clinical trials data to the access of the authorities as well as the public to ensure the transparency on ethical practices and the safety profile of the drug molecule while the trials are on and also to disseminate the complete information on the risks and benefits of the drug molecule to the medical fraternity and patients.