Though the Union health ministry has released new draft clinical trial guidelines for stakeholders review, experts have however raised concern over certain challenges in terms of compensation related ethical issues of trial subjects during a clinical trial which is not in any way related to causality
The contentious issue is centred around the draft guideline that compensation to be provided to all trial subjects irrespective of causality during the medical management of a specific medical condition or disorder for a clinical study.
“It is like going back to the same point about that being an inducement for participation and not an ethical way to do. There is also a need to determine whether India really has ethics committees which can work out compensation to trial subjects for medical management during a clinical study related to causality,” said an expert associated with the development.
It is like if a clinical study related to dermatological condition, the patient suffers a heart attack, how will the event be related to the medical condition and what would be the quantum of compensation borne by the sponsor to be justified as is a case in point which need to be addressed, the expert added.
Causality or related assessment implies determination of whether there is a reasonable possibility that the product is causally related to the adverse event. Causality assessment includes evaluation of temporal relationships, association with or lack of association with underlying disease, presence or absence of a more likely cause, and biologic plausibility.
Health ministry has also released new draft clinical trial guidelines on audio-visual recording during a clinical trial for stakeholders review. These draft guidelines are aimed at seeking recommendations for streamlining audio-visual recording of informed consent process during clinical trials in the country.
The draft guidelines talks about information for prospective study subjects, principle of privacy and confidentiality, consent of the subjects for audio visual recording, procedure of recording, quality of recording, storage and archival of audio-visual recording during a clinical trial.
As per the gazette notification dated July 31, 2015, it has been mandated that an audio- video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.
As per the Schedule Y, in all trials, a freely given, informed, written consent is to be obtained from each study subject. The investigator must provide information about the study verbally as well as using a patient information sheet, in a language that is non-technical and understandable by the study subject.
The draft Clinical Trials Rules, 2018 applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. It will come in to force after its final publication in the Official Gazette. This will be under Part XA and Schedule Y of the Drugs and Cosmetics Rules, 1945, and section 12 and 33 of the Drugs and Cosmetics Act, 1940.
The new regulations clearly defines features of an academic study, role of central licensing authority, trial protocol, biomedical and health research.
Further it has detailed about clinical trial in relation to a new drug or investigational new drug in human subjects to generate data for discovering or verifying its pharmacological interactions including pharmacodynamics, pharmacokinetic and adverse effects. The objective is to determine the safety, efficacy or tolerance of new drugs.