Though the Union health ministry has released new draft clinical trial guidelines for stakeholders review, specialists have however raised concern over certain challenges regarding compensation related ethical issues of trial subjects during a clinical trial which isn’t in any way related with causality.
The contentious issue is revolved around the draft guideline that compensation to be given to all trial subjects regardless of causality during the medicinal management of a particular medical condition or disorder for a clinical study.
“It stimulates going back to the same point of participation and not an ethical way to do. There is also a need to determine if India really has ethics committees which can work out compensation to trial subjects for medicinal administration during a clinical report related to causality,” said a specialist related with the development.
It resembles if a clinical study related with the dermatological condition, the patient suffers a heart attack, how will the event be related with the medicinal condition and what might be the quantum of compensation borne by the sponsor to be justified similar to a valid example which should be tended to, the expert included.
Causality or related evaluation infers determination of whether there is a reasonable probability that the product is causally related to the adverse event. Causality assessment includes assessment of temporal relationships, association with or lack of association with underlying disease, presence or absence of a more likely cause, and biologic plausibility.
During a clinical trial for stakeholders audit, the health ministry has also released new draft clinical trial guidelines on the audio-visual recording. These draft guidelines are aimed at seeking suggestions for streamlining audio-visual recording of informed consent process during clinical trials in the country.
The draft guidelines discuss data for prospective study subjects, a principle of privacy and confidentiality, consent of the subjects for audiovisual recording, the procedure of recording, quality of the recording, storage and archival of audio-visual recording during a clinical trial.
According to the gazette notice dated July 31, 2015, it has been ordered 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 giving data to the subject and his understanding on such consent, might be kept up by the investigator for record.
According to the Schedule Y, in all trials, a freely given, informed, written consent is to be acquired from each study subject. The investigator must give data about the study verbally and in addition utilizing 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 utilize, clinical trial, bioequivalence study, bioavailability study, and Ethics Committee.
It will come in to compel after its last 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 characterize features of an academic study, the role of central licensing authority, trial protocol, biomedical and health research.
Further, it has detailed about a clinical trial in connection to a new drug or investigational new drug in human subjects to generate data for finding or verifying its pharmacological interactions including pharmacodynamics, pharmacokinetic and adverse effects. The goal is to determine the safety, viability or tolerance of new drugs.