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Serious adverse event occurs to trial subject during clinical trial


Wednesday, September 30, 2020, 08:00 Hrs  [IST]

How does an Ethics Committee review and assess a serious adverse event (SAE)? Are 122DD provisions valid post-2019?
Dr Sireesha

Since March 2019, New Drugs and Clinical Rules are the rules governing all aspects of clinical trial conduct. All earlier rules and amendments concerning SAE and compensation are included in New Drugs and Clinical Rules 2019 in different chapters/schedules. Please see the relevant info given below:
•    Rule 11. Functions of Ethics Committee (iv) where any serious adverse event occurs to a trial subject or to study subject during clinical trial or bioavailability or bioequivalence study, the Ethics Committee shall analyse the relevant documents pertaining to such event and forward its report to the Central Licensing Authority and comply with the provisions of Chapter VI.
•    Rule 25. Conditions of permission for conduct of clinical trial (x) any report of serious adverse event occurring during clinical trial to a subject of clinical trial, shall, after due analysis, be forwarded to the Central Licensing Authority, the chairperson of the Ethics Committee and the institute where the trial has been conducted within fourteen days of its occurrence as per Table 5 of the Third Schedule and in compliance with the procedures as specified in Chapter VI.
•    Rule 39. Compensation in case of injury or death in clinical trial or bioavailability or bioequivalence study of new drug or investigational new drug.
•    Rule 40. Medical management in clinical trial or bioavailability and bioequivalence study of new drug or investigational new drug.(1) Where an injury occurs to any subject during clinical trial or bioavailability and bioequivalence study of a new drug or an investigational new drug, the sponsor, shall provide free medical management to such subject as long as required as per the opinion of investigator or till such time it is established that the injury is not related to the clinical trial or bioavailability or bioequivalence study, as the case may be, whichever is earlier.
•    Rule 41. Consideration of injury or death or permanent disability to be related to clinical trial or bioavailability and bioequivalence study. Any injury or death or permanent disability of a trial subject occurring during clinical trial or bioavailability or bioequivalence study due to any of the following reasons shall be considered as clinical trial or bioavailability or bioequivalence study related injury or death or permanent disability, namely:
(a) adverse effect of the investigational product.
(b) violation of the approved protocol, scientific misconduct, or negligence by the sponsor or his representative or the investigator leading to serious adverse event.
(c) failure of investigational product to provide intended therapeutic effect where, the required standard care or rescue medication, though available, was not provided to the subject as per clinical trial protocol.
(d) not providing the required standard care, though available to the subject as per clinical trial protocol in the placebo-controlled trial.
(e) adverse effects due to concomitant medication excluding standard care, necessitated as part of the approved protocol.
(f) adverse effect on a child in-utero because of the participation of the parent in the clinical trial.
(g) any clinical trial procedures involved in the study leading to serious adverse event.

•    Rule 42. Procedure for compensation in case of injury or death during clinical trial, bioavailability and bioequivalence study.
•    Third Schedule Table 5 data elements for reporting serious adverse events occurring in a clinical trial or Bioavailability or Bioequivalence Study.
•    Seventh Schedule formulate to determine the quantum of compensation in the cases of clinical trial related injury or death.


Can a literate family member of an illiterate clinical trial participant sign as an impartial witness?
Ravi Gaware
Ideally, the impartial witness should be a third party who does not have any relationship with the clinical trial participant or with the clinical trial investigation site. European Patients' Academy considers a non-research member of staff or the patient’s relative as impartial witness. ICMR 2017 Guidelines 5.4.3 discourages use of relative of the participant as impartial literate witness. However, ICMR guidance 2017 is not applicable to clinical trials of new drugs, as defined by New Drugs and Clinicals Trials Rules 2019.

U.S. Department of Health & Human Service Secretary’s advisory committee on human research protections (SACHRP), whilst commenting on the FDA 2014 Draft Guidance on  Informed Consent supported the interpretation that an adult family member can serve as a witness in this role, where there is no reasonable concern that the proposed witness is not acting in the best interest of the individual.

In practice, it would be difficult to find a neutral third party in a busy hospital who would be willing to act as an impartial witness, participate in audio-visual recording, and spend time listening to the consent discussions. It would also be difficult to establish that a non-research member of hospital staff cannot be unfairly influenced by people involved with the trial. Hence, this practice is not in line with spirit of GCP and cannot safeguard rights of a poor illiterate person. Legally acceptable representative (LAR) or a family member is not involved in the study, and is not a site person, and cannot be influenced by those involved in the trial from hospital site. He/she could be influenced by the clinical trial participant. But LAR or a family member would usually safeguard rights of a poor illiterate person. Hence, LAR or a family member would be the best option as an impartial witness in Indian situation.

Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:arun_dbhatt@hotmail.com

 

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