The Central Drugs Standard Control Organisation (CDSCO) issued the guidance earlier this month in an effort to ensure that all unexpected serious adverse events (SAE), those unrelated to underlying medical conditions, that occur during trials are reported within 14 days.
In a letter to the CDSCO, Association of Clinical Research Organisations (ACRO) executive director Douglas Peddicord said although the guidance distinguishes between trial-related SAEs and those that are not, an arbitration mechanism is needed to settle disputed cases.
“Recognizing that such either-or determination can be difficult, we believe that a procedure should be in place for determining the question of causality on the occasion when the investigator and the sponsor or CRO medical monitor disagree.
Peddicord’s suggestion is that, in such circumstances, a CDSCO approved panel made up of the investigator, a representative of the sponsor or CRO, a member of the trial’s ethics committee and two independent medical professionals make the final determination.
“The expert panel might evaluate an injury or death adjudged ‘related’ by the investigator and determine that, in fact, the injury or death resulted from medical negligence by a physician or hospital employee and not from the test biomedical product or device and therefore determine that the injury or death is ‘not related’.”
Peddicord also wants a similar mechanism to decide what constitutes ‘complete medical care’ and ‘fair monetary compensation’ if there is a disagreement between a patient injured by a trial-related unexpected SAE and the investigator, sponsor or CRO.
He suggests an expert panel based on the Arbitration Committee proposed by the Indian Society for Clinical Research in their draft guidelines for the compensation to participants for research related injury would be appropriate.
“In case of a dispute or difference between the involved parties (research participant / research participant’s legal heir/lawful guardian in case of death, Sponsor, Investigator) regarding the amount of compensation, an Arbitration Committee should be appointed by the Institution consisting of one person nominated by each party in conflict, and a chairperson nominated by the selected arbitrators.”
“Again we would suggest that at least two the members of the expert panel be individuals with expertise in medicine and law not previously affiliated with the clinical trial or any of the parties.”
Peddicord concludes by saying that: “We look forward to working with the Government of India to develop Expert Panels and Appellate processes that will operate transparently and will have the requisite expertise to adjudicate sometimes difficult questions of causality and the calculation of fair compensation.”