Newspaper- The Economic Times
Section- Policy
Page- 15
Date- July 21, 2011

Need of better regulation of clinical trials
21 Jul, 2011, 06.56AM IST, Riku Sarma & Manisha Singh,

In India, there have been no guidelines providing for uniform formats and procedures to be used by pharmaceutical companies and clinical research organisations (CRO) for reporting serious adverse events (SAE) in clinical trials. On May 12, 2011, through Draft Guidance on Reporting SAEs, the Central Drug Standard Control Organisation (CDSCO) aims to, inter alia, achieve such uniformity and completeness of data filed by companies and CROs for SAE reporting in clinical trials.

This nine-page draft guidance requires causality assessment by investigator and the medical monitor of sponsor or CRO to clearly mention whether the SAE is related or not related, and prohibits usage of situations such as unlikely, possibly, suspected, doubtful, etc. Further, it requires the sponsor or the CRO to provide details of compensations provided for injury or death and, in case no compensation is paid, reason for the same is required to be mentioned.

All SAEs occurring in clinical trials are to be reported within 14 calendar days to the Drug Controller General (India) (DCGI) as per Annexure I to the draft guidance that lays down the data elements for reporting SAEs. The draft guidance is also categorical that in case of study-related injury or death, complete medical care as well as compensation for the injury or death is to be provided.

This move of CDSCO, which may have perhaps been precipitated because of parliamentary pressure, is undoubtedly a welcome move on this emerging issue and will give a new direction to clarify SAEs and the degree of liability and responsibility of sponsors and CROs towards patients who suffer from such SAEs. As ofnow, the good clinical practices (GCP) - applicable to clinical trials conducted in the country - provides that patients who suffer physical injury as a result of their participation in the clinical trial are entitled to financial or other assistance to compensate them equitably for any temporary or permanent impairment or disability.

In case of death of such patients, their dependents are entitled to material compensation. However, difficulty arises as the Indian GCP does not relate, in clear terms, the causality of the injury suffered by a patient to the compensation. This is one of the major reasons why compensation in most cases of injuries or deaths arising as result of participation in clinical trials, have been delayed. Although this lack of clarity in the Indian GCP has been addressed in this draft guidance to some extent, a number of issues that the government, the sponsors or the CROs may be faced with relating to SAEs during clinical trials still remain to be addressed.


For example, in case of study-related injury and deaths, there is no guideline in the country like that in road accident cases where method for computing compensation has been provided for - even this draft guidance is silent on this important aspect. The CDSCO may consider addressing this issue of quantum of compensation while finalising this draft guidance taking into account factors such as age, socioeconomic background and, most importantly, medical history and life expectancy of the deceased.

The CDSCO may also consider setting up a structure that may enable the investigator, sponsor, CRO or medical monitor to resolve a difference of (scientific) opinion or disagreement that may arise between them with regard to causality assessment, quantum of compensation, etc. That such disagreements may arise have been anticipated in the past. The Indian Council of Medical Research (ICMR), in its Ethical Guidelines for Biomedical Research on Human Participations, recommended formation of an arbitration committee or appellate authority to be set up by an institution to decide on compensation on a case-by-case basis.

Similar recommendations were made in the November 2008 draft Guidelines for Compensation to Participants for Research-Related Injury in India (GCPFRI), prepared by the ICMR, Forum for Ethics Review Committees in India (FERCI) and the Indian Society for Clinical Research (ISCR). The draft GCPFRI provided for appointment of arbitration committee by the institution consisting of one person nominated by each party in conflict, and a chairperson nominated by the selected arbitrators.

Clearly, current guidelines on clinical trials in the country suffer from inconsistencies and ambiguities. Though seemingly minor, these inconsistencies have resulted in delays in payment of compensation to the injured or dependents of the deceased, and led to recent controversies around these issues. Consideration of these evolving issues in a transparent manner will help ironing out ambiguities and inconsistencies and would bring about clarity regarding the responsibility of the sponsor or the CRO in case of SAEs in clinical trials including compensation.

(R Sarma is partner and M Singh issenior associate at Corporate Law Group)