Deaths During Clinical Trials

Drugs & Cosmetics Act, 1940 contains enabling provisions for regulating and ensuring quality, safety and efficacy of drugs. The Act, therefore, contains inherent enabling powers for regulating the clinical trials. Accordingly, under the inherent plenary powers vested in the Act, necessary rules, procedures and guidelines have been framed under the Drugs and Cosmetics Rules, 1945. Regulatory provisions for clinical trials in the country are prescribed under Rule-122DA, 122DAA, 122E and Schedule-Y to the Drug and Cosmetics Rules, 1945. The said Rules also provide specific Application Form and relevant documents required for seeking permission to conduct clinical trials in India. Schedule Y also mandates the clinical trial to be conducted as per Good Clinical Practices (GCP) Guidelines issued by Central Drugs Standard Control Organisation (CDSCO). Clinical trials can be initiated only after the approval of CDSCO and respective Ethics Committee.  In all trials, a freely given informed written consent is required to be obtained from  the persons   participating in the study  trial.   The Serious Adverse Events (SAEs) of deaths may occur during  clinical trials due to various reasons. These deaths could be due to life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure / stroke and other serious diseases. They could also be due to the side-effects of the drugs or their administration to critically or terminally ill patients. Such deaths are investigated to arrive at the causal relationship, if any. As per available data, the number of Serious Adverse Events of deaths in clinical trials reported during 2011 were 438.   But SAEs of death due to clinical trials were 16.

Out of 438 deaths approximately 55% are in clinical trials conducted by foreign Pharmaceutical companies and rest are in clinical trials conducted by Clinical Research Organizations (CROs), domestic pharma Companies etc.

The following concrete steps have been taken to strengthen the approval procedures, monitoring mechanism for clinical trials as well to ensure that safety, rights and well-being of clinical trial subjects are protected:

(1) 12 New Drug Advisory Committees (NDAC) consisting of leading experts from the government medical colleges, institutes from all over the country have been constituted to advise CDSCO in matters related to approval of clinical trials and new drugs.

(2) Applications of Investigational New Drugs (IND) ; i.e, New Drug Substances which have never earlier been used in human beings, are evaluated by the IND committee, chaired by the Director General, Indian Council of Medical Research.

(3) Registration of clinical trial in ICMR registry at www.ctri.in has been made mandatory since 15.6.2009.

(4) Every approval / permission for conducting clinical trials now includes a condition that in case of study related injury or death, applicant will provide complete medical care as well as compensation for the injury or death and statement to this effect would be incorporated in the informed consent form.

(5) Guidelines for conducting inspection of Clinical Trial sites and sponsor /Clinical Research Organizations (CROs) have been prepared and posted on CDSCO website.

(6) Draft rules have been notified to provide for the following:

(i) Medical treatment and financial compensation to the trial subjects in case of trial related      injury or death;


(ii) Procedure for payment of financial compensation;

(iii) Enhancement of responsibilities of Ethics Committee (EC), Sponsor & Investigator to ensure that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths and such information is provided to the Drugs Controller General (India) [DCG(I)].


(iv) Amendment of the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects.


(7) Draft rules have been notified to incorporate Rules to have authority for clinical trials inspections by CDSCO and to take administrative actions like restriction on investigators/ sponsors / CROs from conducting future clinical trials in case of non-compliance.

(8) Draft rules have been notified to incorporate Rules and Schedule Y-1 specifying requirements and guidelines for registration of Ethics Committee.

This information was given by Minister for Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Rajya Sabha today.

Source:pib

BN/HB/AS