Clinical Trials in India Regulatory Issues

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1 Clinical Trials in India Regulatory Issues Prem Pais MD Dean & Professor of Medicine St. John s Medical College Head, Clinical Trials Division St. John s Institute of Population Health and Clinical Research Bangalore

2 St John s Medical College & Research Institute

3 Objectives of the talk Evolution of CT in India Regulatory procedures Requirement for registration IERB issues Insurance and compensation The elderly as a vulnerable group

4 Health Care in India An Imbalanced Picture Relatively well-developed health care services Over half a million doctors trained in Modern System of medicine; & another half a million doctors of Indian systems and homeopathy Out-migration of doctors Over 15,000 hospitals (estimates), 250 Medical Schools (Modern System) Medical tourism & corporate hospital business encouraged No universal access to health care 80% of health services in private sector Less than 10% covered under voluntary health insurance 75% of health care financed by out of pocket expenditure Cost of health care a major cause of poverty

5 Evolution of CT in India Small uncontrolled trials to satisfy regulatory requirements to market drugs already marketed abroad In 90s some multinationals set up independent research wing and included India in companies international trials CROs looked at India as area of large numbers, lower costs and good, English speaking doctors Academic trials in which sponsor is not from industry

6 World s Clinical Trials Status Source: - May 1, 2012

7 India: Clinical Trials Increased Nos. about 100 (2005) to about 2186 (2012) conducted in a few thousand hospitals CROs: few (1995) to over 70 (2005) & increasing CT business close to a billion US $ & increasing Low costs lower by 50% or more Patient pool Large numbers variety of disease conditions (prevalent in developing & developed countries) treatment naive patients (lack of universal health care)

8 Clinical trials in India: current scenario October 2006: India 8% of global patients in Phase 3 clinical trials* Funds**: 2004 US$285 m 2007 US$1000 m *The Hindu, Oct 11,2006 **McKinsy & Co

9 Booming Clinical Trial Market in India RNCOS Online Business Research 2007 CT market expected to grow at CAGR of 36%between Revenues of USD 546 million Biggest advantage availability of large pt pool. Recruitment 3 times faster than in US Major reason: large no of patients with unmet medical needs Trials enable them to access free medical care tests and drugs they would otherwise not be able to afford Salaries 10% of West

10 Clinical trials in India - a delicate line to tread DNA Thursday, January 5, 2012 What started as a rare reporting subject only a few years ago has become a frequent fixture for newspapers and magazines ethics in clinical trials in India. Unfortunately for the industry, most of the coverage focuses on the ill-effects of doing clinical trials on the Indian population. Examples abound of clinical trials by global companies in remote locations on gullible patients, leading to deaths or long-term serious adverse events. Though dramatized out of proportions by television channels, much of the information in public domain is correct. As a consequence, although the clinical trials industry has bright prospects, the edge is gradually getting blunted.

11 Regulation of Clinical Trials Standards and structures 2003 Acceptance of WTO patent regime 2005 Relaxation in Phase II to IV CTs Revised schedule Y of Indian D&C Act to guide drug development in India Ethical guidelines: Indian Council of Medical Research (ICMR) 1980; 2000 and Translates most international ethical standards to India but not legislated Institutional Ethics Committees (IECs): ICMR guidelines Procedures for establishment and functioning of ethics review - but not legislated

12 Regulatory Approvals Industry Sponsored RCT Drugs Controller General of India approval New procedure Review committee Academics who may have little CT experience Face to face meeting with sponsor Class A trials now deleted

13 Regulatory Approvals Academic Studies Academic studies with international collaboration require HMSC clearance May take 3 to 6 months Wholly Indian studies need only IERB/DCGI approval

14 Clinical trials registration Health ministry mandates registration of all clinical trials in India w.e.f 15 th June 2009 Site maintained by Indian Council for Medical Research Over 1115* trials currently registered on the site Trials searchable from WHO International Clinical Trials Registry Platform *source: Clinical Trials Registry of India

15 Ethical Approval Sites that have ethics committees must get approval from their own IERB DCGI specifies constitution of the IERB Sites that do not have IERB Set up their own Approval by another IERB Independent Ethics Committees (same area, new) Problems with high fees

16 Adverse Event Reporting All deaths must be reported to DCGI and IERB even if death is an endpoint All SAEs irrespective of cause must be reported to IERB

17 Institutional Ethics Committees (IECs) IECs: Main regulatory bodies Decentralised, and under control of institutions No independent authority for IEC oversight, financing From 2004, the ICMR started the NIH supported program for research bioethics training - inadequate to train members and investigators, need more investment No data on functioning of IECs, no reports Controversies about specific trials but no IEC made accountable IECs get legitimacy from the law, but do not work in collaboration with legal regulator

18 Financial disclosure Budget must clearly state Source of funds; foundation, industry etc Expenditures with justification Type of compensation if any to participants

19 Insurance and indemnity Clinical trials must have adequate insurance for study related injury Define Liability of different stakeholders Patient Information sheet should mention In case of study related injury or death, M/s (applicant) will provide complete medical care along with compensation for the injury or death Compensation to be decided by concerned IERB

20 Inclusion of elderly Geriatric patient allowed in phase II & III if the disease intended to be treated is characteristically a disease of aging; or the population to be treated is known to include substantial numbers of geriatric patients; or when there is specific reason to expect that conditions common in the elderly are likely to be encountered; or when the new drug is likely to alter the geriatric patient's response (with regard to safety or efficacy) compared with that of the non-geriatric patient