Seminar; Present Status of Clinical Trials in India

Information about Seminar; Present Status of Clinical Trials in India

Published on July 14, 2014

Author: dipanshusur



PowerPoint Presentation: Present Status of Clinical Trials in India: The Wind is Blowing; Unfolding The Truth Dipanshu Sur PowerPoint Presentation: Dipanshu Sur 2 What Clinical Trials Are? “Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product(s), and/or to identify any adverse reactions to an investigational product(s), and/or to study absorption, distribution, metabolism, and excretion of an investigational product(s) with the object of ascertaining its safety and/or efficacy” . (according ICH-GCP 1.12) It represents a bridge from early stage of drug development to commercialization. This bridge can’t be bypassed and is long & expensive to cross. Systemic Clinical Study of: To Discover of Verify: New drug Medical devices Biologics Physiological therapies Other intervention Performed on HUMAN VOLUNTEERS 7/14/2014 Pharmacokenetics (what happens to it) Pharmacodynamics (how it works) Therapeutic effect (efficacy) Adverse reaction (safety) PowerPoint Presentation: 7/14/2014 3 Dipanshu Sur Clinical Trials in Nutshell? PowerPoint Presentation: 7/14/2014 4 Dipanshu Sur Overview of Clinical Trials Phases PowerPoint Presentation: 7/14/2014 5 Dipanshu Sur World’s Clinical Trials Status Region Name Number of Studies World 86860 India 1875 Africa 1896 Central America 1308 East Asia 5688 Japan 1422 Europe 21101 Middle East 3130 Canada 6859 Mexico 1130 United States 45944 North Asia 1497 Pacifica 2634 South America 2637 Southeast Asia 1511 PowerPoint Presentation: 7/14/2014 6 Dipanshu Sur C linical Trials Status in India PowerPoint Presentation: 7/14/2014 7 Dipanshu Sur Clinical Trials Market Value in India Clinical trials in developing countries like India are exploding. It is experienced over 86 % growth during 2006-2008. According to the Associated Chambers of Commerce and Industry , an influential national industry association, India is set to achieved clinical trials business valued at approximately US$ 1 billion by 2010. Current market worth US$ 1.5 billion. India is now the subcontinent one of the world’s most preferred destinations for clinical trials. “ Booming Clinical Trials Market in India” PowerPoint Presentation: 7/14/2014 8 Dipanshu Sur Global Clinical Research Size $40 billion Indian Market Size in 2005-06 $200 million Market Size in 2010 $600 million 2014-15 Projected Industry Spending on CRO Services and Investigator Grants $2 billion By 2015 – 15% of Global Trials will shift to India Number of CROs - current 100 Number of MNC & Indian Pharmacos in Clinical Research 70 Clinical Research Market Growth (Annual) 40% Full time & Site Staff Required in 2014-15 50,000 New Trials Approved by Regulator 750/year Patients / Subjects Required in 2012 350,000 PowerPoint Presentation: 7/14/2014 9 Dipanshu Sur Percent of Global Trials in India PowerPoint Presentation: 7/14/2014 10 Dipanshu Sur The Facts Behind Clinical Trial Boom in India One of the biggest advantages of conducting clinical trials in India is the availability of a large patient pool that can be recruited at much shorter time then it takes to recruit patients in the west. Tax incentive to CROs. Indian clinical trials market is expected to grow at a CAGR of nearly 36% between 2006 and 2011 to register revenues worth US$ 546 Million in future. India by 2015 will be conducting more than 15% of the total global clinical trials. India becomes a more obvious choice because this is home to over 16,000 hospitals and 500,000 doctors , making it an ideal country, in which to conduct clinical trials. India presently lacks in GCP trained investigators (which are less than 1000). Their demand is projected to reach up to 8000 by 2014. India does not provide “Data Exclusivity” in clinical trials unlike the US and EU members. The salaries of a clinical data specialist and medical writer in India are around 15 % and 9 % less respectively in comparison to US. The clinical trials market growth will drive to the growth of diagnostics and pathology industry in India. According to the Drugs Controller General of India (DCGI), India will be a preferred site for clinical trials because, in addition to its medical infrastructure and trained, English speaking human power. It has a large, diverse and treatment-naive (not exposed to any form of treatment) population with six out of the seven genetic varieties of the human race . Huge patient base with diversity of diseases , at risk from diseases of poverty and underdevelopment as well as the so called life style diseases. Clinical trials in India are economic . Drug companies can save up to two - third of overall cost of conducting trials in India compared to the west. English-speaking technical workforce, Good IT infrastructure, low infrastructure costs, which can reduce expenditures for clinical trials by as much as 60 percent . PowerPoint Presentation: 7/14/2014 11 Dipanshu Sur Well Known Trial Conduction Sites in India Central Drug Research Institute (CDRI) Chattar Manzil Palace, Lucknow – 226001, Uttar Pradesh Centre for Cellular & Molecular Biology (CCMB) Hyderabad – 500007, Andhra Pradesh Indian Institute of Chemical Biology (IICB) Calcutta – 700032, West Bengal Institute of Microbial Technology (IMT) Chandigarh - 160036 Quintiles Spectral Limited Ahmadabad 380 015, Gujarat Specialty Ranbaxy Limited Mumbai - 400 093, Maharashtra Metropolis Health Services (India) Pvt. Ltd. Mumbai - 400 030, Maharashtra   PowerPoint Presentation: 7/14/2014 12 Dipanshu Sur Although the number of new trials registered in India in  2012 declined, the market will continue to grow steadily •Total number of trials registered in India till  date is 1875 •Number of new trials registered in India in  2011 had sharply declined from the number of  trials registered in 2010 •However, the market is not expected to be  negatively impacted by the lower number of  new trials registered in 2011 At present 513 clinical trial studies are being  conducted in India which is far greater than the  331 studies being conducted in 2010 and 181  studies being conducted in 2009 Since trials for a single drug itself may take several  years, the market will continue to exhibit steady  growth even if the number of new trials  registered declines in a particular year New Trials Registered Number of Trials Registered Each Year 0 100 400 300 200 2011 E 2010 D 2009 C 2011 B 2007 A Trials According to Therapeutic Areas A% B% C% E% F% Others CVD Cancer CNS Infectious Diseases Diabetes Cancer, CNS and infectious diseases are the  most popular therapeutic areas for clinical  trials, followed by diabetes and CVD D% PowerPoint Presentation: 7/14/2014 13 Dipanshu Sur Clinical Trial Indications Assess the safety and effectiveness of a new medication or device on a specific kind of patient. Assess the safety and effectiveness of a different dose of a medication than is commonly used (e.g., 10 mg dose instead of 5 mg dose). Assess the safety and effectiveness of an already marketed medication or device for a new indication (i.e. a disease for which the drug is not specifically approved). Assess whether the new medication or device is more effective for the patient’s condition than the already used, standard medication or device (“the gold standard” or “standard therapy ”) . Compare the effectiveness in patients with a specific disease of two or more already approved or common interventions for that disease (e.g., Device A vs. Device B, Therapy A vs. Therapy B ). PowerPoint Presentation: 7/14/2014 14 Dipanshu Sur Regulatory Control: Clinical Trial Approval Clinical trials in India are regulated by Revised Schedule Y (2005) of the Drugs and Cosmetics Act and Rules including confirmatory with ICH-GCP guidelines . The Rules are enforced by the office of the DCGI also responsible for monitoring all clinical trials. For new drugs being developed in India clinical trials have to be conducted in India from phase I. For marketing approval of drugs already approved in other countries, a phase III clinical trial is required. Phase I trials of foreign drugs are not permitted, except for drugs of special relevance to India and phase 0 trials are not permitted. Central Drug Standard Control Organization (CDSCO) on 4th Aug 2010 recommends new guide line for clinical trials in India. According to new guideline application in Form 44 is required for grant of permission to import or manufacture a new drug to undertake clinical trial. The prescribed fee for the proposed trials should be submitted through challan TR 5 and TR 6 . The fee for phase I is Rs . 50,000/ and for pivot study (safe study) i.e. phase II and III is Rs . 25,000/- PowerPoint Presentation: 7/14/2014 15 Dipanshu Sur Problem Encountered During Trial: Unseen Concern and Challenges Failure to obtain informed consent . Falsified data. Ethics unawareness. Inadequate source documentation . Protocol noncompliance. Delinquent or inaccurate data submission . In the field of rare diseases sometimes the number of patients might be the limiting factor for a clinical trial. For clinical trials involving a seasonal indication (such as airborne allergies, seasonal affective disorder, influenza), the study can only be done during a limited part of the year (such as spring season for pollen allergies), when the drug can be tested. This can be an additional complication on the length of the study. Physicians are not as familiar with the clinical trial process as they are in the West. Work with local industry, there is a danger of supplies being contaminated because standards are not adopted. The DCGI and Food and Drug Administration (FDA) are understaffed and lack the expertise professionals t o evaluate clinical trial protocols. The sponsors do not guarantee that new drugs tested in India will be made available here at affordable prices. DCGI gives approval to carry out trials, but there are few examples also of doing trials without regulatory approvals . PowerPoint Presentation: 7/14/2014 16 Dipanshu Sur Measures to Counteract the Problems DCGI needs to generate effective monitoring mechanism for continuous evaluation of trials throughout the study period ensuring regular and periodic scientific and ethical review Studies should follow strict adherence to ethical guidelines . All persons involved in study should undergo basic training concerning counseling and preventive strategies. All persons should be recruited in any study after ensuring receipt of proper informed consent for participation. Adequate care and protection should be provided to vulnerable groups . Community involvement at all stages of the studies. Sharing results with all persons involved in research. Ensure global justice, narrowing gap between developed and developing worlds . Prior agreements to ensure that proven interventions will be made to cases of trial discrepancies to prevent exploitation of study participants. Research ethics should be integral part of every biomedical research. All the legislations should be implemented strictly. To favor the promotion of clinical trial in India, restrictions are necessary to ensure that the health of the trial subjects is adequately protected in case of any contingency. It must be assured that the trial subjects are volunteers in true sense not enrolled due to monetary or other incentives, explicitly informed that they are part of a clinical trial. PowerPoint Presentation: 7/14/2014 17 Dipanshu Sur Clinical Trial Registry (CTRI) - India CTRI was launched 20th July 2007. With the launch of clinical trial registry, India became Asia’s first country to have online registry of clinical trials. This is a welcome step seeing the growing business of clinical trials in India and a major step towards accountability, transparency and information sharing on clinical trials. The CTRI is a free and searchable online register of all clinical trials being undertaken in India . The “Responsible Registrant” for a trial is either the principal investigator (PI) or the primary sponsor . PowerPoint Presentation: 7/14/2014 18 Dipanshu Sur Reality of Clinical Trial in India PowerPoint Presentation: 7/14/2014 19 Dipanshu Sur PowerPoint Presentation: 7/14/2014 20 Dipanshu Sur PowerPoint Presentation: 7/14/2014 21 Dipanshu Sur The Way Ahead Selecting the right CRO , tools and techniques. Good contract negotiation between sponsor, hospitals and principal investigators and equal sharing of responsibilities . Strict adoption of Good Clinical Practices (GCP) guidelines rectifying the hurdles. System of prioritizing clinical trials of medications or techniques based on national interests , approving drug trials providing benefits to a substantial segment of the Indian population and for diseases relevant to Indian population. Leverage of private and public resources. Capacity building activities Smart Regulatory system : strengthening ethical review mechanism and accreditation of IECs Allowing phase I and phase 0 trials for drugs developed outside India. Compulsory registration of all CROs with DCGI. Discontinuation or termination of trials with reimbursement to participants should be implemented for fraud and misconduct. “Proper planning and the use of trial sites allows for year-round trials can reduce the length of the studies” PowerPoint Presentation: 7/14/2014 22 Dipanshu Sur Conclusion The outcome of clinical trials has major impact on the manufacturer’s interests and efforts and also on prognosis of disease . Thus clinical trials are not only important to a drug company and patients but also to government, regulators, media, different advocacy groups, ethical police, media, and the general public. Drug companies, pharmaceuticals and medical-device manufacturers have gradually realized the benefits of outsourcing clinical research. Cost-savings are a significant draw card for many pharmaceutical companies when deciding to outsource clinical research to countries in emerging markets such as India. Forming Bioethics Centers in different states or at least in all metropolitan cites can improve the vigilance system on the ongoing trials. Adequate formal training of all the investigators, supervisors and data management staff will help in integrating ethical concerns in a better way and there is also need of introducing courses in government institutions tailoring the shortfalls. Networking between national and international trial centers help in reduction of mishaps in a way by prompt exchange of reports and data. It is the high time that health ministry should adopt hard steps to strong the regulatory mechanism to promote India a clinical trial heaven . PowerPoint Presentation: 7/14/2014 23 Dipanshu Sur Some people see things as they are and say, ‘Why.’ I dream things that never were and say ‘Why not’. ‘‘Once in a while the simple things work right off” PowerPoint Presentation: 7/14/2014 24 Dipanshu Sur Thank You

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