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Accelerating Clinical Research For Inclusive Development

  1. 1. ACCELERATING CLINICAL RESEARCH FOR INCLUSIVE DEVELOPMENT Gopal Pai, PhD Head, Clinical Operations Clinigene International Limited (A Biocon Company) 03 Aug 2011
  2. 2. <ul><li>DISCLAIMER </li></ul><ul><li>The views and the material collated is the author’s personal view </li></ul><ul><li>These views are for those who are law abiders and enable the law to better </li></ul><ul><li>Pictures and materials in this presentation are picked from open source e-pages, my thanks to the original owners </li></ul><ul><li>Views presented here are in favour of clinical research which is the back bone of today’s evidence-based medicine </li></ul><ul><li>Practices and suggestions of the future presented here are not guaranteed and left to the public to decide </li></ul><ul><li>Special Thanks to identified sources : </li></ul><ul><li>CDSCO website </li></ul><ul><li>CTRI website </li></ul><ul><li>ICMR website </li></ul><ul><li>ICH website </li></ul><ul><li>About.com website </li></ul><ul><li>CCSVI.mx website </li></ul><ul><li>Amar Jesani, Indian Journal of Medical Ethics, Centre for Studies in Ethics and Rights, Mumbai (ppt) </li></ul><ul><li>Consensus Group, Journal of Child & Adol. Psychopharmacology,,13(1),2003,pp13-27 </li></ul>
  3. 3. ONCE A VERY NOBLE PROFESSION……
  4. 4. CRUCIAL FOR DEVELOPMENT OF NEW MODALITIES <ul><li>Clinical Care dilemmas / controversies </li></ul><ul><li>Gene therapies, Stem cell therapies </li></ul><ul><li>GM products for human consumption </li></ul><ul><li>Cloning </li></ul><ul><li>Blood donations, transfusions </li></ul><ul><li>Organ transplants </li></ul><ul><li>Contraception </li></ul><ul><li>HIV testing , counseling </li></ul><ul><li>Clinical laboratory testing </li></ul><ul><li>In vitro fertilization / sperm banking </li></ul><ul><li>Abortions / euthanasia / sex determination </li></ul><ul><li>Consents provided by patients and their relatives at all hospitals </li></ul><ul><li>Insurance coverage in medical care </li></ul><ul><li>Narcotic drug use/abuse </li></ul><ul><li>Taste enhancers </li></ul><ul><li>Artificial sweeteners </li></ul><ul><li>Pollution control </li></ul><ul><li>Exposure to sunlight </li></ul><ul><li>Daily dietary components (pediatric, adult) </li></ul><ul><li>Smoking… </li></ul>Is Clinical Research any different ?!
  5. 5. … NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
  6. 6. Development of medical practice Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
  7. 7. as much “ art ” as it is “ science ” much of evidence-based medicine is a “ gold-standard in treatment approaches”, keeping the &quot;art&quot; aspect in mind … is as good an approach as any to determining whether evidence-based medical study results are useful to you as you and your doctor consider possible treatment for whatever your medical problem is. From ART to Evidence Based Medicine “ Art” factor
  8. 8. INDIA – HEALTH CARE & CLINICAL RESEARCH <ul><li>Relatively well-developed health care services: </li></ul><ul><ul><li>Over half a million doctors in Modern System of medicine; </li></ul></ul><ul><ul><li>Another half a million doctors of Indian systems and homeopathy </li></ul></ul><ul><ul><li>Out-migration of doctors </li></ul></ul><ul><ul><li>Over 15,000 hospitals (estimates) </li></ul></ul><ul><ul><li>250 Medical Schools (Modern System) </li></ul></ul><ul><ul><li>Burgeoning pharma industry - third of pharma production exported </li></ul></ul><ul><ul><li>Medical tourism & corporate hospital business encouraged </li></ul></ul><ul><li>No universal access to health care: </li></ul><ul><ul><li>80% of health services in private sector </li></ul></ul><ul><ul><li>Less than 10% covered under voluntary health insurance </li></ul></ul><ul><ul><li>75% of health care financed by out-of-pocket expenditure </li></ul></ul><ul><ul><li>Cost of health care a major cause of poverty </li></ul></ul><ul><ul><li><0.0001% covered under clinical trials currently (rough estimates) </li></ul></ul>
  9. 9. So what raises questions on EBM in India ?
  10. 11. Should the EBM stop ?
  11. 12. CR in India : Enablers ! <ul><li>10 Steps that ensure inclusive & voluntary participation in Indian research projects: </li></ul><ul><li>* Regulatory status of the drug / device / treatment (Approval by CDSCO) </li></ul><ul><li>* Data of past exposure with human and/or animal (Sch Y, Y1 - CDSCO) </li></ul><ul><li>* Insurance cover for study-drug related injury to subjects (CDSCO) </li></ul><ul><li>* Investigational sites with Regulatory & GCP training (ICH & Indian GCP) </li></ul><ul><li>* Inspections of CROs, Sponsors and Sites by CDSCO </li></ul><ul><li>* CRO registration with CDSCO </li></ul><ul><li>* Informed Consent Process and documentation of the process </li></ul><ul><li>* Use Pharmacovigilance network development </li></ul><ul><li>* CTRI registration (Public information enabled by CDSCO) </li></ul><ul><li>* Ethics /Scientific committee approvals (ICMR guide, OHRP Registered?) </li></ul>
  12. 13. Current Indian PV model - 1
  13. 14. Current Indian PV model – 2
  14. 15. … More patient PROTECTIVE MEASURES available <ul><li>Protective mechanisms in place to allow continuation of studies: </li></ul><ul><ul><li>DMC (Data monitoring committee) </li></ul></ul><ul><ul><li>DMEC (Date monitoring and ethical committee) </li></ul></ul><ul><ul><li>DSMBs (Date Safety Monitoring Board) </li></ul></ul><ul><ul><li>Regular and periodic IRB safety reviews </li></ul></ul><ul><li>So what is missing in Clinical Research today ? </li></ul><ul><ul><li>Regular surveillance mechanisms from CDSCO and other audit firms </li></ul></ul><ul><ul><li>Training in medical schools on ethics in EBM </li></ul></ul><ul><ul><li>Community involvement and awareness of clinical research </li></ul></ul><ul><ul><li>Patient protection groups (with balanced views) </li></ul></ul><ul><ul><li>Research societies / specialty bodies (with balanced views) </li></ul></ul><ul><ul><li>Accreditations for ECs, CROs and CR personnel (various skill sets) </li></ul></ul><ul><ul><li>Control and register SMOs (many sub-standard ones mushrooming!) </li></ul></ul><ul><li>Hospitals: Largely no-health care regulations </li></ul><ul><ul><li>laws for registration in some states </li></ul></ul><ul><ul><li>no standards set </li></ul></ul><ul><ul><li>no universal accreditation mechanism </li></ul></ul><ul><ul><li>proposed national law (awaited) </li></ul></ul>
  15. 16. INDIA: IEC Challenges <ul><li>IECs: Main regulatory bodies </li></ul><ul><ul><li>Registrations, meeting ICMR guidelines (awaited) – more political will needed for comprehensive legislation </li></ul></ul><ul><ul><li>Decentralized, and under control of institutions </li></ul></ul><ul><ul><li>No independent authority for IEC oversight, financing </li></ul></ul><ul><ul><li>ICMR started the NIH supported research bioethics training </li></ul></ul><ul><ul><li>No data on functioning of IECs, no reports </li></ul></ul><ul><ul><li>Controversies about specific trials, but no IEC made accountable </li></ul></ul><ul><ul><li>Need good processes for local & national priority setting, what kind of research to undertake </li></ul></ul><ul><ul><li>Simplified rules for medical care and compensation for research injuries </li></ul></ul><ul><ul><li>Utility of outcome of research for community and country – big ideals, but no practical/legal guidance </li></ul></ul><ul><ul><li>Processes often derailed due to dependence on institutions, Conflict of Interests, Corruption and lack of competence </li></ul></ul><ul><ul><li>Quality of functioning of ethics committees needed </li></ul></ul><ul><ul><li>What are the ethical obligations of IEC members to society </li></ul></ul><ul><ul><li>Transparency and accountability – two tools </li></ul></ul><ul><ul><li>not used sufficiently in health care & clinical research </li></ul></ul>
  16. 17. THANK YOU ! <ul><li>Like in other walks of life, </li></ul><ul><li>nothing works more than the restraint on the continued temptation </li></ul><ul><li>to get on to the wrong side of the law to make a quick buck! </li></ul><ul><li>(Ethics rule our lives, others ruin them !) </li></ul><ul><li>… so far as the law is around, </li></ul><ul><li>the police will be around, </li></ul><ul><li>… so far as the police are around, </li></ul><ul><li>the criminals will also be around ! </li></ul><ul><li>Is this ANY different in other spheres of life ? </li></ul><ul><li>… so is only Clinical research profession in a dilemma?! </li></ul>

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