Clinical research


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Clinical research

  1. 1. Clinical Research in India Drivers for changing perceptions Dr Dilip Pawar MD, PhD, MCSEPI, DPBM, DCA, MASCPT(USA), MASPET(USA), FCP(USA), MBA Fellow Of American Society Of Clinical Pharmacology Director & Chief Scientific Advisor Institute of Clinical Research Education and Research Chief Executive Officer & Global Medical Director Drug Research Laboratory; MUMBAI, INDIA Dr Dilip Pawar 1
  2. 2. WELCOMEDr Dilip Pawar 2
  3. 3. Dr Dilip Pawar 3
  4. 4. INDIA POPULATION URBAN 345 million LIFE EXPECTANCY Total 1 billion 68 YEARS INDIAEXPENDITUR ON HEALTH E URBAN LITERACY 6%OF GDP MALES 82% (1.2% Government Spend) FEMALES 64%•Fourth largest economy in theworld•Second fastest growing economy in BIRTH RATE 27 per 1000the world DEATH RATE 8 per 1000•Projected GDP growth rate – 8% INFANT MORTALITY 77 per 1000•Healthcare, Pharma, Biotech, IT,BPO, telecom are fastest growing Dr Dilip Pawar 4sectors
  5. 5. Life Span 119 120 Population >65 years (million) 100 80 72 62 58 60Life Expectancy 42 32 40 20 0 1947 1980 1998 2020 2025 1991 Dr Dilip Pawar 5
  6. 6. Population – Pronounced Rural to Urban Migration 2000 (1000mn) 2025 (1400 mn) 218 mn 1990 (846 mn) 340 mn Prevalence of Illness 10% 22%• Rapid recruitment 15-60 years > 60 years(20-30% time advantage ifstudies are conducted in India URBAN POPULATION– Ernst & Young) PREVALENCE OF ILLNESS Dr Dilip Pawar 6
  8. 8. Diseases and Patients Changing Disease Patient Population  8 million Epileptics Patterns  40 million Asthmatics Cardiovascular diseases  ~34 million Diabetics Degenerative neurological diseases  8-10 million HIV +ve Diabetes  3 million Cancer patients Cancer  > 2 million Cardiac deaths Psychiatric illnesses  1.5 million Alzheimer Gastro Intestinal Disorders patients Infectious Diseases  1 million PD patients Tropical diseases  15% Hypertensive 1% Schizophrenia patients  India has diseases of the tropical world plus diseases of the developed countries Dr Dilip Pawar 8
  9. 9. India – Ethnic DiversitySuccessive waves of visitors / invaders from the North – Dravidians driven southwards  Aryans from Central Asian steppes – 1500 BC (pale skinned and light-eyed)  Greeks (Yavanas) Today  Scythians Caucasians 80%  Parthians Dravidians 20%  Iranians (Persians)  Also Turks, Huns, Chinese, Ethopians • Ethnic diversity - majority CaucasianLater Portuguese, Dutch, French, Moghuls (Mongols), English Dr Dilip Pawar 9
  10. 10. The ‘Language’ Advantage Languages - 15 official languages Hindi - National language - Mother tongue of 30% of people English - Language for communication • Hospital Management Teaching - Medical, Nursing & Pharmacy • Source documents ENGLISH Communication with Regulatory Authorities Labeling of Medicines Dr Dilip Pawar 10
  11. 11. Medical Practice in India Multiple systems  Ayurveda  Other traditional Indian systems  Homeopathy  Western system; most widely practiced Multiple systems of therapies Dr Dilip Pawar 11
  12. 12. Pharmaceutical industry- Past Clinical trials not mandatory till 1987 Market of branded generics No incentive for research Innovator companies indifferent Local industry not serious about clinical trials No data exclusivity & patent protection Dr Dilip Pawar 12
  13. 13. Medical profession Did not question source of references Did not demand local evidence Patient care Ist priority Not familiar with GCP needs Did government funded research Lack of appreciation of mutual needs Dr Dilip Pawar 13
  14. 14. IRBs Very few in number Mainly reviewed animal studies & post graduate theses Not US FDA compliant No SOPs Not much attention paid to ICF Patient reimbursement not permitted Dr Dilip Pawar 14
  15. 15. Why Not India until recently? High importation duty (55%) No provision in drug laws for global studies No incentive for PI’s; academic institutions suspicious of clinicians No Data Exclusivity Long start up times Dr Dilip Pawar 15
  16. 16. Changing perceptions and a new environment Drivers:  WTO  Need to globalize  Encourage Private public partnership  Intense lobbying by MNCs  Shift of focus of the indigenous industry; from process to product  Economic sense Dr Dilip Pawar 16
  17. 17. OUTSOURCING OPPORTUNITIES - INDIA Bulk Drugs Contract Contract & Marketing & R&D Formulations Sales ManufacturingMedicinal InternationalChemistry Clinical Trials Plant OutsourcingMachinery Opportunities - Technical & India Services PharmaEquipment Primary Herbals Packaging Neutraceuticals Bioinformatics Materials Biostatistics Software Development Dr Dilip Pawar 17
  18. 18. Why India Now? No importation duty Patent act amended; IPR in place Data Exclusivity – Export procedures simplified Drug laws amended to permit global studies Dr Dilip Pawar 18
  19. 19. Why India….. GCP compliant IRB’s Untapped patient population English business language GCP guidelines ICH compliant Start up time reduced to 8-12 weeks CAP certified central labs Dr Dilip Pawar 19
  20. 20. Clinical Trial Environment Change Drivers Government and Regulatory Environment more conducive to clinical research • GCP guidelines introduced by ICMR and DGHS • Customs levies on clinical trial drug supplies eliminated Patent rules harmonised Healthcare and Healthcare delivery improvements • Tertiary Hospital Infrastructure • GCP awareness • Healthcare Industry - Rs.100,000 croresEpidemiological Transition of • Growing demand by Middle Class Disease - Patterns changing • Good connectivity • Increasing use of IT and InternetHealth Insurance expansion • Transfer of ECGs and Imaging - now routine - private participation emphasis on preventive care Good Courier Systems within India and to other countries Dr Dilip Pawar 20
  21. 21. Skilled workforce High quality research with domain expertiseMaintenance oftime schedules INDIA Shortening time to market Therapeutic Expertise Technology support Dr Dilip Pawar 21
  22. 22. Regulatory milestones Mandatory clinical trials for the first applicant – 1987 BE for subsequent applicants – 1987 GCP committee formed – 1995 Ethical guidelines - 2000 GCP guidelines released – 2001 Drug laws amended to permit simultaneous phase global trials - 2005 Dr Dilip Pawar 22
  23. 23. Recipe for success in India MOH approval easy if US IND/ EMEA application Understand PI behavior – financial negotiations Invest in training PIs, IRBs Promote young, enthusiastic PIs Dr Dilip Pawar 23
  24. 24. Nascent but Fast Growing - India’s Clinical Development Sector - Annual Revenues USD 120 M with 40% growth in past year 240 international studies recruiting subjects = 1.2% of the total studies worldwide 66% of international clinical trials are Phase III 207 sites FDA registered 40,000 subjects participated in clinical trials to date (<0.02% of population) Dr Dilip Pawar 24
  25. 25. Recent India Regulatory Reform makes Approvals Possible within 6 weeks. Regulatory body Approval TimeDrugs Controller Regulatory approval for  4 weeks – FAST TRACK,General of India (DCGI) study conduct in India US,UK,CANADA,SWITZERLA ND,GERMANY,EMEA, AUSTRALIA, JAPAN CTA available  16 weeks, no documentation to support successful US/EU CTADrugs Controller Test license to import 2 weeks in additionGeneral of India (DCGI) trial suppliesEthics Committees Local Ethics committee 6 – 8 weeks (in parallel) approval by sitesTotal (parallel processing) - 6-8 weeks – FAST TRACK 16 weeks (track B)Directorate General of Permission to export Additional 2 to 4 weeksForeign Trade (DGFT) blood samples Dr Dilip Pawar 25
  26. 26. Meticulously Following Prescribed Process Is Key. Regulatory & IRB Approval Process:India PI submits CDA signed, Consent Letter application Queries Approvals Site Selected, from PIs to EC from EC from EC Release Protocol reply to queriesContract/LOI Approvalsexecuted from ECAll documents Sponsor / CRO to PIreceived Regulatory Regulatory Regulatory DGFT Internal review dossier submission Approval Export License of dossier compilation to DCGI from DCGI Application Export License Submission Obtained to DGFT from DGFT Dr Dilip Pawar 26
  27. 27. Don‘t set too ambitious deadlines Deadline is deadline ! Dr Dilip Pawar 27
  28. 28. India — Gradually Building a Track Record Dr Dilip Pawar 28
  29. 29. Clinical Trials Outsourced to India Differing DynamicsI. Clinical Trials on diseases of topics e.g. Locations – usually outside urban areas malaria, TB, leishmaniasis Benefits to India – likely / immediateII. Clinical Trials on diseases/ disorders of a Sponsors – Industry and Others primitive economy e.g. Locations – urban and perirural  Acute infections Benefits to India – likely / immediate  Nutrition-related  Reproductive health-related  AIDSIII. Clinical Trials on diseases/ disorders of a Sponsors – Industry developed economy e.g. Locations – urban  Cardiovascular Test molecules – drugs in development  CNS including neurological degeneration and Data for regulatory submission psychiatry Benefits to India – likely / immediate  Gastrointestinal  Diabetes  Cancers Dr Dilip Pawar 29  AIDS
  30. 30. India offers Cost Saving Potential Overall Indexed Clinical Trial Costs India 0.56 China 0.52 Russia 0.4 Australia 0.73 US 1 Spain 0.93 Germany 1.2 France 0.71 UK 1.09 Poland 0.77 0 0.2 0.4 0.6 0.8 1 1.2 1.4Source: FastTrack Systems Global Cost Databases Dr Dilip Pawar 30
  31. 31. Mckinsey ReportIndian CR market will grow to US $1.5 billion in value by 2010. Dr Dilip Pawar 31
  32. 32. Choose Good Investigators Need local understanding and global experience India has experienced Investigators Concern factors :  Using Investigator groups (some will be great, others might not)  When inexperienced, assess willingness and motivation to learn and then train and retrain Dr Dilip Pawar 32
  33. 33. INDIA - Perceptions & Realities Perception Reality Many sites in India are trained in GCP – nowGCP awareness absent or low mandated by Government Various audits of the study show no adverse findingData integrity in question In India US FDA has audited sites with no major commentsDifferent languages cause English used for all healthcare-relatedconfusion and escalate costs activities, systems, procedures and drugbecause of need to translate labels. Only patient-related documents needdocuments translation Telecommunication facilities good in urbanTelecommunication poor areas. Connectivity good – EDC studiesConnectivity poor possible – electronic transmission of ECG, imagings frequent. Dr Dilip Pawar 33
  34. 34. Is Clinical Research is an attractive Option for INDIA Dr Dilip Pawar 34
  35. 35. Key Messages India is well placed to provide solutions for contemporary and future clinical research Can facilitate affordable drug research Has required patient populations and qualified scientists and clinicians Has the information technology competitive advantage Has a regulatory framework which is moving towards regulatory harmonization The socio-economic transformation in urban India understands contemporary GCP requirements Rapid urbanisation and exposure to developed world facilitates cross-cultural understanding Product patents from January 1, 2005 Dr Dilip Pawar 35
  36. 36. The Opportunities ahead In Clinical Research Opportunities are many Not Only in India but also internationally GRAB THE OPPORTUNITY……. Dr Dilip Pawar 36
  37. 37. Dr Dilip Pawar 37
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