Clinical Trials in India


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Clinical Trials in India

  1. 1. Introduction to clinical research
  2. 2. India has become an attractive destination for outsourced pharmaceutical services. <ul><li>Drive for increased productivity & efficiency in the pharmaceutical industry </li></ul><ul><li>Growth of the biotech sector and the virtual pharma model </li></ul><ul><li>Proven success of other outsourcing plays </li></ul><ul><li>Established track record in Business Process & IT outsourcing </li></ul><ul><li>World leader in the generic and API sectors </li></ul><ul><li>Intellectual Property protection enforcement has evolved </li></ul><ul><li>Well trained, English speaking and computer savvy biomedical workforce </li></ul><ul><li>Cost effective workforce willing and able to adhere meticulously to protocols and processes </li></ul><ul><li>Large heterogeneous “urban centric” patient populations </li></ul>Global Trends Indian Industry Core Competencies
  3. 3. The clinical development sector in India is enjoying rapid growth. <ul><li>Revenues from contract R&D for international sponsors was USD 100 M in 2005 </li></ul><ul><li>Sector enjoying a 40% annual growth rate </li></ul><ul><li>Nascent but dynamic CRO sector </li></ul><ul><ul><li>Quintiles India has been in operation for the past 5 years, with multiplication of resources </li></ul></ul><ul><ul><li>Most global CROs have a presence in or alliance to access India </li></ul></ul><ul><ul><li>Local CROs are gaining momentum but consolidation is inevitable </li></ul></ul><ul><li>Pharmaceutical sponsors are ramping up their clinical operations in India </li></ul><ul><ul><li>Pfizer, Aventis and Eli Lilly are ahead of the rest </li></ul></ul><ul><ul><li>Altana, Merck & Co and GSK are catching up </li></ul></ul>- India’s Clinical Development Sector -
  4. 4. What is clinical research? <ul><li>Organized research on human beings </li></ul><ul><li>intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy. </li></ul><ul><li>Also referred to as Clinical trial management </li></ul>
  5. 5. Clinical research - position in drug development <ul><li>Drug development </li></ul><ul><li>Discovery research </li></ul><ul><li>Formulation and development </li></ul><ul><li>Clinical development(trials) </li></ul><ul><li>Commercialization </li></ul>
  6. 6. India offers pharmaceutical services at various stages of the value chain. Target Identification & Validation Lead Generation & Optimisation Pre-Clinical Development Ph I Ph II & III Contract Manufacturing <ul><li>Less developed academic expertise </li></ul><ul><li>Investment incongruity </li></ul>Pharmaceutical Value Chain with Offshoring Opportunities <ul><li>Medicinal Chemistry </li></ul><ul><li>Custom chemical synthesis </li></ul><ul><li>Molecular Modelling </li></ul><ul><li>Virtual Screening </li></ul><ul><li>Pharmaco-kinetics </li></ul><ul><li>Animal Testing </li></ul><ul><li>Toxicology </li></ul><ul><li>Bioequival-ence </li></ul><ul><li>Limited first in man studies </li></ul><ul><li>Clinical Trials </li></ul><ul><li>Data Management </li></ul><ul><li>Central Lab </li></ul><ul><li>Biostats </li></ul><ul><li>APIs </li></ul><ul><li>Formulations </li></ul><ul><li>Finished product </li></ul><ul><li>Clinical trial supplies </li></ul>
  7. 7. Why do we need clinical trials? <ul><li>new drugs </li></ul><ul><li>for new uses of existing drugs, </li></ul><ul><li>medical devices, </li></ul><ul><li>new drug delivery systems etc. </li></ul>
  8. 8. Why do we need clinical trials? <ul><li>Evidence to prove the efficacy and safety in human beings. </li></ul><ul><li>Only a well designed clinical study on a defined population can give meaningful results- (positive or negative) about any therapeutic intervention </li></ul>
  9. 9. Scope of clinical research? <ul><li>Total cost of the drug development </li></ul><ul><li>750-900 million US $ </li></ul><ul><li>Total time taken for the drug development </li></ul><ul><li>9-10 years </li></ul><ul><li>2/3rds of the drug development cost and time is spent on clinical trials development </li></ul>
  10. 10. Regulatory guidelines today <ul><li>Drugs and cosmetics act 1947 </li></ul><ul><li>SCHEDULE-Y </li></ul><ul><li>Indian GCP GUIDELINES </li></ul><ul><li>ICMR Guidelines </li></ul><ul><li>WHO Guidelines </li></ul><ul><li>ICH-GCP Guidelines </li></ul>
  11. 11. Clinical research -a multi-disciplinary approach <ul><li>Sponsor </li></ul><ul><li>Investigators </li></ul><ul><li>Monitors </li></ul><ul><li>Auditors and the quality control personnel. </li></ul><ul><li>Biostatisticians. </li></ul><ul><li>Data management group. </li></ul><ul><li>Regulatory Affairs. </li></ul><ul><li>Reporting and Documentation medical writing. </li></ul><ul><li>Business development group </li></ul>
  12. 12. Players in Clinical Research Industry <ul><li>Pharma companies </li></ul><ul><li>Clinical/contract research organisations(CROs) </li></ul><ul><li>Biotech companies </li></ul><ul><li>Central diagnostic laboratories </li></ul><ul><li>Clinical research training institutes </li></ul>
  13. 13. NEW DRUG DEVELOPMENT PROCESS <ul><li>Drug discovery </li></ul><ul><li>Synthesis </li></ul><ul><li>Drug designing </li></ul><ul><li>Target validation(Preliminary in-vitro screening) </li></ul><ul><li>Pharmacological assays </li></ul>
  14. 14. PRECLINICAL STUDIES <ul><li>Include studies conducted on Experimental animals for safety and efficacy </li></ul><ul><li>. </li></ul>
  15. 15. Toxicity studies <ul><li>Acute toxicity studies LD50 </li></ul><ul><li>Sub- acute toxicity studies </li></ul><ul><li>Chronic toxicity studies </li></ul><ul><li>Special toxicity studies-carcinogenecity,teratogenecity </li></ul><ul><li>genotoxicity, </li></ul><ul><li>effects on fertility and reproduction </li></ul>
  16. 16. PRECLINICAL STUDIES <ul><li>Efficacy studies </li></ul><ul><li>In- vitro assays </li></ul><ul><li>Studies conducted using only animal tissues or cells or enzyme systems </li></ul><ul><li>In- vivo assays </li></ul><ul><li>Experiments using whole animals </li></ul>
  17. 17. CLINICAL TRIAL PHASES <ul><li>Phase-I- Clinical pharmacology,safety of new drugs </li></ul><ul><li>Phase-II -safety and efficacy of new drug in patients,exploratory trial. </li></ul><ul><li>Phase-III -multicentric confirmatory trial. </li></ul><ul><li>Phase-IV -post- marketing surveillance </li></ul>
  18. 18. Who conducts the clinical trial? <ul><li>Investigators </li></ul><ul><li>Principal investigator </li></ul><ul><li>Co-investigator </li></ul>
  19. 19. Who participates in the trial? <ul><li>Subjects </li></ul><ul><li>Patients </li></ul><ul><li>Healthy human volunteer </li></ul>
  20. 20. Regulatory requirements <ul><li>Drugs and cosmetics act </li></ul><ul><li>Schedule-Y </li></ul><ul><li>DCGI Drug controller General of India </li></ul><ul><li>US-FDA United states-Food and drug administration act. </li></ul><ul><li>MHRA Medicinal and health care products regulatory agency </li></ul>
  21. 21. MONITORING <ul><li>Overseeing the progress of a clinical trial </li></ul><ul><li>Ensuring that it is conducted according to the protocol,GCP,SOPs and the regulatory requirements. </li></ul><ul><li>Usually conducted by Clinical research associates. </li></ul>
  22. 22. SUMMARY <ul><li>Clinical research is an integral part of drug development </li></ul><ul><li>Unlike the past, today the process has gained a unique position due to the regulatory requirements and ethical guidelines available globally. </li></ul><ul><li>Designing, conducting,monitoring, appropriate quality assurance and data management determine the success of the clinical research. </li></ul>
  23. 23. Major Players
  24. 24. Career Path
  25. 25. Career Pipeline