Clinical Trials in India

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