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Careers In Clinical Research Industry Gp 06 Nov11
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Careers In Clinical Research Industry Gp 06 Nov11

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  • 16 We take pride in our integrity as a company that improves people’s lives. We are devoted to maintaining top performance through teamwork . We value innovation in our products and leadershi p in our groups. We are committed to serving the communities around us. We are a corporation with a high respect for people and a sharp customer focus . These are our values at Pfizer.
  • Transcript

    • 1. A quick road map Gopal Pai, Ph.D. Head, Clinical Operations, Clinigene International Limited (A Biocon Company), Bangalore
    • 2. Out-sourced / In-sourced / Combination Customer Focus Respect for People Integrity Innovation Teamwork Leadership Performance Community
    • 3.  
    • 4.  
    • 5.  
    • 6.  
    • 7. In Vitro Screening Tests
    • 8. In Vitro Screening Tests Animal Model Screening Tests
    • 9. In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Animal Toxicity Studies
    • 10. In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Toxicity Studies Sub-Acute & Acute Chronic Animal Safety Studies
    • 11. Sub-Acute, Acute & Chronic Animal Safety Studies
      • Reproductive
      • Fertility
      • Fetal
      • Perinatal
      • Post-natal
      • Carcinogenicity
      • Teratogenicity
      • Mutagenicity
      • Topical toxicity
    • 12. Acute Sub-Acute & Chronic Animal Safety Studies Pharmaceutical Development
      • Preformulation
      • Formulation
      • Process development
      • Stability & shelf-life
      • Scale-up
    • 13. Acute & Sub-Acute Chronic Animal Safety Studies Pharmaceutical Development Clinical Development
    • 14.
      • Biography of a drug from its inception in the lab to its introduction to the consumer market and beyond.
      • Tests the drug for its efficacy and toxicity in humans
      • It continues throughout the lifetime of the drug to include post marketing surveillance where a periodic 'progress report' is submitted to the regulatory authorities once every 2 years after the drug is released into the market and also into Pharmacovigilance where safety of marketed drugs, biologics or medical devices are monitored.
    • 15. Clinical Development Phase I Phase II Phase III Phase IV
      • Marketing permission
      • New indications
      • Post-marketing surveillance (PMS)
      • Pharmacoepidemiology
      • Pharmacoeconomics
      • Pharmacovigilance
      • Risk complexity
      • Scientific rigor
    • 16.
      • First trials of drugs in humans (healthy volunteers)
      • Preliminary evaluation of safety & toxicity
      • Establishes pharmacokinetic and pharmacodynamic profile
      • Various dosage forms/strengths may be tested
      • Limited number of volunteers are usually used (12-32)
    • 17.
      • Establishes efficacy for proposed diseases or conditions
      • Assesses short term safety
      • Determines appropriate route of administration, dose range & frequency
      • Small number of subjects (generally exceeding 24-30 subjects)
    • 18.
      • Large scale trials to obtain efficacy & safety data
      • Evaluates the therapeutic values of drug
      • May also involve differentiation from other existing therapies
      • Establish pharmaco-economic importance
      • Generally comparative studies are common
      • Number of subjects could exceed 300
    • 19.
      • Conducted after the drug route, dose & frequency are established
      • Studies performed according to approved labeling only
      • Post-marketing surveillance (safety/toxicity)
      • To differentiate from other existing therapies
      • Pharmacoeconomic evaluation
      • Increase usage and awareness in practice
      • Range exceeds 1000 subjects
    • 20. International Scientific & Ethical quality Standard DESIGN REPORT RECORD COLLECT Patient Safety Credibility of Data Execute Verify Analyze Publish / market Services Audits & Inspections
    • 21. Declaration of Helsinki ICH-GCP Local regulations Protocol, SOPs
    • 22.
      • Conduct of study per Declaration of Helsinki, GCP and applicable local regulations
      • Research, only if benefits justify risks
      • Focus on Patients rights & Safety
      • Adequate supporting information
      • Scientifically sound protocol
      • EC approval
      • Medical care of subjects by physician
      • Training
      • Informed Consent
      • Recording & storing of information
      • Confidentiality of subjects
      • Supplies in conformity with GMP, Protocol
      • Quality systems
    • 23.  
    • 24. CR Training Institute
    • 25.
      • choose a specialty
      • like academics
      • possesses some industry experience
      • understand and appreciate the difference in academic and industrial standards of CR
      • skills of teaching and motivating students
    • 26. Synopsis Reg. approval pre-study inv. meet Idea Idea Final Protocol Final CRF Drug Supply Inv. & site selection Final Report Safety Monitoring Data processing & analysis Close-out Inv. Meet & EC approvals Site Initiation Monitoring Audits & inspection
    • 27. Project Manager SPONSOR REGULATORY BODY Senior mgmt approval Study Monitor Investigator Central Laboratory Patients Labs / Services Data management & Biometrics Vendors CRA CRA CRA CRA Ethics Committee
    • 28. Hospital / Institute Investigator Contract Research Organization Sponsor
    • 29.
      • Highly Experienced & skilled researchers
      • clinical scientists, clinicians
      • project planners, market researchers
      • Voracious readers and analyzers
      • Forward thinkers
      • Converting theory into practice
      Product development team Very senior positions (MD, PhD or higher) Synopsis Reg. approval pre-study inv. meet Idea Idea
    • 30.
      • Experienced
      • clinical scientists, clinicians
      • project planners, clinical writers, statisticians
      • Voracious readers and writers
      • Forward thinkers
      • Converting theory into practice
      Dept: Clinical Writing Junior – Senior positions (min. Masters/ PhD) Synopsis Regulatory approval Idea Idea
    • 31.
      • Experienced
      • Regulatory specialists / writers
      • (needs knowledge of international drug and CR laws in various countries)
      • Specialized in understanding and strategizing
      • Liaison with drug and health authorities
      • Liaison with academecians and practitioners
      • Compile submissions for regulatory authorities
      Dept: Regulatory Affairs Junior - Senior positions Min: Sc/Ph G/PG Synopsis Regulatory Strategies & approval Idea Idea
    • 32.
      • Experienced
      • clinical specialists / writers
      • (needs team skills and negotiation skills)
      • Specialized in understanding and strategizing
      • Liaison with other specialities and departments
      • good team player and negotiator
      • good clinical writing skills & experience
      Dept: Clinical Writing Junior - Senior positions Min: Sc/Ph PG Final Protocol Final CRF Drug Supply Inv. & site selection
    • 33.
      • Experienced
      • IT professionals in CRF designing and forms
      • (needs team skills and negotiation skills)
      • specialized in layout and designing forms
      • expert in flow of data collection instruments
      • understanding of database and data validation rules
      • good team player and negotiator
      • good IT skills & experience
      Dept: Data Management Junior - Senior positions Min: G/PG (IT specialists) Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    • 34.
      • Pharma mfg (cGMP), storage & distribution
      • Experience in packaging and labeling
      • Experience in randomization and blinding supplies
      • specialized manufacturing in cGMP for CR supplies
      • knowledge of inventory management
      • storage & distribution logistics management
      • specialization in randomization and blinding techniques
      Dept: Clinical supplies Junior - Senior positions Min: Pharm/B.tech G/PG Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    • 35.
      • Experienced Project managers
      • Regulatory documentation specialists
      • Site start-up specialists / site auditors
      • knowledge of infrastructure and capabilities mapping
      • knowledge of GCP documentation requirements
      • thorough with GCP compliance and medical records
      • detection of deficiencies and negotiation skills
      • requires travel about 50-60%
      Dept: Investigator services Junior - Senior positions Min: G/PG (Bio) Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    • 36. Dept: Administration Junior - Senior positions Min: G/PG (event managers/ travel agents) Dept: Ethics Committee Very senior positions Min: composition per ICMR guidelines (highly qualified and experienced individuals only) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    • 37.
      • Project managers
      • Clinical Research Associates
      • specialized in setting up sites for projects
      • assessing sites for GCP compliance, facilities and capabilities
      • training site staff for implementation of protocol requirements
      • helping site staff to upgrade documentation skills
      • help understanding of protocol logically & scientifically
      • helper, supervisor, negotiator, motivator
      Dept: Clinical Operations Junior - Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    • 38.
      • Clinical Research Associates
      • helper, supervisor, negotiator, motivator
      • takes care of staff changes and ongoing training
      • continued assessment for
        • GCP, ethical and protocol compliance
        • authenticity of data collection
        • facilities and capabilities
        • training site staff (turn-over)
        • travel 75-85%
      Dept: Clinical Operations Junior - Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    • 39.
      • Internal auditor
      • (generalist and experienced)
      • independent observer & reporter
      • assesses the compliance to
        • standard operating procedures (SOP)
        • GCP, ethical and protocol compliance
        • quality of monitoring by study team
        • Verify data generation, facilities, capabilities
        • training site staff (turn-over)
        • travel 60-75%
      Dept: Quality Assurance / Govt drug inspector Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits / Govt. inspection
    • 40.
      • Medical officer / Safety officer
      • (experienced)
      • medical terminology & knowledge
      • assesses the safety of all participating subjects
        • follow regulatory reporting guidelines
        • follow up and manage AE / SAEs
        • make medical decisions on continuation of subjects
        • make medical decisions on continuation of protocol
        • documentation requirements
        • analysis skills in drug development
      Dept: Drug Safety / Pharmacovigilance Junior - Senior positions Min: MD / G/PG (Bio) Final Report Safety Monitoring Data processing & analysis Close-out
    • 41.
      • Database designer / Database programmer
      • Data entry / Data manager / Medical coders
      • (experienced)
      • IT specialists
        • (range : computer operator – programmers)
      • Database (generally clinical Oracle / Oracle
        • system admin, database builder, database programming
        • web-page programmers and linking databases
      • Data entry
        • basic keyboard, medical terminology skills
      Dept: Data management (Database team) Junior - Senior positions Min: IT skills (G) + nursing Final Report Safety Monitoring Data processing & analysis Close-out
    • 42.
      • Data manager / Medical coders
      • IT specialists (range : database programmers )
        • Knowledge of CDISC standards
        • Knowledge of programming
        • validation of the database structure
        • validation of edit check programs
      • Medical knowledge with IT skills
        • knowledge of WHO / Medra dictionary
        • mapping of diverse terms to standard terms
      Dept: Data management (Data Cleaning & Validation) Junior - Senior positions Min: IT skills / G / BDS / MBBS / Nursing Final Report Safety Monitoring Data processing & analysis Close-out
    • 43.
      • SAS programmers / Biometricians
      • IT specialists (range : SAS programmers )
        • Knowledge of CDISC standards
        • Knowledge of programming & validations
        • Generation of tables and listings
      • Biometrics knowledge with IT skills
        • generate a Statistical Analysis plan
        • decide methods and validate programs
        • approve tables and listings generated
      Dept: Biometrics (Data analysis, Tables and listing ) Junior - Senior positions Min: IT skills + Nursing / PG/PhD Biostats Final Report Safety Monitoring Data processing & analysis Close-out
    • 44.
      • Data managers & CRAs
      • Generate queries
          • Clean database for database lock and release for analysis
          • Generation of Final tables and listings (100% accurate)
      • Resolve queries
          • Help resolve queries and verify data at site
          • Collection of essential documents
          • Close site
      Final Report Safety Monitoring Data processing & analysis Close-out
    • 45.
      • Clinical Writers / Medical Advisors / Project Managers / Biometricians
      • use Final tables & listings for reports/publications
      • have a good knowledge of regulatory submission requirements internationally
      • analytical skills to interpret data and make conclusions
      • data organization, language and writing skills
      Final Report Safety Monitoring Data processing & analysis Close-out
    • 46.
      • Clinical writers
        • SOP writing and administration (re/training, implementation and archival)
      • Project Management
        • Tracking large projects with MS-Projects (Gantt charts, critical path and mile stones)
        • Productivity and resourcing (use of timesheets, costs, tasks and activities, P&L for each project)
        • Financial tracking (Project finance)
      • Legal & Contracts mgmt (vendors and sites)
    • 47.
      • CRF / label printing & QA
      • Central Laboratory business
      • Business development
      • IVRS
      • Translations
      • Rater training and certifications
      • GCP training and certification
      • Consultant ……
    • 48. Pull Push
      • Team members
      • Competencies
      • Systems Processes
      Push
    • 49.  
    • 50.  
    • 51. CHALLENGES IN DRUG DEVELOPMENT GLOBALLY
    • 52.  
    • 53.  
    • 54.  
    • 55. Once a very noble profession……
    • 56.
      • Gene therapies, Stem cell therapies
      • GM products for human consumption
      • Cloning
      • Blood donations, transfusions
      • Organ transplants
      • Contraception
      • HIV testing , counseling
      • Clinical laboratory testing
      • In vitro fertilization / sperm banking
      • Abortions / euthanasia / sex determination
      • Consents provided by patients and their relatives at all hospitals
      • Insurance coverage in medical care
      • Narcotic drug use/abuse
      • Taste enhancers
      • Artificial sweeteners
      • Pollution control
      • Exposure to sunlight
      • Daily dietary components (pediatric, adult)
      • Smoking…
      Is Clinical Research any different ?!
    • 57. … NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
    • 58. Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
    • 59. as much “ art ” as it is “ science ” much of evidence-based medicine is a “ gold-standard in treatment approaches”, keeping the "art" 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. “ Art” factor
    • 60.  
    • 61.
      • * Regulatory status of the drug / device / treatment (Approval by CDSCO)
      • * Data of past exposure with human and/or animal (Sch Y, Y1 - CDSCO)
      • * Insurance cover for study-drug related injury to subjects (CDSCO)
      • * Investigational sites with Regulatory & GCP training (ICH & Indian GCP)
      • * Inspections of CROs, Sponsors and Sites by CDSCO
      • * CRO registration with CDSCO
      • * Informed Consent Process and documentation of the process
      • * Use Pharmacovigilance network development
      • * CTRI registration (Public information enabled by CDSCO)
      • * Ethics /Scientific committee approvals (ICMR guide, OHRP Registered?)
    • 62. … More patient PROTECTIVE MEASURES available
      • Protective mechanisms in place to allow continuation of studies:
        • DMC (Data monitoring committee)
        • DMEC (Date monitoring and ethical committee)
        • DSMBs (Date Safety Monitoring Board)
        • Regular and periodic IRB safety reviews
      • So what is missing in Clinical Research today ?
        • Regular surveillance mechanisms from CDSCO and other audit firms
        • Training in medical schools on ethics in EBM
        • Community involvement and awareness of clinical research
        • Patient protection groups (with balanced views)
        • Research societies / specialty bodies (with balanced views)
        • Accreditations for ECs, CROs and CR personnel (various skill sets)
        • Control and register SMOs (many sub-standard ones mushrooming!)
      • Hospitals: Largely no-health care regulations
        • laws for registration in some states
        • no standards set
        • no universal accreditation mechanism
        • proposed national law (awaited)
    • 63.
      • Like in other walks of life,
      • nothing works more than the restraint on the continued temptation
      • to get on to the wrong side of the law to make a quick buck!
      • (Ethics rule our lives, others ruin them !)
      • … so far as the law is around,
      • the police will be around,
      • … so far as the police are around,
      • the criminals will also be around !
      • Is this ANY different in other professions & spheres of life ?
      • … so is only Clinical research profession in a dilemma?!
    • 64.  

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