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.
  • Careers In Clinical Research Industry Gp 06 Nov11

    1. 1. A quick road map Gopal Pai, Ph.D. Head, Clinical Operations, Clinigene International Limited (A Biocon Company), Bangalore
    2. 2. Out-sourced / In-sourced / Combination Customer Focus Respect for People Integrity Innovation Teamwork Leadership Performance Community
    3. 7. In Vitro Screening Tests
    4. 8. In Vitro Screening Tests Animal Model Screening Tests
    5. 9. In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Animal Toxicity Studies
    6. 10. In Vitro Screening Tests Animal Model Screening Tests Pre-clinical Toxicity Studies Sub-Acute & Acute Chronic Animal Safety Studies
    7. 11. Sub-Acute, Acute & Chronic Animal Safety Studies <ul><li>Reproductive </li></ul><ul><li>Fertility </li></ul><ul><li>Fetal </li></ul><ul><li>Perinatal </li></ul><ul><li>Post-natal </li></ul><ul><li>Carcinogenicity </li></ul><ul><li>Teratogenicity </li></ul><ul><li>Mutagenicity </li></ul><ul><li>Topical toxicity </li></ul>
    8. 12. Acute Sub-Acute & Chronic Animal Safety Studies Pharmaceutical Development <ul><li>Preformulation </li></ul><ul><li>Formulation </li></ul><ul><li>Process development </li></ul><ul><li>Stability & shelf-life </li></ul><ul><li>Scale-up </li></ul>
    9. 13. Acute & Sub-Acute Chronic Animal Safety Studies Pharmaceutical Development Clinical Development
    10. 14. <ul><li>Biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. </li></ul><ul><li>Tests the drug for its efficacy and toxicity in humans </li></ul><ul><li>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. </li></ul>
    11. 15. Clinical Development Phase I Phase II Phase III Phase IV <ul><li>Marketing permission </li></ul><ul><li>New indications </li></ul><ul><li>Post-marketing surveillance (PMS) </li></ul><ul><li>Pharmacoepidemiology </li></ul><ul><li>Pharmacoeconomics </li></ul><ul><li>Pharmacovigilance </li></ul><ul><li>Risk complexity </li></ul><ul><li>Scientific rigor </li></ul>
    12. 16. <ul><li>First trials of drugs in humans (healthy volunteers) </li></ul><ul><li>Preliminary evaluation of safety & toxicity </li></ul><ul><li>Establishes pharmacokinetic and pharmacodynamic profile </li></ul><ul><li>Various dosage forms/strengths may be tested </li></ul><ul><li>Limited number of volunteers are usually used (12-32) </li></ul>
    13. 17. <ul><li>Establishes efficacy for proposed diseases or conditions </li></ul><ul><li>Assesses short term safety </li></ul><ul><li>Determines appropriate route of administration, dose range & frequency </li></ul><ul><li>Small number of subjects (generally exceeding 24-30 subjects) </li></ul>
    14. 18. <ul><li>Large scale trials to obtain efficacy & safety data </li></ul><ul><li>Evaluates the therapeutic values of drug </li></ul><ul><li>May also involve differentiation from other existing therapies </li></ul><ul><li>Establish pharmaco-economic importance </li></ul><ul><li>Generally comparative studies are common </li></ul><ul><li>Number of subjects could exceed 300 </li></ul>
    15. 19. <ul><li>Conducted after the drug route, dose & frequency are established </li></ul><ul><li>Studies performed according to approved labeling only </li></ul><ul><li>Post-marketing surveillance (safety/toxicity) </li></ul><ul><li>To differentiate from other existing therapies </li></ul><ul><li>Pharmacoeconomic evaluation </li></ul><ul><li>Increase usage and awareness in practice </li></ul><ul><li>Range exceeds 1000 subjects </li></ul>
    16. 20. International Scientific & Ethical quality Standard DESIGN REPORT RECORD COLLECT Patient Safety Credibility of Data Execute Verify Analyze Publish / market Services Audits & Inspections
    17. 21. Declaration of Helsinki ICH-GCP Local regulations Protocol, SOPs
    18. 22. <ul><li>Conduct of study per Declaration of Helsinki, GCP and applicable local regulations </li></ul><ul><li>Research, only if benefits justify risks </li></ul><ul><li>Focus on Patients rights & Safety </li></ul><ul><li>Adequate supporting information </li></ul><ul><li>Scientifically sound protocol </li></ul><ul><li>EC approval </li></ul><ul><li>Medical care of subjects by physician </li></ul><ul><li>Training </li></ul><ul><li>Informed Consent </li></ul><ul><li>Recording & storing of information </li></ul><ul><li>Confidentiality of subjects </li></ul><ul><li>Supplies in conformity with GMP, Protocol </li></ul><ul><li>Quality systems </li></ul>
    19. 24. CR Training Institute
    20. 25. <ul><li>choose a specialty </li></ul><ul><li>like academics </li></ul><ul><li>possesses some industry experience </li></ul><ul><li>understand and appreciate the difference in academic and industrial standards of CR </li></ul><ul><li>skills of teaching and motivating students </li></ul>
    21. 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
    22. 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
    23. 28. Hospital / Institute Investigator Contract Research Organization Sponsor
    24. 29. <ul><li>Highly Experienced & skilled researchers </li></ul><ul><li>clinical scientists, clinicians </li></ul><ul><li>project planners, market researchers </li></ul><ul><li>Voracious readers and analyzers </li></ul><ul><li>Forward thinkers </li></ul><ul><li>Converting theory into practice </li></ul>Product development team Very senior positions (MD, PhD or higher) Synopsis Reg. approval pre-study inv. meet Idea Idea
    25. 30. <ul><li>Experienced </li></ul><ul><li>clinical scientists, clinicians </li></ul><ul><li>project planners, clinical writers, statisticians </li></ul><ul><li>Voracious readers and writers </li></ul><ul><li>Forward thinkers </li></ul><ul><li>Converting theory into practice </li></ul>Dept: Clinical Writing Junior – Senior positions (min. Masters/ PhD) Synopsis Regulatory approval Idea Idea
    26. 31. <ul><li>Experienced </li></ul><ul><li>Regulatory specialists / writers </li></ul><ul><li>(needs knowledge of international drug and CR laws in various countries) </li></ul><ul><li>Specialized in understanding and strategizing </li></ul><ul><li>Liaison with drug and health authorities </li></ul><ul><li>Liaison with academecians and practitioners </li></ul><ul><li>Compile submissions for regulatory authorities </li></ul>Dept: Regulatory Affairs Junior - Senior positions Min: Sc/Ph G/PG Synopsis Regulatory Strategies & approval Idea Idea
    27. 32. <ul><li>Experienced </li></ul><ul><li>clinical specialists / writers </li></ul><ul><li>(needs team skills and negotiation skills) </li></ul><ul><li>Specialized in understanding and strategizing </li></ul><ul><li>Liaison with other specialities and departments </li></ul><ul><li>good team player and negotiator </li></ul><ul><li>good clinical writing skills & experience </li></ul>Dept: Clinical Writing Junior - Senior positions Min: Sc/Ph PG Final Protocol Final CRF Drug Supply Inv. & site selection
    28. 33. <ul><li>Experienced </li></ul><ul><li>IT professionals in CRF designing and forms </li></ul><ul><li>(needs team skills and negotiation skills) </li></ul><ul><li>specialized in layout and designing forms </li></ul><ul><li>expert in flow of data collection instruments </li></ul><ul><li>understanding of database and data validation rules </li></ul><ul><li>good team player and negotiator </li></ul><ul><li>good IT skills & experience </li></ul>Dept: Data Management Junior - Senior positions Min: G/PG (IT specialists) Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    29. 34. <ul><li>Pharma mfg (cGMP), storage & distribution </li></ul><ul><li>Experience in packaging and labeling </li></ul><ul><li>Experience in randomization and blinding supplies </li></ul><ul><li>specialized manufacturing in cGMP for CR supplies </li></ul><ul><li>knowledge of inventory management </li></ul><ul><li>storage & distribution logistics management </li></ul><ul><li>specialization in randomization and blinding techniques </li></ul>Dept: Clinical supplies Junior - Senior positions Min: Pharm/B.tech G/PG Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    30. 35. <ul><li>Experienced Project managers </li></ul><ul><li>Regulatory documentation specialists </li></ul><ul><li>Site start-up specialists / site auditors </li></ul><ul><li>knowledge of infrastructure and capabilities mapping </li></ul><ul><li>knowledge of GCP documentation requirements </li></ul><ul><li>thorough with GCP compliance and medical records </li></ul><ul><li>detection of deficiencies and negotiation skills </li></ul><ul><li>requires travel about 50-60% </li></ul>Dept: Investigator services Junior - Senior positions Min: G/PG (Bio) Final Protocol Final CRF/ eCRFs Drug Supply Inv. & site selection
    31. 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
    32. 37. <ul><li>Project managers </li></ul><ul><li>Clinical Research Associates </li></ul><ul><li>specialized in setting up sites for projects </li></ul><ul><li>assessing sites for GCP compliance, facilities and capabilities </li></ul><ul><li>training site staff for implementation of protocol requirements </li></ul><ul><li>helping site staff to upgrade documentation skills </li></ul><ul><li>help understanding of protocol logically & scientifically </li></ul><ul><li>helper, supervisor, negotiator, motivator </li></ul>Dept: Clinical Operations Junior - Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    33. 38. <ul><li>Clinical Research Associates </li></ul><ul><li>helper, supervisor, negotiator, motivator </li></ul><ul><li>takes care of staff changes and ongoing training </li></ul><ul><li>continued assessment for </li></ul><ul><ul><li>GCP, ethical and protocol compliance </li></ul></ul><ul><ul><li>authenticity of data collection </li></ul></ul><ul><ul><li>facilities and capabilities </li></ul></ul><ul><ul><li>training site staff (turn-over) </li></ul></ul><ul><ul><li>travel 75-85% </li></ul></ul>Dept: Clinical Operations Junior - Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits & Govt. inspection
    34. 39. <ul><li>Internal auditor </li></ul><ul><li>(generalist and experienced) </li></ul><ul><li>independent observer & reporter </li></ul><ul><li>assesses the compliance to </li></ul><ul><ul><li>standard operating procedures (SOP) </li></ul></ul><ul><ul><li>GCP, ethical and protocol compliance </li></ul></ul><ul><ul><li>quality of monitoring by study team </li></ul></ul><ul><ul><li>Verify data generation, facilities, capabilities </li></ul></ul><ul><ul><li>training site staff (turn-over) </li></ul></ul><ul><ul><li>travel 60-75% </li></ul></ul>Dept: Quality Assurance / Govt drug inspector Senior positions Min: G/PG (Bio) Inv. Meet & Ethics Committees Site Initiation Monitoring Quality Audits / Govt. inspection
    35. 40. <ul><li>Medical officer / Safety officer </li></ul><ul><li>(experienced) </li></ul><ul><li>medical terminology & knowledge </li></ul><ul><li>assesses the safety of all participating subjects </li></ul><ul><ul><li>follow regulatory reporting guidelines </li></ul></ul><ul><ul><li>follow up and manage AE / SAEs </li></ul></ul><ul><ul><li>make medical decisions on continuation of subjects </li></ul></ul><ul><ul><li>make medical decisions on continuation of protocol </li></ul></ul><ul><ul><li>documentation requirements </li></ul></ul><ul><ul><li>analysis skills in drug development </li></ul></ul>Dept: Drug Safety / Pharmacovigilance Junior - Senior positions Min: MD / G/PG (Bio) Final Report Safety Monitoring Data processing & analysis Close-out
    36. 41. <ul><li>Database designer / Database programmer </li></ul><ul><li>Data entry / Data manager / Medical coders </li></ul><ul><li>(experienced) </li></ul><ul><li>IT specialists </li></ul><ul><ul><li>(range : computer operator – programmers) </li></ul></ul><ul><li>Database (generally clinical Oracle / Oracle </li></ul><ul><ul><li>system admin, database builder, database programming </li></ul></ul><ul><ul><li>web-page programmers and linking databases </li></ul></ul><ul><li>Data entry </li></ul><ul><ul><li>basic keyboard, medical terminology skills </li></ul></ul>Dept: Data management (Database team) Junior - Senior positions Min: IT skills (G) + nursing Final Report Safety Monitoring Data processing & analysis Close-out
    37. 42. <ul><li>Data manager / Medical coders </li></ul><ul><li>IT specialists (range : database programmers ) </li></ul><ul><ul><li>Knowledge of CDISC standards </li></ul></ul><ul><ul><li>Knowledge of programming </li></ul></ul><ul><ul><li>validation of the database structure </li></ul></ul><ul><ul><li>validation of edit check programs </li></ul></ul><ul><li>Medical knowledge with IT skills </li></ul><ul><ul><li>knowledge of WHO / Medra dictionary </li></ul></ul><ul><ul><li>mapping of diverse terms to standard terms </li></ul></ul>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
    38. 43. <ul><li>SAS programmers / Biometricians </li></ul><ul><li>IT specialists (range : SAS programmers ) </li></ul><ul><ul><li>Knowledge of CDISC standards </li></ul></ul><ul><ul><li>Knowledge of programming & validations </li></ul></ul><ul><ul><li>Generation of tables and listings </li></ul></ul><ul><li>Biometrics knowledge with IT skills </li></ul><ul><ul><li>generate a Statistical Analysis plan </li></ul></ul><ul><ul><li>decide methods and validate programs </li></ul></ul><ul><ul><li>approve tables and listings generated </li></ul></ul>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
    39. 44. <ul><li>Data managers & CRAs </li></ul><ul><li>Generate queries </li></ul><ul><ul><ul><li>Clean database for database lock and release for analysis </li></ul></ul></ul><ul><ul><ul><li>Generation of Final tables and listings (100% accurate) </li></ul></ul></ul><ul><li>Resolve queries </li></ul><ul><ul><ul><li>Help resolve queries and verify data at site </li></ul></ul></ul><ul><ul><ul><li>Collection of essential documents </li></ul></ul></ul><ul><ul><ul><li>Close site </li></ul></ul></ul>Final Report Safety Monitoring Data processing & analysis Close-out
    40. 45. <ul><li>Clinical Writers / Medical Advisors / Project Managers / Biometricians </li></ul><ul><li>use Final tables & listings for reports/publications </li></ul><ul><li>have a good knowledge of regulatory submission requirements internationally </li></ul><ul><li>analytical skills to interpret data and make conclusions </li></ul><ul><li>data organization, language and writing skills </li></ul>Final Report Safety Monitoring Data processing & analysis Close-out
    41. 46. <ul><li>Clinical writers </li></ul><ul><ul><li>SOP writing and administration (re/training, implementation and archival) </li></ul></ul><ul><li>Project Management </li></ul><ul><ul><li>Tracking large projects with MS-Projects (Gantt charts, critical path and mile stones) </li></ul></ul><ul><ul><li>Productivity and resourcing (use of timesheets, costs, tasks and activities, P&L for each project) </li></ul></ul><ul><ul><li>Financial tracking (Project finance) </li></ul></ul><ul><li>Legal & Contracts mgmt (vendors and sites) </li></ul>
    42. 47. <ul><li>CRF / label printing & QA </li></ul><ul><li>Central Laboratory business </li></ul><ul><li>Business development </li></ul><ul><li>IVRS </li></ul><ul><li>Translations </li></ul><ul><li>Rater training and certifications </li></ul><ul><li>GCP training and certification </li></ul><ul><li>Consultant …… </li></ul>
    43. 48. Pull Push <ul><li>Team members </li></ul><ul><li>Competencies </li></ul><ul><li>Systems Processes </li></ul>Push
    44. 51. CHALLENGES IN DRUG DEVELOPMENT GLOBALLY
    45. 55. Once a very noble profession……
    46. 56. <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 ?!
    47. 57. … NOW PERCEIVED AS A GUINEA PIG SYNDROME ! Help !!! Help !!!
    48. 58. Pre-World War II Empiric Rx Evidence-Based Medicine Personalized Medicine Post-World War II … the future?
    49. 59. 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. “ Art” factor
    50. 61. <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>
    51. 62. … 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>
    52. 63. <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 professions & spheres of life ? </li></ul><ul><li>… so is only Clinical research profession in a dilemma?! </li></ul>

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