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Research Pharmacy

Research Pharmacy. Yesterday, today, and tomorrow. Goals of this presentation :. A look at clinical research from a pharmacy point of view. What will NOT be a focus of this presentation: Social and ethical questions and considerations Legal and regulatory issues

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Research Pharmacy

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  1. Research Pharmacy Yesterday, today, and tomorrow

  2. Goals of this presentation : • A look at clinical research from a pharmacy point of view. • What will NOT be a focus of this presentation: • Social and ethical questions and considerations • Legal and regulatory issues • Protocol development and IND applications • Statistical considerations in clinical trials

  3. Why do we do research? Improve patient health through improved patient care • Types of studies: • Observational: e.g. epidemiologic, cohort, case control, longitudinal, etc • Interventional

  4. Interventional clinical trials • Clinical trials allow us to evaluate the efficacy and safety of new medications or agents • Usually in comparison to an established standard of care • Randomized, double-blind studies (the “Gold Standard”)

  5. Why do we do interventional clinical trials? • To obtain data to present to the FDA ! Drug companies are trading drug (and medical care) for data on patient outcomes

  6. Stages in drug development • Drug discovery / development • Pre-clinical testing • Investigational New Drug application (IND) • Clinical testing • Phase I • Phase II • Phase III • Phase IV

  7. Phase I trials • First use of a new drug in humans • Small numbers of patients, usually healthy volunteers • Looking primarily at safety and dose determination • Safety – dose limiting toxicity (DLT) • Dose determination – increase dose to toxicity • Pharmacokinetic and pharmacodynamic studies

  8. Phase II trials • Determine short-term risks and safety • Looking at effectiveness and best tolerated dose level • Dose(s) based on information from Phase I studies • Also looking at side effects • Study subjects are the types of patients the agent is intended to treat

  9. Phase III • Large scale trials (e.g. 300 – 1000+ subjects) looking at safety and efficacy usually in a randomized, controlled fashion often involving multiple centers • Seek to assess risk/benefit ratio and gather date for FDA approval of the agent / labeling • If data gathered from Phase I, Phase II, and Phase III trials demonstrate safety and efficacy => New Drug Application (NDA) may be filed with the FDA

  10. Phase IV trials • Post approval studies • May be required as a condition of approval • Long term safety studies • Comparison studies

  11. Important elements in clinical trials • The protocol • The informed consent • Regulatory bodies • Blinding • Randomization • Finance

  12. The Study Protocol • Common elements: • Title • Protocol summary or synopsis • Background and rationale • Study design / investigational plan • Randomization and blinding • The investigational product • Inclusion and exclusion criteria • Adverse events • Data analysis

  13. Informed Consent Form (the ICF) • Background • Elements • Description of trial • Voluntariness / withdrawal of consent / alternatives • Risk / benefit ratio • Questions • Contacts • Signatures

  14. Regulatory bodies • Institutional review board (IRB) – patient protection • Institutional bio-safety committee (IBC) and the Recombinant DNA Advisory Committee (RAC) • Food and drug administration (FDA) • Compliance office / office of research integrity (ORI)

  15. Blinding • Single vs double blind • Physical blinding: Size, shape, taste, appearance, smell, etc. • Time considerations • Double dummy designs

  16. Randomization • History • IVR and IWR systems • Stratification • Blocks

  17. Finance • Contracts and grants (OCGM) • Cost of doing a study • Conflict of interest concerns

  18. The “Players” • Patients • The PI (and sub I’s), the 1572 form (Statement of Investigator) • Monitors • Research Coordinators • Regulatory entities (IRB, IBC, FDA, ORI / compliance, etc) • CRO’s

  19. The “Players” (continued) • Support services • Laboratory • Radiology • Pharmacy • Statistics • Finance

  20. In the beginning… • “What’s this and where did it come from?” (x2) • “…and you’re also in charge of investigational drugs.” • “I think it’s in that cabinet over there next to the sink” • “We are missing a week’s worth of entries on the temp record.” • “Is this the next envelope?” • “I’m going to San Diego for a meeting!” • “Budgets???”

  21. The present • Personnel • Types of studies • Training • Records and documentation • Monitoring • Disposal of study materials

  22. Elements of a Research Pharmacy • Personnel • Storage space / equipment • Temperature monitoring • Documentation / record retention • The “information sheet” or “summary sheet” • Study budget

  23. Pharmacy study budgets • Common Elements • Start-up • Maintenance • Randomization • Study drug preparation and dispensing • Close-out fee • On – call fees

  24. What’s ahead? • Why utilize pharmacy services? • Exotic agents • Electronic data capture and records • Impact of healthcare systems • Community based research

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