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Clinical Research and Development in the Pharmaceutical and Biotechnology Industry

Clinical Research and Development in the Pharmaceutical and Biotechnology Industry. Robert Anderson, MHA, CCRA, CCRCP Director, Clinical Trials Administration www.cratraininginstitute.com Houston Texas. Objectives. To understand the drug development process

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Clinical Research and Development in the Pharmaceutical and Biotechnology Industry

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  1. Clinical Research and Development in the Pharmaceutical and Biotechnology Industry Robert Anderson, MHA, CCRA, CCRCP Director, Clinical Trials Administration www.cratraininginstitute.com Houston Texas

  2. Objectives • To understand the drug development process • To understand the phases and components of the clinical research process • To appreciate the history behind the regulations in the clinical development process • To understand the current regulations involved with the clinical research process

  3. Physician InsuranceCompany Patient Care Hospital Pharmaceutical Industry Healthcare Industry Players

  4. Target Selection Target Validation & lead optimization Proof of Concept Clinical Trials Pre-clinicalPhase CompoundSelection Proof of ConceptOutcome 2 – 4 Years 4 – 7 Years Clinical Phases I, IIIII, IIIB* Drug Registration FDA Approval Marketing (Phase IV Clinical Trials) *Key variable guiding development time Marketing Introduction Drug Discovery Process (250) (5,000 – 10,000) (5) (1)

  5. Clinical Trials: What Are They? • An organized research study designed to investigate new methods of preventing, detecting, diagnosing, or treating an illness or disease (such as cancer).

  6. Sponsor InvestigatorSite Patient IRB CRO SMO The Players in Clinical Research

  7. Phase II End of Phase II Meeting Pre-IND Meeting IND Application PhaseI PhaseII Drug Approval Phase III Pre-NDA Meeting PhaseIV File NDA Clinical Trials Process andAssociated Regulatory Process

  8. Phases of Clinical Trials

  9. Tasks Involved to Develop/Support Clinical Trials • Protocol development • Volunteer recruitment • Clinical conduct (management) • Monitoring • Data management • Clinical statistics • Medical writing • Quality assurance

  10. File IND application Sites enroll patients Develop protocolSubmit to FDA for comment or no action Patients cycle through study Capture: Adverse events, vital signs, study drug adherence, QOL questionnaires captured on Case Report Forms Select investigational sites based on # of patients needed for the study Patients exit study • Regulatory requirements for each trial at each site • 1571 or 1572 • PI’s CV • Financial disclosure forms • Informed consent • IRB approval Data collected and cleaned Sites closed Write study report Add study to NDA Initiate site(s) What is Involved in a Clinical Trial?

  11. Clinical Trials Benefits & Risks

  12. Clinical Trial Standard Language

  13. Clinical Trial Standard Language, continued

  14. History Behind Regulations of Clinical Trials • Regulations often result in response to abuse of human research subjects and concerns about the validity of data and conclusions from clinical trials. • The primary vehicles for human subject protection are IRBs and informed consent. • The Declaration of Helsinki and the Belmont Report are critical documents for the protection of human subjects in research. • The FDA, by means of PDUFA and FDAMA, has made significant gains in speeding the process of making new drugs available for patients who need them. • Current problems with clinical trials and trial oversight may well lead to increased regulation.

  15. Regulations for Clinical Trials • The FDA regulations pertaining to clinical trials are found in 21 CFR Parts 11, 50, 54, 56, 312 and 314. • The ICH Guidelines for Good Clinical Practice should be followed in clinical trials. • The FDA publishes many guidelines and information sheets pertaining to the appropriate conduct of clinical trials. • Good clinical practices are the ethical and clinical standard for designing, conducting, analyzing, monitoring and reporting on clinical trials.

  16. Health Outcomes • Health outcomes studies examine the clinical, economic and quality-of-life outcomes of pharmacotherapy. • Health outcomes research expands upon the FDA-mandated efficacy and safety endpoints to give a fuller picture of the outcomes experienced by a patient. It is a relatively new discipline that combines a number of fields of study, including medicine, epidemiology, statistics, economics and psychometrics. • Early in development, companies may be interested in documenting the epidemiology and cost burden of a particular disease state. • As a compound moves through to Phase II and II, behavioral, humanistic and economic endpoints may be incorporated into registration trials. • Concurrently, economic models may be created to quantify the economic benefit of the new therapy. • Once a compound is launched, a variety of research services may be utilized, including registries, Phase IIIb/IV comparative studies and claims analyses.

  17. Other Issues in the Clinical Research Process • National Institutes of Health • Special populations • Data Safety Monitoring Boards • Orphan drugs

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