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Clinical Trial Process to see overall trial.ppt
- 1. Clinical Trial Process:An Clinical Trial Process: An Overview Overview John O. Naim, Ph.D. John O. Naim, Ph.D. Director, Clinical Trials Research Director, Clinical Trials Research Unit Unit West Virginia University West Virginia University Mary Babb Randolph Cancer Center Mary Babb Randolph Cancer Center
- 2. What Is aClinical Trial? What Is a Clinical Trial? Effectiveness of intervention to treat a Effectiveness of intervention to treat a disease disease Safety of a new drug Safety of a new drug Defining dose administration Defining dose administration Testing drug formulation Testing drug formulation Exploring combination therapies Exploring combination therapies Evaluating effect of therapies on quality of Evaluating effect of therapies on quality of life life
- 3. Types of ClinicalTrials Types of Clinical Trials Treatment Treatment – Test new approaches to treat a disease Test new approaches to treat a disease Prevention Prevention – What approaches can prevent disease What approaches can prevent disease Early-detection/screening Early-detection/screening – What are new ways to find hidden disease What are new ways to find hidden disease Diagnostic Diagnostic – How can new tests or procedures ID disease How can new tests or procedures ID disease
- 4. Phases of DrugDevelopment Phases of Drug Development Phase 1 Phase 1 Phase 2 Phase 2 Phase 3 Phase 3 Phase 4 Phase 4 No. of No. of Participants Participants 15-30 15-30 <100 <100 100 to 100 to thousands thousands Several Several hundreds to hundreds to several several thousands thousands Purpose Purpose First in First in humans humans Find safe Find safe dose dose Determine Determine efficacy efficacy Compare Compare new agent new agent with with standard standard treatment treatment Post –market Post –market Long-term Long-term safety and safety and efficacy efficacy
- 5. Who are thePlayers? Who are the Players? Human Subject Volunteers Human Subject Volunteers Physician Investigators Physician Investigators Research Nurses Research Nurses Pharmacists Pharmacists Lab Techs Lab Techs Social Workers Social Workers Data Managers Data Managers
- 6. Research Protocol: Roadmap ResearchProtocol: Roadmap Detailed Research Plan that Includes: Detailed Research Plan that Includes: – Objectives Objectives – Background and Rationale Background and Rationale – Subject Selection Criteria Subject Selection Criteria – Treatment Plan Treatment Plan – Study Procedures Study Procedures – Response Evaluation Criteria Response Evaluation Criteria – Statistical Section Statistical Section
- 7. Human Research isHighly Human Research is Highly Regulated Regulated Code of Federal Regulations (CFR) Code of Federal Regulations (CFR) – Title 21- Food and Drugs Title 21- Food and Drugs » Part 50 Informed Consent Part 50 Informed Consent » Part 56 IRB Part 56 IRB » Part 312 IND Part 312 IND » Part 314 NDA Part 314 NDA » Part 600, 6001 Biologics Part 600, 6001 Biologics » Part 812, 813, 814 Medical Devices Part 812, 813, 814 Medical Devices – Title 45- Public Welfare Title 45- Public Welfare » Part 46 Part 46 (subparts B, C, D) (subparts B, C, D) DHHS, Protection of Human subjects DHHS, Protection of Human subjects
- 8. What About International WhatAbout International Regulation? Regulation? E6 Good Clinical Practice (GCP): E6 Good Clinical Practice (GCP): Consolidated Guidance Consolidated Guidance – International ethical and scientific quality International ethical and scientific quality standard for designing, conducting, recording standard for designing, conducting, recording and reporting trial results. and reporting trial results.
- 9. Why is HumanResearch Highly Why is Human Research Highly Regulated? Regulated? Past transgressions lead to the need for laws Past transgressions lead to the need for laws that protect the rights and welfare of human that protect the rights and welfare of human subjects. subjects. – Nuremberg Doctors Trial of 1946 (Nuremberg Code) Nuremberg Doctors Trial of 1946 (Nuremberg Code) – Thalidomide Tragedy (Kefauver-Harris Amendment) Thalidomide Tragedy (Kefauver-Harris Amendment) – Tuskegee Experiments (Belmont Report) Tuskegee Experiments (Belmont Report) – Human Radiation Experiments Human Radiation Experiments – Gene Transfer Experiment Gene Transfer Experiment
- 10. Informed Consent Informed Consent Learning the key facts about a trial Learning the key facts about a trial before before deciding whether to participate. deciding whether to participate. – Research study purpose Research study purpose – Risks/Benefits Risks/Benefits – Alternative treatments Alternative treatments – Confidentiality of records Confidentiality of records – Medical treatment available if injury occurs Medical treatment available if injury occurs – Whom to contact for answers to questions Whom to contact for answers to questions – Statement that participation is Statement that participation is voluntary voluntary
- 11. Institutional Review Board InstitutionalReview Board (IRB) (IRB) All clinical trials must be approved and All clinical trials must be approved and monitored by an IRB. monitored by an IRB. IRB is an independent committee of IRB is an independent committee of physicians, nurses, statisticians, community physicians, nurses, statisticians, community advocates and others. advocates and others. The function of the IRB is to ensure that a The function of the IRB is to ensure that a clinical trial is ethical and the rights welfare clinical trial is ethical and the rights welfare of study participants are protected. of study participants are protected.
- 12. Patient Recruitment Challenge PatientRecruitment Challenge Poor patient recruitment is the number one Poor patient recruitment is the number one reason that trials fail. reason that trials fail. Only 3 to 5 percent of newly diagnosed Only 3 to 5 percent of newly diagnosed adult cancer patients participate in a clinical adult cancer patients participate in a clinical trial. trial. Reasons for this relatively low number are Reasons for this relatively low number are many. many.
- 13. Recruitment Strategies Recruitment Strategies Physician trust and contact Physician trust and contact Study staff contact Study staff contact Speaking to community groups Speaking to community groups Newspaper and radio Ads Newspaper and radio Ads Internet websites Internet websites Physician referrals Physician referrals
- 14. Subject Data Collection SubjectData Collection Data is collected on case report forms Data is collected on case report forms (CRF) (CRF) Much of clinical data is taken from the Much of clinical data is taken from the subjects medical record (source documents) subjects medical record (source documents) Pharmaceutical and device trials, data is Pharmaceutical and device trials, data is verified by multiple players verified by multiple players
- 15. Serious Adverse Events SeriousAdverse Events Events that results in any of the following: Events that results in any of the following: – Death or life-threatening Death or life-threatening – Hospitalization or prolonged hospitalization Hospitalization or prolonged hospitalization – Persistent or significant disability/incapacity Persistent or significant disability/incapacity – Congenital anomaly/birth defect Congenital anomaly/birth defect Events that are serious, unexpected, and Events that are serious, unexpected, and related or possibly related to participation in related or possibly related to participation in the research must be reported to the the research must be reported to the Sponsor, FDA and IRB in a timely manner. Sponsor, FDA and IRB in a timely manner.
- 16. Clinical Trial EndProduct Clinical Trial End Product Ideal: Unambiguous conclusion regarding Ideal: Unambiguous conclusion regarding the clinical outcome of the test the clinical outcome of the test treatment/device. treatment/device. Always strive for the ideal, but in most Always strive for the ideal, but in most cases have to settle for the best comprise. cases have to settle for the best comprise.