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Clinical Trial Process-An Overview PowerPoint Presentation

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Description : Check out this medical PowerPoint presentation titled "Clinical Trial Process: An Overview" by John O. Naim, PhD.

This medical PowerPoint presentation is about clinical trials, scientific studies conducted on human subjects to evaluate the safety and efficacy of new drugs, medical devices, and treatments. The clinical trial process involves several phases and can take several years to complete.

The goal of the clinical trial process is to provide scientific evidence to support the use of new treatments and interventions, and to ensure their safety and effectiveness before they are made available to the public.

Tags : Clinical Trial Process, clinical trials, pharmaceuticals, pharmaceuticals PowerPoint presentations

Published on : Jun 23, 2023 | Views : 1368 | Downloads : 0

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Slide 1-

Clinical Trial Process: An Overview John O. Naim, Ph.D. Director, Clinical Trials Research Unit West Virginia University Mary Babb Randolph Cancer Center
Slide 2-

What Is a Clinical Trial? Effectiveness of intervention to treat a disease Safety of a new drug Defining dose administration Testing drug formulation Exploring combination therapies Evaluating effect of therapies on quality of life
Slide 3-

Types of Clinical Trials Treatment Test new approaches to treat a disease Prevention What approaches can prevent disease Early-detection/screening What are new ways to find hidden disease Diagnostic How can new tests or procedures ID disease
Slide 4-

Phases of Drug Development
Slide 5-

Who are the Players? Human Subject Volunteers Physician Investigators Research Nurses Pharmacists Lab Techs Social Workers Data Managers
Slide 6-

Research Protocol: Roadmap Detailed Research Plan that Includes: Objectives Background and Rationale Subject Selection Criteria Treatment Plan Study Procedures Response Evaluation Criteria Statistical Section
Slide 7-

Human Research is Highly Regulated Code of Federal Regulations (CFR) Title 21- Food and Drugs Part 50 Informed Consent Part 56 IRB Part 312 IND Part 314 NDA Part 600, 6001 Biologics Part 812, 813, 814 Medical Devices Title 45- Public Welfare Part 46 (subparts B, C, D) DHHS, Protection of Human subjects
Slide 8-

What About International Regulation? E6 Good Clinical Practice (GCP): Consolidated Guidance International ethical and scientific quality standard for designing, conducting, recording and reporting trial results.
Slide 9-

Why is Human Research Highly Regulated? Past transgressions lead to the need for laws that protect the rights and welfare of human subjects. Nuremberg Doctors Trial of 1946 (Nuremberg Code) Thalidomide Tragedy (Kefauver-Harris Amendment) Tuskegee Experiments (Belmont Report) Human Radiation Experiments Gene Transfer Experiment
Slide 10-

Informed Consent Learning the key facts about a trial before deciding whether to participate. Research study purpose Risks/Benefits Alternative treatments Confidentiality of records Medical treatment available if injury occurs Whom to contact for answers to questions Statement that participation is voluntary
Slide 11-

Institutional Review Board(IRB) All clinical trials must be approved and monitored by an IRB. IRB is an independent committee of physicians, nurses, statisticians, community advocates and others. The function of the IRB is to ensure that a clinical trial is ethical and the rights welfare of study participants are protected.
Slide 12-

Patient Recruitment Challenge Poor patient recruitment is the number one reason that trials fail. Only 3 to 5 percent of newly diagnosed adult cancer patients participate in a clinical trial. Reasons for this relatively low number are many.
Slide 13-

Recruitment Strategies Physician trust and contact Study staff contact Speaking to community groups Newspaper and radio Ads Internet websites Physician referrals
Slide 14-

Subject Data Collection Data is collected on case report forms (CRF) Much of clinical data is taken from the subjects medical record (source documents) Pharmaceutical and device trials, data is verified by multiple players
Slide 15-

Serious Adverse Events Events that results in any of the following: Death or life-threatening Hospitalization or prolonged hospitalization Persistent or significant disability/incapacity Congenital anomaly/birth defect Events that are serious, unexpected, and related or possibly related to participation in the research must be reported to the Sponsor, FDA and IRB in a timely manner.
Slide 16-

Clinical Trial End Product Ideal: Unambiguous conclusion regarding the clinical outcome of the test treatment/device. Always strive for the ideal, but in most cases have to settle for the best comprise.