Course Name: Clinical Research

                                                                                                                       Course Outline:

1.      Introductions:  

·         Define clinical research, human subject research- Federal definition

·          Overview of formats/disciplines for clinical research

2.      Historical Case Studies in Human Subject Research; Ethical Considerations:

·         Discuss articles brought in about clinical trials: are they or aren’t they “research”

·         Historical Case Studies: Tuskegee Experiments, Thalidomide, Jewish Chronic Disease, Willowbrook, San Antonio Contraception, Jesse Hellinger, etc.

·         President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research

·         National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

3.      Developing Ethical Research Principles, regulations, guidelines:

·         Nuremberg Code 1949

·         National Research Act 1974/81 (DHHS 45CFR46)

·         Declaration of Helsinki 1975

·         Belmont Report 1979

·         FDA (21CFR50/56)

·         Common Rule definition, applications

·         Definitions of the Basic Ethical Research Principles

4.      Development of Institutional Review Boards, Data Safety Monitoring Boards, Ethical Review Committees:

·         Dept. Health & Human Services

·         Office of Human Research Protections; Federal Research Oversight

·         Institutional Review Board; roles, responsibilities, membership

·         Data Safety Monitoring Boards; roles, responsibilities

·         Clinical research approval processes, types and organizational structures

5.      Overview of basic designs and formats of human subject research:

·         Quantitative methodologies

·         Qualitative methodologies

·         Descriptive designs; longitudinal, cross-sectional, etc.

·         Correlational designs; predictive, module testing, etc.

·         Quasi-experimental; control group, interrupted time series, etc.

·         Experimental; randomized, factorial, crossover, etc.

·         Non-traditional; primary prevention, health promotion, meta-analysis

6.      Basic Informed Consent Regulations:

·         Federal/international regulations

·         Basic required elements of ICF

·         Local IRB sample wordings, requirements

·         Examples of good & improvement needed ICF’s

·         HIPAA

7.  Overview of Current Federal, State Regulatory agencies for research; roles & areas of oversight:                                                                                                                                                                                                 

·         Office of Inspector General

·         Office of Human Research Protections

·         National Institutes of Health/ Dept. of Health & Human Services

·         Federal Drug Administration

·         State applicable regulations

8.       Defining the Research Team; roles, responsibilities, org. structure:    

·         Principal Investigator, Co-PI, Sub-PI

·         Medical officer/writer

·         CRC, technicians

·         Research Pharmacist

·         Statistician

·         Regulatory manager, monitor/auditor

·         Data manager

·         Scientific writer/publisher

9.       Research Affiliations:                                                    

·         Pharmaceutical, biotech and medical device companies

·         Contract Research Organizations, SMO’s, C-COPS

·          DSMB

·         Funding entities

·         Institutional research organization/ investigative sites

·         Community, academic, multi-sites, independent, cooperatives, international

·         Research laboratories

·         Affiliation Identify professional research associations and their respective roles

                                                                    i.      Society of Clinical Research Associates

                                                                  ii.      Association of Clinical Research Professional

                                                                iii.      Drug Information Association

                                                                iv.      Regulatory Affairs Professional Society

·         IRB Forum-internet

10.  Good Clinical Practice Guidelines (GCP) and International Committee on Harmonization (ICH) Guidelines:                  

·         GCP & ICH historical development

·         Review of guidelines GCP & ICH

·         International verses US research guideline differences

·         Current US & international issues

11.  Clinical Trial Development Phases:            

·         Defining phases 1-4, post marketing

·         New drug development and marketing approval process

·         Drug, device, biologic, radio-logic development considerations

·         Clinical trial originations: Federal, sponsor, PI, WHO, etc

12.   Regulations In Clinical Research 

·         Evolution and History of Regulations in Clinical Research

·         Patents US Regulatory Structure, IND, NDA, ANDA

·         Post Drug Approval Activities, PMS

·         FDA Audits and Inspections

·         EURegulatory Affairs

·         EMEA Organization and Function

·         INDIAN Regulatory system

·         Schedule Y- Rules and Regulations

13.  Biostatistics And Data Management  

·          Importance of statistics in clinical research

·         Statistical considerations at the design, analysis and reporting stage.

·          Data management

·         Data validation

·         SAE reconciliation

·         Query management

·         Software considerations

14.   Clinical Research Methodology  

·         Designing of Protocol,

·         Case Report Form (CRF)

·         Electronic case Report Form (e-CRF)

·         Investigator Brochure (IB)

·         Standard Operating Procedure (SOP)

·         Pharmaco-epidemiology

·         BA/BE Studies

·         Report writing

·         Publication