IDST 1240
Introduction To Clinical Research
Course Description
This course is designed to provide students with a basic understanding of what clinical research is and the scientific principles on which it is based. The course starts with a historical perspective on clinical research and then goes on to explore in detail the following topics: purpose and phases of clinical research, clinical trial development and conduct, ethical and regulatory implications, and the roles and responsibilities of all parties involved in clinical research.
Credits/Modes of Instruction
This is a 3-credit undergraduate course in lecture format that relies on regular activities, assignments, and completion of weekly topics.
Prerequisites
Successful completion of the following two courses: Dynamics of Health Care in Society and Medical Terminology
Instructor
The instructor will be a Rutgers SHRP faculty (or adjunct) member.
Course Goals and Objectives:
Goals
The goal of this course is to provide students with the fundamentals of clinical research focusing on its purpose, development, regulations, and implications in healthcare.
Objectives
After completion of this course, students will be able to:
- Describe the purpose and functions of clinical research and how they have evolved over time.
- Provide a basic explanation of various study designs and utilize this information to evaluate peer-reviewed, published clinical research.
- Discuss how ethics is relevant to clinical research and describe the ethical principles which guide clinical research.
- Describe the regulatory and safety measures in place to protect human subjects in clinical research.
- Identify the various organizations and personnel involved in clinical research and explain their functions and roles.
- Explain how a clinical trial protocol is developed and implemented.
- Discuss the critical role of data management in research and what factors drives this process.
- Describe the processes and entities in place to ensure clinical quality control and drug safety.
Course Requirements
Requirements for Completion
Attendance is required to keep up with the information presented in class. Students will be expected to participate in classroom discussions and group activities. Each course unit will include readings, assignments, and a short quiz. In addition, successful completion of the four course projects will be required. There will be a cumulative final exam based on class content and assigned readings.
Requirements / WeightAttendance/Participation/Group Discussion / 10%
Unit Quizzes / 20%
Unit Assignments/Homework / 10%
Course Projects
· Research Ethics Paper
· Journal Club Presentation
· Clinical Trial Protocol Design
· Careers in Clinical Research Assignment / 40%
Final Examination / 20%
Total / 100%
Evaluation, Feedback and Grading
Evaluation/Assessment Methods
· Attendance/Participation/Group Discussion – Students are expected to attend all classes and participate in classroom discussions and group activities.
· Unit Quizzes: Students will be required to take a short quiz at the completion of each unit. Content will be based on lectures, readings, and classroom discussions/activities.
· Unit Assignments – Each unit will have specific assignments geared to meet unit objectives. These assignments can be completed as homework or in class, as time permits.
· Course Projects – There will be four major projects due throughout the course. Each project will have specific directions for completion and students are expected to work individually on these projects.
· Final Examination – Successful completion of a cumulative final exam at the end of the course is required.
Feedback on Progress
Students will receive feedback on their performance on a regular basis. Quantitative and qualitative feedback will be provided for all assignments, quizzes/tests, and projects.
Grade Determination
The minimum level of satisfactory performance in this course is a ‘C’ or better. To receive a ‘C’ or better, students must first complete ALL course requirements specified above, including meeting the minimum attendance expectation. Based on the evaluations methods and criteria previously described, each requirement is then scored on a 0-100 point scale. The final letter grade is based on the weighted average of all requirements, as specified in the table below.
Upon successful completion of the course students will be eligible to take the Health Science Careers standardized exam to determine college credit.
High school students must attain a C (74) or better to earn college credits.
For Introduction to Clinical Research, the Rutgers grade listed on transcript will be comprised of 75% of the Rutgers SHRP standardized exam grade and 25% of the high school course grade.
Health Science Careers Program
Grading System
Weighted Average of All Requirements / FinalLetter
Grade
94-100 / A
90-93 / A-
87-89 / B+
84-86 / B
80-83 / B-
77-79 / C+
74-76 / C
70-73 / C-
Faculty/Student Honor Code
(Refer to your SHRP Student Handbook at http://shrp.rutgers.edu/current_students/handbook.pdf)
The faculty of Rutgers School of Health Related Professions believe that students must observe and support high standards of honesty and integrity in all aspects of education, practice, and research. For this reason, all matriculated and non-matriculated students in this course are expected to abide by the School's Faculty/Student Honor Code and accept responsibility to help ensure that these standards are maintained by reporting violations of the Honor Code observed in others. All violations will be considered with gravest concern and may be punishable with sanctions as severe as suspension or dismissal.
General Learning Resources
Required Textbook(s):
Jacobsen, Kathryn H. Introduction to Health Research Methods: A Practical Guide. 2012. Jones and Bartlett Learning, 5 Wall Street, Burlington, MA. 2012. (ISBN:13:978-0-7637-8334-1)
Nesbitt, L. Clinical Research: What It Is and How It Works. Boston, MA: Jones and Bartlett Publishers. 2004. (ISBN: 0763731366)
Highly Recommended:
J. Dennis Blessing and J. Glenn Forister. Introduction to the Research and Medical Literature for Health Professions, Third Edition 2013. Jones and Bartlett Learning, 5 Wall Street, Burlington, MA 01803 (ISBN: 978-1-4496-5033-3)
Gallin, J., Ognibene, F. Principles and Practice of Clinical Research, 2nd Edition. Boston, MA: Academic Press/Elsevier. 2007. (ISBN: 9780123694409)
Other Required Learning Resources
Various website links will be provided in the Learning Resources section for each unit in the Course Schedule. Students are required to access these websites for completion of assigned readings and activities.
Course Units/Schedule
Note: this schedule is a plan only, subject to change by the instructor as deemed necessary to achieve the course goals. Whenever possible, you will be notified in advance of any changes, especially those affecting course requirements or grading.
Unit/Begin Date / Topical Outline / Learning Resources / Activities/Assignments
Unit 1 / History of Clinical Research
· Define clinical research
· Explore the evolution of clinical research from the beginnings of civilization.
· Discuss key historical research cases and how they have contributed to advances in medicine and shaped today’s version of the clinical trial.
· Discuss current research. / Read:
· Gallin – Chapter 1: A Historical Perspective on Clinical Research
· The Tuskegee Timeline. Centers for Disease Control and Prevention – US Public Health Service Syphilis Study at Tuskegee - http://www.cdc.gov/tuskegee/timeline.htm
· Research Implications. Centers for Disease Control and Prevention – US Public Health Service Syphilis Study at Tuskegee - http://www.cdc.gov/tuskegee/after.htm
· Jacobsen – Chapter 1
Review/Listen:
· Remembering Tuskegee - Syphilis Study Still Provokes Disbelief, Sadness. Alex Chadwick. National Public Radio (NPR) Report – July 22, 2002 - http://www.npr.org/programs/morning/features/2002/jul/tuskegee/ / Group Classroom Discussion:
Open the class with a discussion of what clinical research is. Explore the students’ perceptions of the following:
-What is the definition of clinical research?
-What is the purpose of clinical research?
- What are the benefits of conducting clinical research?
Optional Lesson Extension:
Movie “Miss Ever’s Boys”
Homework/Assignment:
Complete Review Questions
Complete Unit 1 Quiz
Unit 2 / Overview of Clinical Research
· Know what research is and is not.
· Describe the various types of health research.
· Identify the goals of heath research.
· List and describe the five basic steps of the research process.
· Describe the basic steps of the scientific research process.
· Define clinical research and its purpose.
· Describe various types of research study designs including observational studies and clinical trials.
· Explain the key elements of the four phases of clinical trials.
· Identify the five steps of the research process / Read:
· Nesbitt – Chapter 1
· Understanding Research Study Designs. University of Minnesota – BioMedical Library -
· http://hsl.lib.umn.edu/biomed/help/understanding-research-study-designs LIVE 1/31/2013
· Understanding Clinical Trials. Clinical Trials.gov- National Institutes of Health - http://clinicaltrials.gov/ct2/info/understand#Q01
· Jacobsen - Chapter 1-29 (Pg. 10)
Step one - Chapter 2
Step two - Chapter 6
Step Three - Chapter 15
Step Four - Chapter 25
Step five - Chapter 29
· Blessing – Chapter 1,6,7,8,10,12 / Homework/Assignment: New Terminology
Terms to know: Study Designs
Clinical Study
Interventional Study
Observational Study
Case Control
Case Series
Ecological Study
Aggregate Study
Meta-analysis
Logitudinal Cohort Study
Retroactive Cohort
Cross-sectional
Double-blind Study
Randomized Control Trials
Population Based Research
Complete Unit 2 Quiz
Unit 3 / Ethics in Clinical Research
· Discuss principles of the ethical framework for clinical research: Value and Validity, Fair Subject Selection, Favorable Risk-Benefit Ratio, Independent Review, Informed Consent, and Respect for Enrolled Subjects.
· Describe the purpose of a Patient Informed Consent Form.
· Identify the key information included in Patient Informed Consent forms.
· Explain the role and functions of the Investigational Review Board (IRB). / Read:
· Nesbitt – Chapter 2
· Gallin –
Chapters 2 : Ethical Principals in Clinical Research
Chapter 5: Institutional Review Boards
· Jacobsen – Chapter 21 & 22
· Blessing – Chapter 3.4 / Homework/Assignment:
Complete Review Questions
Terms to Know: Ethics
Value and Validity
Fair Subject Selection
Eligibility Criteria
Inclusion Criteria
Exclusion Criteria
Favorable Risk-Benefit Ratio
Beneficence
Non-maleficence
Justice
Respect for Enrolled Subjects
Independent Review
Informed Consent
Institutional Review Board
OHRP Office of Human
Research Protection
Nuremberg Code
Belmont Report
Complete Unit 3 Quiz
Unit 4 / The Clinical Research Landscape: regulatory agencies, research personnel, research sites, contract research organizations, the pharmaceutical industry
· List the various organizations involved in the development and conduct of a clinical trial.
· Describe the role of the Food and Drug Administration in drug discovery and development.
· Identify key clinical research personnel at the study sites.
· Distinguish between government-sponsored and industry-sponsored clinical research.
· Define the components of the pharmaceutical industry and discuss the challenges under which the components operate. / Read:
· Nesbitt – Chapter 3, 9
· Gallin-
Chapter 9 Data and Safety Monitoring
Chapter 26 (pg. 350-356)
Chapter 37 Pharmaceutical Research
· Jacobsen – Chapter 22
· Blessing – Chapter 11 / Homework/Assignment:
Complete Review Questions
Terms to Know: Research
Principal Author
Principal Investigator
FDA
IRB
Clinical Trial Sponsor
CRO Clinical Research Org
Study Monitors
Terms to Know: Pharmaceutical
(Gallin p 546-550)
Efficacy
Safety
Pharmacovigilance
Fast Track Approval
Placebo
Placebo effect
Complete Unit 4 Quiz
Unit 5 / Clinical Research from the Perspective of the Patient
· Explore the reasons that motivate patients to participate in clinical research.
· Explain why certain populations are underrepresented in clinical trials.
· Describe strategies for effective communication with patients in clinical research and how this can improve the recruitment process as well as retention. / Read:
· Nesbitt – Chapter 7
· Gallin –
Chapter 13 Women and Minorities
Chapter 17 Patient’s Perspective
· Jacobsen – Chapter 19 / Homework/Assignment:
Complete Review Questions
Complete Unit 5 Quiz
Unit 6 / Clinical Trial Protocol and Implementation
· Explain the elements of a clinical trial protocol.
· Develop a concept for a clinical trial and write a protocol concept document to implement it.
· Discuss the processes involved in initiating, maintaining, and closing out a clinical trial. / Read:
· Nesbitt – Chapter 4
Gallin Chapter 32 Writing a Protocol
· Jacobsen – throughout
· Blessing – Chapter 5,9 / Homework/Assignment:
Complete Review Questions
Complete Unit 6 Quiz
Unit 7 / Data Management
· Outline the process of patient data collection in clinical research.
· Explain the importance of effectively monitoring, reviewing, and evaluating patient data.
· Describe various methods of Statistical Analysis
· Describe how the Health Insurance Portability and Accountability Act (HIPAA) regulation applies to research participants. / Read:
· Nesbitt – Chapter 5
· Gallin –
Chapters 7 Food and Drug Administration
Chapter 8: Data Management in Clinical Trials
Chapter 26 Large Clinical Trials and Registries -Clinical Research Institutes
· HIPAA Research Presentation. U.S. Department of Health and Human Services - http://www.hhs.gov/ocr/privacy/hipaa/understanding/training/researchppt.pdf
· Jacobsen Chapter 25
· Blessing – Chapter 14, 15 / Homework/Assignment:
Complete Review Questions
Terms to know: Statistics
Odds Ratio (OR)
Risk Ratio (RR)
Correlation
Prevalence
Terms to know: Data
Validity
Reliability
Quantitative Data
Qualitative Data
Feasibility
Health Insurance Portability and
Accountability Act (HIPAA)
Complete Unit 7 Quiz
Unit 8 / Clinical Quality Control and Assurance
· Explain the purpose and importance of quality management.
· Identify the steps in preparing for an audit.
· Describe the Good Clinical Practice (GCP) guidelines and explain the importance of complying with GCPs in clinical research. / Read:
· Nesbitt – Chapter 5
· Gallin –
Chapters 7 Food and Drug Administration
Chapter 8: Data Management in Clinical Trials
Chapter 26 Large Clinical Trials and Registries-Clinical Research Institutes / Homework/Assignment:
Complete Review Questions
Terms to Know:
Good Clinical Practice (GCP) guidelines
Complete Unit 8 Quiz
Unit 9 / Clinical Drug Safety and Adverse Event Reporting
· Describe what constitutes a Serious Adverse Event (SAE) and identify the appropriate steps for reporting it.
· Discuss the role and functions of Data and Safety Monitoring Boards (DSMB). / Read:
· Gallin – Chapter 6 (page 75)
· Jacobsen – Chapters 13 & 22 / Homework/Assignment:
Complete Review Questions
Terms to Know:Adverse Events
Serious Adverse Event (SAE)
Complete Unit 9 Quiz
Unit 10 / Business of Clinical Research
· Describe what factors to consider when establishing and evaluating clinical study budgets.
· Explain the purpose of a Clinical Trial Agreement and discuss the key elements of this document. / Read:
· Nesbitt – Chapter 8
· Gallin-
Chapter 33 Evaluating a Protocol Budget
· Jacobsen -throughout / Homework/Assignment:
Complete Review Questions
Complete Unit 10 Quiz
Unit 11 / Writing and Publishing in the Health Professions
· Identify what is written in an abstract.
· Identify the types of presentations.
· Understand the need for disseminating one’s research findings.
· Understand how to write a well-prepared research paper and the components of a research paper / Read:
· Jacobsen – Chapter 29 - 35
· Blessing Chapter 18 / Homework/Assignment:
Complete Review Questions
Complete Unit 11 Quiz
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