Clinical Trial Basics

Course Number: 
PABIO 590C
Course Type: 
Methods
Currently Offered: 
Yes
Credits: 
1
Quarter: 
Spring
Weeks: 
6-10
Location: 
UW
Instructor (non-MCB Faculty): 
Feagin, Jean
Class Size: 
20
Course Description: 

This course is intended to convey the scope and complexity of clinical trials, and is appropriate for MPH, MS, and PhD students in biomedical sciences and public health.  Students will learn basic elements of clinical trials: the ethical underpinnings of human subjects research; key elements of trial planning, performance and interpretation; and adaptations needed for international trials. 

Learning Objectives: 

After completing this course, the student will be able to

  • explain the evolution of medical product regulation in the US and internationally.
  • discuss standards for ethical treatment of human subjects.
  • describe key elements of planning and running a clinical trial
  • discuss key issues for international trials.
  • prepare a draft consent form for a clinical trial.
Required Text: 
No textbooks will be used. All course materials will be available on-line, either at the class website, or websites of regulatory agencies or other relevant resources (e.g., FDA, CFR).
Course requirements, examinations and grading: 

Students can choose to take this class for Credit/ No Credit or for a grade.

Quiz/homework (2)                                     30%

Final project (preparing a consent form)    50%

Class participation                                      20%

Lecture topic

Concepts

History and current status of medical product regulation

Event-driven evolution of FDA focus on safety and efficacy;

Laws, regulations, and guidances: definitions and roles in regulation

Pathway to market for different types of medical products (drug, biological, device, combination products).

Ethical basis for use of human subjects

Ethical expectations for human subjects work.

Precipitating events and statement contents for the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.

Lapses and potential for lapses; things are not always black and white.  Importance of  interpreting past events in context (example—the Henrietta Lacks story).

Good Clinical Practices

Planning a clinical trial

Role of Institutional Review Board, required content of consent forms, consenting process.

Trial terminology (e.g., randomization, blinding, placebo, comparison with standard of care, statistical power

Standard vs. adaptive trial design

Running a clinical trial

Trial purposes: testing new product, new indication, new dosage, new target population; usability trials;  enrichment trials;

Defining appropriate endpoints; importance of statistician

Events during a trial:  explain sponsor, site, clinical research staff, monitors, data safety monitoring board

Interactions between site, sponsor, IRB, regulatory agency

Handling adverse events

Trial costs

Regulations and logistics for international trials

Foreign regulatory agencies; key differences from FDA

Harmonization efforts: ICH, GHTF/IMRDF; eCTD, STED

Why do international trials?—population characteristics, testing in desired market

Role of Research Ethics Committees. 

Logistical considerations for international trials

Adaptations for international trials

Adapting for populations with

·       low literacy rates.

·       different knowledge base, e.g., about disease processes.

·       different cultural expectations, e.g., about samples as parts of the body.

·       different societal organization, e.g., who to approach to ask for consent.

Methods Area: 
Cancer Biology
Microbiology, Infection & Immunity