N117: Introduction to Neuroscience Clinical Trials is taught in Winter Quarter by Professor Joshua Grill.

Josh Grill, Associate Professor, Psychiatry & Human Behavior photo: steve zylius/UCI

Dr. Joshua Grill

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Prerequisite: BIO SCI 99

Course Objective:

This course is open to undergraduate students in the neurosciences. The purpose of the course is to provide an overview of the science of clinical development of treatments
for neurological disease and injury.

After completing this course, students will be able to:
• Describe the purposes and exemplary trial designs for the different phases of drug development
• Identify the essential elements of and develop a clinical trial protocol
• Assess the critical ethical elements of a clinical trial

Sample Syllabus:

# Topic
1

Course overview

  • Syllabus review
  • Protocol development workgroups
  • Testing and grading
2

Introduction to clinical trials

  • A historical perspective
  • Terminology
  • Discussion of protocol development workgroups
3

Essential elements of a clinical trial protocol

  • Asking a question
  • Choosing a population
4

Trial designs

  • Parallel group
  • Cross-over design
  • Non-inferiority
  • Comparative effectiveness
  • Adaptive designs
5

Outcome measurement

  • Purposeful selection
  • The role of surrogates
  • Patient-reported outcomes
  • Challenges
6

Surrogate Endpoints

  • Opportunities
  • Validity
  • Acceptance by regulatory bodies
7

Safety and Trial Monitoring

  • IRBs
  • DSMBs
  • FDA, NIH, and trial sponsors
8

Rational drug development

  • Rational for phase development
  • Implications to Public Health
9

Bias and error

  • Randomization
  • Blinding and concealment
MIDTERM EXAM
10

The role of clinical trials in drug development

  • Phases of Clinical development
  • Learn/Confirm
  • Phase 4
  • New Indications
11

FDA Approval Process

  • Beginning Process
  • Clinical Development Meetings
  • Advisory Committees
  • Timelines
12

The Science of Recruitment and Retention

  • Trial Design Impact on Recruitment
  • Why do patients enroll in clinical trials
  • Interventions to improve recruitment
  • Importance of participation retention
  • Interventions to improve retention
13

Ethics in Clinical Trials

  • Historical Atrocities
  • Ethical Guidelines
  • The role of the IRB
  • Modern Ethical Issues
14

Informed Consent

  • Definition and Purpose
  • Essential Elements
  • Challenges in Brain Disease
15

Delivering Effective Scientific Presentations

  • Organizing your talk
  • Creating Slides
  • Delivery
  • Question and Answer
16

Careers in Clinical Trials

  • Clinician Scientists
  • Statisticians
  • Pharma R&D
  • Trial-Related Industries
17 In-Class Group Presentations I
18 In-Class Group Presentations II
FINAL