COURSE PROPOSAL:METHODS IN CLINICAL CANCER RESEARCH

Primary Instructor: Elizabeth Garrett-Mayer, PhD

Professor of Biostatistics, Dept. of Public Health Sciences

Director of Biostatistics, Hollings Cancer Center

Context: K-12 award• Paul Calabresi Clinical and Translational Oncology

Training Program• Goal: To train successful patient-oriented clinical and

laboratory-based investigators who can work effectively with each other in a collaborative, translational research setting

• Program learning objectives: Researchers will be able to independently design, implement and manage all types of clinical trials with an emphasis on translation of laboratory findings into clinical applications, as well as facilitating laboratory studies aimed at examining the basic mechanisms of poorly understood clinical phenomena.

Didactic TrainingFall Year 1 Spring Year 1 Summer Year 1 Fall Year 2

Clinical BiostatisticsCore Clinical

Research TrainingIndustry/Regulatory Grants Overview

Clinical Epidemiology

Methods in Clinical Cancer Research

Critical Review Leadership

Ethics Cancer Immunology

Principles of Cancer Biology (PhD)/Multi.

Disc. Clinical Oncology (MD)

Methods and Outcomes in Cancer

Pop’n Sciences

Principles of Targeted Drug

Discovery/Translational ’Omics

     

MSCR core courses K-12 courses

Methods in Clinical Cancer Research• Modeled largely after the “Vail” course which is funded by

NCI, AACR, ASCO and industry and started in 1996 to train clinical researchers in oncology.

• Occurs every summer in Vail, CO.• The workshop itself is one week long with didactic

lectures daily (4-8 lectures per day).• Proposed curriculum includes greater detail on trial

design.• Required for K-12 scholars, but open to all students at

MUSC.

Course Objectives

At the end of the course, students should be able to:

• Understand the key components required for designing, activating and implementing a cancer clinical trial.

• Write a proposal for a cancer clinical trial, including objectives, endpoints, trial design, patient population selection, and have some understanding of the required sample size and analytic techniques used to analyze the data at the end of the trial.

• Effectively review and critique clinical trial protocols and published cancer clinical trials research.

Course ContentTopics Number of

lecturesCumulative

hoursInstructor

Trial Designs and Analysis    Phase I 3 4.5 EGM, Britten

Phase II 3 9 EGM

Phase III 3 13.5 EGM

Prevention and Control 1 15 Alberg

Observational studies 1 16.5 Wallace

Endpoint selection 1 18 EGM

Power calculations 1 19.5 EGM

Correlative studies 1 21 EGM

Imaging in clinical trials 1 22.5 Ravenel

Trials in specific treatment modalities 1 24 Warren

Quality of life and other patient reported outcomes 1 25.5 Sterba

Informed Consent 1 27 Stuart/Britten/Lilly

Protocol Review and IRB process 1 28.5 Warren/EGM

Data collection and privacy 1 30 EGM

Trial monitoring and investigator responsibilities 1 31.5 Britten

Grants and mentoring 1 33 Warren

Disparities research 1 34.5 Ford

Protocol review meetings 2 37.5 NA

Journal club discussion** 5 45 EGM

TOTAL 30 45

EvaluationStudents will be graded based on the following components where each assignment is given numeric score, according to the Merit Grades for the MUSC grading system.

• Written reviews of protocols, given as assignments. There will be 3-4 protocols assigned and the review will be structured with particular questions about appropriateness of study design, clarity of the study aims, incorporation of early stopping rules in the trial design, etc. (45% of grade)

• Oral presentation of journal article presenting results of a cancer clinical trial. The article will be selected by the student and Dr. Garrett-Mayer. The student will present to the class an overall summary of the trial and provide a critique of the methods employed. (25% of grade)

• Submitted LOI: The LOI will be submitted twice. First, a draft will be submitted about two-thirds through the course. Dr. Garrett-Mayer will provide feedback. This first draft will constitute 15% of the total grade. The final LOI will be submitted as the ‘final’ and will also count for 15% of the course grade. Total: 30% of grade

The three components will be combined (using the percentages indicated) to arrive at a final merit grade for the course.

Other details• Prerequisites: Consent of the instructor

• Textbooks: None required.

• Suggested texts for reference: • Clinical Trials: A Methodologic Perspective (Piantadosi)• Oncology Clinical Trials (Kelly & Halabi)• Principles of Anti-Cancer Drug Development (Hidalgo, Eckhardt,

Garrett-Mayer, Clendennin)