Course Proposal: Methods in Clinical Cancer Research - PowerPoint Presentation

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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:

R

esearchers

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 Training

Fall Year 1

Spring Year 1

Summer Year 1

Fall Year 2

Clinical BiostatisticsCore Clinical Research TrainingIndustry/RegulatoryGrants OverviewClinical EpidemiologyMethods in Clinical Cancer ResearchCritical ReviewLeadershipEthicsCancer ImmunologyPrinciples of Cancer Biology (PhD)/Multi. Disc. Clinical Oncology (MD)Methods and Outcomes in Cancer Pop’n SciencesPrinciples 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 Content

Topics

Number of lectures

Cumulative

hours

InstructorTrial Designs and Analysis  Phase I34.5EGM, BrittenPhase II39EGMPhase III313.5EGMPrevention and Control 115AlbergObservational studies116.5WallaceEndpoint selection118

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

Evaluation

Students

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

Other detailsPrerequisites:

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)