BMTRY 781
Methods
in Clinical Cancer Research
Spring
2015
Description: Didactic lectures will cover the following areas: (1) clinical and
statistical design of phase I, II and III trials; (2) incorporation of correlative
and biomarkers in clinical trials, (3) considerations in chemotherapy, surgery,
radiation and multimodality trials, (4) quality of life and other patient
reported outcomes in cancer research, (5) the protocol review and IRB process,
(6) informed consent, (7) data collection, trial monitoring and investigator
responsibilities, (8) the grants process and mentoring. Other topics are
incorporated as well, (e.g., disparities research). In addition to the didactic
portions of the training, each trainee will have a clinical research proposal
which will be developed into a “letter of intent” (LOI) for a clinical trial.
In addition to the didactic sessions , contact hours
will take the form of a journal club where clinical research papers from
journals such as Clinical Cancer Research or Journal of Clinical Oncology are
discussed, and protocols that are being undertaken at HCC are reviewed and
discussed. Lastly, trainees will also be
required to attend and take part in the HCC Protocol Review Committee’s monthly
meetings (meetings occur every 3 weeks). This will allow the trainees to be
exposed to a variety of studies ranging from Phase I to III cancer trials, in
addition to observational, translational and qualitative research studies.
Trainees will also be encouraged to attend one or more of the HCC Data Safety
and Monitoring Board meetings to gain exposure to issues of trial review and
monitoring.
Course Organization: This course is organized by Dr. Elizabeth
Garrett-Mayer who is also the primary instructor. Some lectures are given by
other faculty members and senior students or fellows as appropriate.
Textbooks: No textbook. Reading material (primarily
found on the web) will be provided as necessary. This will include journal
articles in clinical trial and cancer research journals. Suggested textbooks for reference include:
o
Clinical Trials: A Methodologic Perspective (Piantadosi)
o
Oncology Clinical Trials (Kelly & Halabi)
o
Principles of Anti-Cancer Drug Development (Hidalgo, Eckhardt,
Garrett-Mayer, Clendennin)
Prerequisites: eligible students must satisfy at least one of the following
criteria:
(1)
The student
is enrolled in the MSCR program,
(2)
The student
is a Paul Calabresi K-12 training grant scholar.
(3)
The student
is enrolled in a masters or PhD program in the Dept. of Public Health Sciences
(4)
The
student has received consent of the instructor.
Assessment
of Students: 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.
1) 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)
2) 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)
3) 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
Homeworks Policy:
Homeworks are due by 5pm on the due date. All homeworks should be emailed to the primary instructor (garrettm@musc.edu) or turned in at lecture
time. Asking for extensions on homeworks is strongly
discouraged. However, it is expected that, on occasion, extenuating
circumstances may arise. Therefore, the policy is that each student may request an extension on homework twice and the
extension is to be no more than 2 days. You must notify the primary
instructor that you are requesting an extension before the time the assignment
is due. After using two extensions, no more extensions will be granted except
with a medical note.
Office Hours: The primary instructor will have office hours
by appointment.
Course Objectives: At the end of the course, students should be able to:
1) Understand
the key components required for designing, activating and implementing a cancer
clinical trial.
2) 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.
3) Effectively
review and critique clinical trial protocols and published cancer clinical
trials research.
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Primary Instructor: |
|
Elizabeth Garrett-Mayer |
|
Website: |
|
http://people.musc.edu/~elg26/teaching/statcomputing.2014/statcomputingI.2014.htm |
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Contact Info: |
|
Hollings Cancer Center, Rm 118G garrettm@musc.edu (preferred mode of
contact is email) |
|
Time: |
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Tuesdays and Thursdays, 1:30-3:00pm |
|
Location: |
|
BSB 302 |
|
Office
Hours: |
|
By appointment. Contact via email. |
|
|
|
|
Tentative
Lecture Schedule:
|
Lecture number |
Date |
Topic |
Instructor |
Notes
and links |
|
1 |
Tu Jan 6 |
Introduction |
EGM |
|
|
2 |
Th Jan 8 |
Intro (continued) |
EGM |
|
|
3 |
Tu Jan 13 |
Phase I trials: practical considerations |
EGM |
|
|
4 |
Th Jan 15 |
No class |
|
|
|
5 |
Tu Jan 20 |
Phase I trial designs |
EGM |
|
|
6 |
Th Jan 22 |
Phase I in practice:
current topics/controversies |
EGM |
PressAnnouncement.nivolumumb.pdf |
|
7 |
Tu Jan 27 |
Phase II trials: practical
considerations |
EGM |
|
|
8 |
Th Jan 29 |
No class |
EGM |
|
|
9 |
Tu Feb 3 |
Phase II trial designs |
EGM |
|
|
10 |
Th Feb 5 |
Phase II trials: challenges
for the future (and present) |
EGM |
Improving
Phase II Designs.pptx Note: Phase I
trial review due |
|
11 |
Tu Feb 10 |
Quality of Life and patient
reported outcomes |
Katie Sterba |
|
|
12 |
Th Feb 12 |
Biomarker clinical trial
designs |
EGM |
|
|
13 |
Tu Feb 17 |
Phase III trial designs |
EGM |
|
|
14 |
Th Feb 19 |
Other designs: phase 0, window
of opportunity, Bayesian adaptive. |
EGM |
Ellis.pdf (Matthew
Ellis’ slides) L-3.02-J.Jack-Lee.pdf
(jack lee’s slides) |
|
15 |
Tu Feb 24 |
|
EGM |
|
|
16 |
Th Feb 26 |
Data safety and monitoring |
EGM |
|
|
17 |
Tu Mar 3 |
Endpoint selection issues
/Power calculations |
EGM |
|
|
18 |
Th Mar 5 |
The IRB process: part 1 |
Susan Sonne |
Note: phase II
trial assignment due |
|
19 |
Tu Mar 10 |
Spring break (no class) |
|
|
|
|
Th Mar 12 |
Spring break (no class) |
|
|
|
|
Tu Mar 17 |
Observational studies |
EGM |
|
|
20 |
Th Mar 19 |
The IRB process: part 2 |
Susan Sonne |
(see slides from 3/5/15) |
|
21 |
Tu Mar 24 |
Local protocol process and
the CTO |
Terri Matson |
Methods
in Clinical Cancer Research Class_CTO issues March
2015.pptx |
|
22 |
Th Mar 26 |
Grants and grant writing |
Anita Harrison |
|
|
23 |
Tu Mar 31 |
Disparities research |
Ford |
|
|
24 |
Th Apr 2 |
Prevention and Control
studies |
Kristin Wallace |
|
|
25 |
Tu Apr 7 |
Correlative studies |
EGM |
|
|
26 |
Th Apr 9 |
Tobacco
Cessation in Clinical Cancer Trials |
Graham Warren |
|
|
27 |
Tu Apr 14 |
Radiation and
Multimodality Trials |
Graham Warren |
|
|
28 |
Th Apr 16 |
Imaging Endpoints |
James Ravenel |
|
|
29 |
Tu Apr 21 |
Informed Consent Process |
EGM |
|
|
30 |
Th Apr 23 |
Tissue testing methods |
Laura Spruill |
|
|
31 |
Tu Apr 28 |
Work-Life Balance |
EGM |
Work-Life_Balance_R-Harrison.pdf · Kuerer etal. Career
Satisfaction, Practice Patterns and Burnout among Surgical Oncologists. · Balancing your life at work
and home. Journal of Oncology Practice. · Shanafelt
et al. Shaping your career to maximize personal
satisfaction in the practice of oncology. · Shanafelt. A career in surgical oncology: finding
meaning, balance, and personal satisfaction. · Shanafelt.
Finding meaning, balance and personal satisfaction in the practice of
oncology. |
Homework Assignments:
1) Phase I trial review: Select one of the following protocols (RTOG0017, RTOG0241, Nivolumumab (either final or initial). Fill out review template: PhaseIReview.docx.
Please submit by Thursday, Feb 5
@ 5pm to garrettm@musc.edu.
2) Phase II trial designs:
For
Biostatistics grad students: TrialCharacteristics.PhaseII.docx
For
K-12 scholars/MDs: PhaseIIReview.docx
Please submit by Thursday, Mar 5
@ 5pm to garrettm@musc.edu
3) Phase III trial designs:
For
Biostatistics grad students: HomeworkIII.docx
PRC and
DSMB Schedule, Spring 2015