Clinical Pharmacology Subcommittee Report
for the 2005 Department of Biostatistics Faculty Retreat
February 8, 2005 (revised 2/7/05)
Byrne, Harrell, Schildcrout, Yu, Zhu
Key Recommendations:
1. Recruit several biostatisticians with the following skills:
- ≥ 10 years of experience in clinical research data analysis
- “User friendly,” good communicators and teachers
- Able to provide excellent biostatistical support for site visits
- Fluent with both traditional and genetic statistical methods
- Similar to Shyr and Byrne
- Interested in consistently supporting clinpharm so that he or she picks up the biology
rapidly
- Has the ability to provide good support on grant applications
2. Create a biostatistics course for the fellows not enrolled in the MSCI program:
- 20 of 24 fellows receive no formal biostatistical training.
- New Division Chief (Dr. Morrow) is revamping the training.
- Many mentors do not send fellows to MSCI due to time commitment.
- Need for training that allows fellows to conduct research.
- Suggest 2-hour sessions, twice per week for 4 months (60 hrs total).
(e.g., Monday and Wednesday from 3-5.PM).
- Content = MSCI Biostatistics I and Medical Writing for Clinical Investigators.
- Make the course a requirement. Fellows must pass final exam similar to MSCI course.
3. Create a method of biostatistical training for Clin Pharm faculty.
- Need for continuing education in state-of-the-art biostatistical methods.
- Faculty will want training without the fellows involved.
4. Provide internal review of grants and publications.
Grants – internal biostatistics “study section” to identify weaknesses and
strengthen grants.
Publications – Internal biostatistical review to identify potential reasons for rejection and
provide second opinion. They tend to do their own analyses. If they had
biostatisticians more involved in their daily research, internal peer review would
be more fluid.
5. Provide mentoring to newly hired biostatisticians in grant writing, publishing, genetic methods,
and general medical topics (PCR, nephrology, etc).
6. Use Clinical Pharmacology as a model of excellence in Biostatistical Collaboration.
- Point to this model when talking to other departments about the collaboration plan.
- We can also use the model to demonstrate to VUMC leaders that there is an impressive
ROI for money invested in this department.
7. Start a weekly journal club with Clinical Pharmacology.
Action Items, To Do List:
1. Draft an advertisement for the position
2. Offer our short course again and develop part II.
3. Interview Heidi Hamm about needs of Pharmacology.
Background.
Vanderbilt’s Clinical Pharmacology is considered the best in the world. Started in 1963, by Dr. John
Oates, it is a division of the Department of Medicine. Clin Pharm has 33 faculty members (16 tenure
track, 17 research track), 24 fellows. They publish approximately 85 papers per year and bring in $20
million in grant money per year. Dr. Jason Morrow, the new division chief, is enthusiastic about
developing a strong collaboration with Biostatistics and expanding the training program.
The Oates Institute of Experimental Therapeutics is a newly created organization that will be in the
addition above Light Hall and headed by Dr. Dan Roden. The Oates Institute will encompass both the
Division of Clin Pharm and the Department of Pharmacology.
Future Research Opportunities
Dr. Morrow stated that Clin Pharm has traditionally conducted small studies but sees opportunities in the
data mining of large databases. He was impressed by the work that Wayne Ray had done and felt that
with biostatistical collaboration there were exciting opportunities in these observational studies of large
databases. In particular, predicting adverse response to drugs will be an important area of future research.
Several faculty members mentioned the importance of statistical skills to support genetic analysis.
Although, the Program in Human Genetics provides statistical support, investigators have had grants
criticized for the MDR method. In the future, the analysis will be more difficult to understand the
complex genetic contributions. There is a need to help investigators design stronger studies, with
comprehensive databases, better phenotyping, and techniques to minimize the noise.
Investigate prescription pill boxes with chips to track compliance.
Twin registry.
Recruiting
In recruiting new biostatisticians for Clin Phar, Dr. Morrow mentioned that he would like to get someone
who is “user friendly” and has sufficient experience; someone similar to Yu Shyr and Dan Byrne.
The following skills will be needed by biostatisticians recruited for this group:
- Strong in both traditional biostatistics and genetic analysis
- Fluent in stopping rules and DSMB workings.
- Experienced with PK analysis.
Dr. Stein recommended advertising for biostatisticians in journals such as Clinical Pharmacology and
Therapeutics. He also expressed interest in adding a commentary on biostatistics to his journal.
Training
Clin Pharm Grand Rounds are every Tuesday at 8:30 in Light Hall. We can encourage more
biostatisticians to attend.
We can do a better job of advertising Biostatistics Seminars, Workshops, and Clinics.
Lou Shiner’s paper on Discovery vs. confirmation may provide a model for collaboration and partnership
between Clin Pharm and Biostatistics.
Look into a joint division of biostatistics-clin pharm to develop statistical software for clin pharm.