Home
About HMGF
Prospective Students
Current Students
HMGF Program
PhD Programs
HMGF Mentors
UAB Centers
HHMI
SRI
Contact Us
Site Map
Search


peir.net


Logistic and Regulatory Issues in Clinical and Translational Science Mail Email this article  
 Print Printer friendly page  


Course Directors: Richard Kaslow, M.D., M.P.H., and Edward Hook, M.D.

Graduate students in the biomedical sciences receive excellent training in basic science but often have minimal exposure to clinical research. Yet, many find themselves conducting research that requires the ability to assess clinical research data to guide the direction and emphasis of their future research. To remedy this, HMG fellows become familiar with the principles and methods of clinical research and learn how to critically evaluate medical research literature and understand how clinical questions are framed, how studies are designed, and how knowledge is transferred to the bedside.

Course Description:

Students (3 per group) attend two meetings of the UAB Comprehensive Cancer Center's Clinical Trials Review Committee (CTRC).

The CTRC comprises 36 members representing all oncology specialists, bone marrow transplantation, surgical nurses, basic scientists, statisticians, and radiologists. The CTRC’s responsibility is to scientifically review, approve or reject protocols and to establish priorities for clinical protocols conducted within the Cancer Center, including NIH- or cooperative group-funded trials.

Prior to the CTRC meeting, students are paired with primary reviewers to serve as ad hoc reviewers for a specific protocol. Students work with the senior clinical or biostatistical reviewers. Recommendation for approval, administrative review (minor concerns), resubmission (major concerns), or disapproval is made along with the assignment of priority scores. Exposure to this process provides an introduction to study design, IRB issues, and data analysis.

Fellows are able to critically evaluate medical literature and understand how clinical questions are framed, how studies are designed, and how knowledge is transferred back to the bedside.



© Copyright by the University of Alabama at Birmingham

Site Last Updated: May 13th, 2009 - 14:34:17

Top of Page