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EthicsCaseStudyForm edit

Title IND Case Study
Long Title IND Case Study
Contributor/Contact M. E. Blair Holbein, PhD, BCAP (Blair.Holbein@UTSouthwestern.edu)
Contributor Details M. E. Blair Holbein, PhD, BCAP
Director, Clinical Investigator Resource Center
UT Southwestern Medical Center
CTSA UT Southwestern
Case Study Provided Justapill is a novel antihypertensive agent that has just been approved for use in mild to moderate hypertension at a dose of 20 mg once daily. This dose produced blood pressure readings of less than 140/90 mm Hg in 80% of normal weight (BMI < 27) subjects in 2 definitive trials.
Justapill has not been studied in obese subjects.
You propose to do a study in obese subjects (BMI > 33), but plan to increase the dose of 60 mg once daily to compensate for the weight difference of the intended subjects.
Data Acquisition, Management, Sharing and Ownership Topics No Data acquisition_management_sharing and ownership Topics
Mentor and Trainee Responsibilities Topics No mentor and trainee responsibilities topics
Publication Practices and Responsible Authorship Topics No publication practices and responsible authorship topics
Peer Review Topics No peer review topics
Collaborative Science Topics No collaborative science topics
Research Misconduct Topics No research misconduct topics
Conflicts of Interest, Law and Policy Topics No conflicts of interest_law_and policy topics
Human Subjects Human subjects research
Citation M. E. Blair Holbein, PhD, BCAP
URL http://www.utsouthwestern.edu/education/medical-school/departments/clinical-sciences/divisions/ethics-health-policy/index.html
RCR Keyword

Other RCR Keywords Blood Pressure; Body Mass Index (BMI); Clinical Trial; Dose; Human Subjects; Hypertension; Investigational New Drug (IND); Normal Weight; Obese Subjects
Type of Case

Source for Topic Areas Du Bois, J., & Dueker, J. (2009). Teaching and Assessing the Responsible Conduct of Research: A Delphi Consensus Panel Report. Journal of Research Administration, 40(1), 49-70.
References

Other

Topic revision: r2 - 28 Oct 2011 - 13:26:55 - MaryBanach
 
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