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EthicsCaseStudyForm edit

Title DSMB - Continuing an under-powered study
Long Title Data Safety and Monitoring Board - Continuing an under-powered study for compassionate reasons
Contributor/Contact Daniel T. Lackland, DRPH (lackland@musc.edu)
Contributor Details Daniel T. Lackland, DRPH
Department of Neurosciences Institute for Human Values in Health Care
Medical University of South Carolina
19 Hagood Ave.
Charleston, SC 29403
Case Study Provided A sickle cell trial is assessing pain medications for patients. One of the agents is very effective but not readily available to the general patient population.

After 3 years, it is determined that the study is underpowered and results will not yield a significant contribution because of the lack of an adequate sample. In particular, the recruitment and enrollment has not obtained the proposed sample.

According to the analytical proposal, it is time to end the trial, with patients returning to their usual care. At the DSMB reporting from the investigators of the study a passionate plea is made indicating the need for these patients to continue to receive this effective therapy.
Data Acquisition, Management, Sharing and Ownership Topics
Scientific methodology issues including research design_objectivity and bias,
Data reporting
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

URL https://sctr.musc.edu/
RCR Keyword Intellectual Work, Ideas
Other RCR Keywords Analytical Proposal; DSMB Reporting; End the Trial; Investigators; Not Available to General Patient Population; One of the Agents is Effective; Pain Medications; Patients; Patients Returning to Usual Care; Proposed Sample; Recruitment and Enrollment; Results do not Show Significant Contribution; Sickle Cell Trial; Sickle Cell-Pain; Study is Underpowered; These Patients Need to Continue to Receive this Effective Therapy
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.


Topic revision: r2 - 11 Nov 2011 - 10:12:44 - MarkYarborough
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