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Premature Termination of Clinical Trials
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To the Editor: Drs Psaty and Rennie1 discussed ethical imperatives against premature discontinuation of clinical trials for financial reasons. They argued that this causes harm by breaking the implicit and explicit agreements with research participants, investigators, and the oversight bodies that approved the protocol. Although the authors focused on industry-sponsored trials, their arguments actually apply to all clinical research regardless of sponsorship.
Investigator-initiated studies, for instance, often have less structure and ongoing oversight than do large industry-sponsored clinical trials but the obligations to the participants are no less. Despite this, such projects are often prematurely terminated for a variety of reasons not prespecified in the protocol and contrary to the original study intent and design. In my experience, reasons cited for premature termination of investigator-initiated studies include loss of extramural funding, difficulty in completing the study as originally planned, and the investigator simply thinking that the study has accrued enough . . . [Full Text of this Article]
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