Discontinued Clinical Trial
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A Discontinued Clinical Trial is a clinical trial that started but did not complete.
- Context:
- Some trials are discontinued prematurely by their sponsor for strategic reasons
- It can be discontinued for reasons pertaining to efficacy, safety ,or feasibility
- It can be discontinued for strategic reasons (though deceives the patients, jeopardises the patient-doctor relationship, and harms the medical community).
- …
- Some trials are discontinued prematurely by their sponsor for strategic reasons
- Example(s):
- the one reported in (Lièvre et al., 2001).
- …
- Counter-Example(s):
- See: Discontinued Clinical Trial Participant.
References
2000
- (Lièvre et al., 2001) ⇒ Michel Lièvre, K. Boyd, Joël Ménard, Eric Bruckert, Joël Cogneau, François Delahaye, Philippe Giral et al. (2001). “Premature Discontinuation of Clinical Trial for Reasons Not Related to Efficacy, Safety, Or FeasibilityCommentary: Early Discontinuation Violates Helsinki Principles.” BMJ, 322(7286).
- ABSTRACT: When investigators embark on a clinical trial, they naturally expect that the journey will end with the completion of the scheduled patient follow up and publication of the results. Some trials may sink en route because of organisational or ethical reasons, and such misfortunes must be accepted. Sometimes, however, trials are scuttled by their sponsors. Such premature discontinuation not only is frustrating for investigators but may have important medical implications. In this article we analyse the case of a clinical trial that was recently stopped for financial reasons, discuss the consequences of such discontinuations, and make some proposals to avoid recurrence.
- Summary points
- Some trials are discontinued prematurely by their sponsor for strategic reasons
- Clinical trials should be discontinued only for reasons pertaining to efficacy, safety ,or feasibility
- Premature discontinuation of trials for strategic reasons deceives the patients, jeopardises the patient-doctor relationship, and harms the medical community
- Giving more power to steering committees that are mostly independent of the sponsor and include patient representatives, may limit the risk of premature discontinuation of trials for strategic reasons
- Public financial and scientific participation in some trials and increasing the length of patents may be useful