Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility Commentary: Early discontinuation violates Helsinki principles

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# Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility {#article-title-2} Editorial by Evans and Pocock 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 Although two trials have shown the efficacy of statins for primary prevention of cardiovascular disease in middle aged people with hypercholesterolaemia, 1 2 the benefits and costs of such treatments in older men and women are unclear, especially in low cardiovascular risk populations.3-5 In April 1997, a group of French academics submitted to several pharmaceutical companies the protocol of the first placebo controlled trial of a statin for primary prevention in hypercholesterolaemic men and women aged 70 to 85 in low cardiovascular risk countries. Novartis agreed to fund the study in June 1998, when the company executives were convinced that this study was …