Early stopping of trials

Hopf, G

doi:10.1016/s0140-6736(05)62079-x

Cited by 5 publications

(3 citation statements)

References 2 publications

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“…The early closure of the European pimagedine trial by its pharmaceutical company sponsors for financial reasons was announced in a letter to the Lancet in 1997 6. An editorial denounced “a curious stopping rule from Hoechst Marion Roussel.”7 The publicity led to two other cases being brought to the attention of readers: a prospective study of reinfarction after treatment with Cardizem was discontinued after 500 patients had been included out of 7000 planned,8 and a study of liposomal doxorubicin in metastatic breast cancer was also stopped early 9. In both the pimagedine and the fluvastatin trial the study committees and investigators were notified of the sponsor's decision afterwards.…”

Section: Previous Examples Of Early Discontinuation For Economic Reasonsmentioning

confidence: 99%

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

Lièvre¹,

Ménard²,

Bruckert³

et al. 2001

BMJ

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Section: Previous Examples Of Early Discontinuation For Economic Reasonsmentioning

confidence: 99%

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

Lièvre¹,

Ménard²,

Bruckert³

et al. 2001

BMJ

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“…Many clinical trials are terminated early due to safety and/or efficacy concerns, and less often due to unexpected “positive” findings [[1], [2], [3]]. However, early termination of post-approval (Phase IV) pragmatic randomized trial, for commercial reasons [[4], [5], [6], [7], [8], [9], [10]] is less frequent, may be more complex, and may require added flexibility in closure methods, including short term follow-up [8,11].…”

Section: Introductionmentioning

confidence: 99%

Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience

Kolitsopoulos

Gatto

Sweetland

et al. 2019

Contemporary Clinical Trials Communications

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IntroductionMany clinical trials terminate early due to safety and efficacy concerns, and less often due to unexpected “positive” findings. However, early termination of post-approval (Phase IV) pragmatic randomized trials for commercial reasons is less frequent, may be more complex, and may require added flexibility in closure methods, including short term follow-up. VOLUME was a randomized, open-label, post-approval pragmatic clinical trial (PCT) or large simple trial that terminated early due to product withdrawal. The aim of this paper is to describe circumstances unique to post-approval PCTs that may require a closure amendment rather than immediate study termination, and our recommendations for operational study closure in these circumstances. We use the VOLUME case study throughout to provide a practical example.MethodsStudy closeout considerations at the study level include: notifying external governance bodies, e.g., data monitoring committees (DMC), and scientific steering committees (SSC); executing a study closure amendment; notifying and training of study physicians; and institutional review board (IRB)/ethics committee (EC) approvals. Study closure considerations at the patient level focus on patient safety and include: patient notification, efficient transition to alternative treatments, the need for re-consenting; and drug supply shortages.ConclusionsEarly study closeout logistics require careful analysis, detailed planning, and close coordination, and are ideally considered at the study planning phase. Lessons learned from the VOLUME closeout should help other researchers devise contingencies when terminating post approval pragmatic trials that utilize a marketed product.ClinicalTrials.gov: NCT00359801.

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“…[1][2][3][4] Sponsors do not usually disclose the precise nature of their decisions; they assert only that trials are stopped for commercial reasons (rather than for safety or efficacy concerns). Because the results of a study terminated early are not normally published (see Black et al 3 for an exception), it is difficult to obtain substantial information regarding the nature of the study, the conditions under which it was terminated, the number of participants enrolled, the benefits that were anticipated, and the number of other studies that have been terminated early for commercial reasons.…”

mentioning

confidence: 99%

Stopping trials early for commercial reasons: the risk–benefit relationship as a moral compass: Table 1

Iltis

2005

J Med Ethics

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Decisions by industry sponsors to end clinical trials early for commercial reasons have been the subject of controversy. I argue that the principal consideration in assessing these decisions ought to be the way in which the termination would affect the trial’s risk–benefit relationship. If there is not yet sufficient benefit to be gained from the study to offset the risks to which participants were exposed and it is expected that important scientific information would be obtained if the trial were continued, early termination constitutes an unethical alteration of the risk−benefit relationship. This violates the grounds on which permission is given to conduct human research, patients consent to participate, and investigators agree to conduct studies. These knowable and avoidable changes in risk–benefit relationship shouldgenerallybe seen as impermissible.

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Early stopping of trials

Cited by 5 publications

References 2 publications

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

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

Implications of product withdrawal on a post-approval pragmatic trial: The VOLUME study experience

Stopping trials early for commercial reasons: the risk–benefit relationship as a moral compass: Table 1

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