Education And Debate

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

BMJ 2001; 322 doi: https://doi.org/10.1136/bmj.322.7286.603 (Published 10 March 2001) Cite this as: BMJ 2001;322:603

Premature discontinuation of clinical trial for reasons not related to efficacy, safety, or feasibility

  1. Michel Lièvre (ml@upcl.univ-lyon1.fr), associate professora,
  2. Joël Ménard, professorb,
  3. Eric Bruckert, professorc,
  4. Joël Cogneau, general practitionerd,
  5. François Delahaye, professore,
  6. Philippe Giral, registrarc,
  7. Eran Leitersdorf, professorf,
  8. Gérald Luc, director of researchg,
  9. Luis Masana, professorh,
  10. Philippe Moulin, professore,
  11. Philippe Passa, professori,
  12. Denis Pouchain, general practitionerj,
  13. Gérard Siest, professork
  1. a Clinical Pharmacology Unit, Faculté de Médecine Laënnec, BP 8071, 69376 Lyons Cedex 08, France
  2. b Internal Medicine Department, Hôpital Européen Georges Pompidou, 75908 Paris Cedex 15, France
  3. c Endocrinology Department, Hôpital de la Pitié-Salpêtrière, 75651 Paris Cedex 13, France
  4. d General Practice, 371710 Chambray les Tours, France
  5. e Lyons Cardiological Hospital, 69500 Bron, France
  6. f Division of Medicine, Hadassah University Hospital, 91120 Jerusalem, Israel
  7. g Institut National de la Santé et de la Recherche Medicale, U325, 59019 Lille, France
  8. h Department of Internal Medicine, Hospital Universitari de Sant Joan, 42201 Reus, Tarragona, Spain
  9. i Diabetology Unit, Hôpital Saint Louis, 75475 Paris Cedex 10, France
  10. j General Practice, 94300 Vincennes, France
  11. k Drugs Center, Institut National de la Santé et de la Recherche Médicale, U525, 54000 Nancy, France
  12. Institute of Medical Ethics, Geriatric Medicine, Edinburgh University, Edinburgh EH3 9EW
  1. Correspondence to: M Lièvre
  • Accepted 27 October 2000

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

Recent example

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 …

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