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

Abstract

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.

Completion and Publication Rates of Randomized Controlled Trials in Surgery

“…[1][2][3] Trials may be discontinued earlier than planned for various reasons, including compelling evidence of treatment benefit or harm, futility, slow recruitment, commercial reasons, or the emergence of new evidence from other trials that negates the need for another study. 4,5 When there is no early evidence of harm or irrefutable benefit, trial discontinuation has a significant scientific, ethical, and economic impact. The involvement of steering committees and Data and Safety Monitoring Boards with members independent of the sponsor is of utmost importance when deciding to stop a trial early.…”

Would Tirofiban Have Been Shown Non‐Inferior to Abciximab Had the TENACITY Trial Not Been Terminated for Financial Reasons?

“…The risk–benefit ratio for patients who enroll with the understanding that they will contribute to improved future care is shifted when a trial is terminated for these reasons. Although many consider early termination of a clinical trial for commercial reasons to be generally unacceptable, exceptions certainly exist.…”

A Duty to Participate in Research: Does Social Context Matter?

“…It is certainly acceptable to stop studies prematurely because of efficacy, safety, or feasibility concerns. However, terminating a study for reasons such as apparent lack of commercial viability, marketing changes, or a lack of positive results upsets the risk-benefit balance of the trial because subjects would have been exposed to risks without the prospect of obtaining valuable scientific knowledge (Iltis 2005;Emmanuel et al 2000) .…”