The Conflict Between Randomized Clinical Trials and the Therapeutic Obligation

Abstract

The central dilemma concerning randomized clinical trials (RCTs) arises out of some simple facts about causal methodology (RCTs are the best way to generate the reliable causal knowledge necessary for optimally-informed action) and a prima facie plausible principle concerning how physicians should treat their patients (always do what it is most reasonable to believe will be best for the patient). A number of arguments related to this in the literature are considered. Attempts to avoid the dilemma fail. Appeals to informed consent and mechanisms for minimizing the resulting harm are important for policy, but informed consent is problematic and mechanisms for minimization of harm do not address the dilemma. Appeals to some sort of contract model of justification are promising and illuminating.

The therapeutic misconception and our models of competency and informed consent

“…They are usually necessary if the CT is to generate valid results. Nor is this meant to suggest that these compromises with the ''best'' treatment are done casually or that clinical trials researchers are not concerned to care for their subjects as best as possible given the requirements of the designs of the trials (see, e.g., Zelen, 1979;Kopelman, 1983;Gifford, 1986;Freedman, 1987;Makuch and Johnson, 1989;Volavka, Cooper, Laska, & Meisner, 1996). Indeed, the opposite is often true.…”

OARSI Clinical Trials Recommendations: Design and conduct of clinical trials of surgical interventions for osteoarthritis

“…This is especially important for research team members engaged in enrolling patients. If the enrolling investigator believes that one of the treatments under study is superior, he or she may subtly steer eligible patients away from enrollment in the trial and toward that treatment 4,5 . There is no straightforward way to estimate and remedy biases in enrollment that may arise because investigators lack equipoise 6,7 .…”

Innovative Therapies, Suspended Trials, and the Economics of Clinical Research

“…Any innovative therapy could yield an unexpected harmful or beneficial outcome not envisioned in any previous conceptualization of outcomes. Much of the practitioner-oriented literature notes the possibility of harmful consequences of clinical trials and suggests a balancing of benefit and harm (Levine 1988;Novack et al 1989;Gifford 1986;Hill and Sancho-Garnier 1978). 23 Such an awareness could foster an attitude of caution in the clinical research process.…”