Lessons from ECMO

Robert D. Truog, “Randomized Controlled Trials: Lessons from ECMO,” Clinical Research 40 (3), 519-527, 1992.

ECMO trial’s use of randomized consent should be seen as symptom of two deeper ethical concerns about trial design:

1. ECMO was a potentially life-saving therapy. When the experimental therapy is a potentially life-saving therapy, clinical equipoise is insufficient justification for randomizing patients between the experimental therapy and standard care, because patients don’t expect physicians to weigh benefit to society (generalizable knowledge generated by RCT) against personal views about best therapy. Also, informed consent is not a sufficient waiver of the therapeutic obligation, because patients in these situations are extremely vulnerable and desparate.
2. ECMO was a rapidly developing technology. The length of an RCT means that, as the trial progresses, the experimental therapy used within the trial ceases to be state-of-the-art, and the control therapy ceases to be the best standard care. Also, by the end of the trial, the compared therapies may be obsolete.

Truog proposes a prospective observational study as an alternative to RCT, for getting data about the effectiveness of ECMO in pediatric patients.

Tags: consent, trial design