A New Model: The Clinically Integrated Randomized Trial
Vickers AJ, Scardino PT. The clinically-integrated randomized trial: proposed novel method for conducting large trials at low cost. Trials. 2009 Mar 5;10:14. PMID: 19265515.
Andrew Vickers and Peter Scardino, of Memorial Sloan-Kettering Cancer Center, propose a new method of conducting large clinical trials - the clinically integrated clinical trial.
What is a clinically integrated clinical trial? An extended quote from the discussion gives a general idea:
"We propose to integrate randomized trials and routine clinical practice, a design we term the "clinically-integrated randomized trial". The key principle is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized. Trial patients go through informed consent procedures, and certain aspects of care, such as modifications to the surgical technique used, are determined by randomization rather than being at the discretion of the doctor. Otherwise, there are no obvious differences between the clinical care, follow-up, payment and documentation requirements between patients who do and do not participate in the trial. Integration of a randomized trial into routine clinical practice also implies that randomization itself is routine, in other words, there should be an attempt to randomize every patient. A corollary is that eligibility criteria need to be minimized. The only eligibility criterion should be that the doctor is uncertain about which of the treatments in the trial would be best for the patient, the ‘uncertainty principle.’"
Scardino is a surgical oncologist specializing in prostate cancer, and the article offers a detailed hypothetical example of a clinically integrated clinical trial in surgery for prostate cancer. Briefer examples involve "me-too drugs," rare diseases, and lifestyle interventions.
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