Commentary The clinically - integrated randomized trial : proposed novel method for conducting large trials at low cost

Introduction: Randomized controlled trials provide the best method of determining which of two comparable treatments is preferable. Unfortunately, contemporary randomized trials have become increasingly expensive, complex and burdened by regulation, so much so that many trials are of doubtful feasibility. Discussion: Here we present a proposal for a novel, streamlined approach to randomized trials: the "clinically-integrated randomized trial". The key aspect of our methodology is that the clinical experience of the patient and doctor is virtually indistinguishable whether or not the patient is randomized, primarily because outcome data are obtained from routine clinical data, or from short, web-based questionnaires. Integration of a randomized trial into routine clinical practice also implies that there should be an attempt to randomize every patient, a corollary of which is that eligibility criteria are minimized. The similar clinical experience of patients onand off-study also entails that the marginal cost of putting an additional patient on trial is negligible. We propose examples of how the clinically-integrated randomized trial might be applied in four distinct areas of medicine: comparisons of surgical techniques, "me too" drugs, rare diseases and lifestyle interventions. Barriers to implementing clinically-integrated randomized trials are discussed. Conclusion: The proposed clinically-integrated randomized trial may allow us to enlarge dramatically the number of clinical questions that can be addressed by randomization. Introduction Consider that participation in a typical randomized trial is a quite distinct from usual clinical care. From the patients' point of view, participation in a trial generally requires additional tests, clinic visits and procedures such as scans and biopsies, as well as a large number of questionnaires. For the doctor, having a patient on trial involves a considerable amount of additional paperwork, everything from documenting eligibility, recording the results of protocol specific tests and fulfilling regulatory requirements: a patient on chemotherapy who had a moderately abnormal white count would be followed carefully; if the the same patient was on a chemotherapy trial, the abnormal white count would likely necessitate several letters to various oversight bodies describing the adverse event, the causal relationship to the investigational agent and the resulting medical treatment. Participation in a randomized trial is also made distinct by its rarity: a review of randomized trials in surgery, for example, estimated that typically fewer than 1% of eligible patients are accrued[1]. Indeed, there is a considerable literature on the difficulties of accruing patients to clinical trials[2,3]. Published: 5 March 2009 Trials 2009, 10:14 doi:10.1186/1745-6215-10-14 Received: 23 July 2008 Accepted: 5 March 2009 This article is available from: http://www.trialsjournal.com/content/10/1/14 © 2009 Vickers and Scardino; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.