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The Changing Landscape of Product Development and Randomized Trials
Dirk Stengel, MD, PhD, MSc1
1 Center for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin Trauma Center, Warener Straße7, 12683 Berlin, Germany. E-mail address: dirk.stengel@ukb.de
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Disclosure: The author received payments or services, either directly or indirectly (i.e., via his institution), from a third party in support of an aspect of this work. In addition, the author, or his institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. The author has not had any other relationships, nor has he engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article.

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Investigation performed at the Center for Clinical Research, Department of Trauma and Orthopaedic Surgery, Unfallkrankenhaus Berlin Trauma Center, Berlin, Germany


Copyright © 2012 by The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2012 Jul 18;94(Suppl 1(E)):85-91. doi: 10.2106/JBJS.L.00248
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Abstract

Abstract: 

Controversy exists about whether or not similar standards apply to the clinical evaluation of orthopaedic implants and pharmaceuticals. The long-lasting dispute is likely to be abandoned shortly, given that certain regulatory bodies in Europe now mandate proof of effectiveness by randomized controlled trials (RCTs) prior to market approval of innovative devices. This is a timely signal—it will help to strengthen both the credibility of orthopaedic researchers among all health-care disciplines and the role of manufacturers as creative minds and scientific partners. Yet, it must be accompanied by substantial changes in the current trial landscape.

Given the level of perfection of available orthopaedic technology, superiority of a new product over an established standard will become a rare finding. Noninferiority or equivalence must be accepted as important trial results by investigators, sponsors, clinicians, and health authorities to enhance the spectrum of therapeutic options and help to individualize patient care.

Specific problems are slow recruitment rates and long intervals from the protocol stage to publication of results. This may counteract the innovative potential of a novel product. Pragmatic trial designs, lean but complete documentation, limited but precise end points, the avoidance of competing trials, and the fostering of international collaboration are possible ways to streamline clinical trials of orthopaedic devices. Finally, RCTs should be conducted, conditional to the presumed level of innovation of a new implant, and supplemented by data from registries to fully determine the utility, value, and safety of the intervention.

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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