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The Journal of Bone and Joint Surgery 79:1089-98 (1997)
© 1997 The Journal of Bone and Joint Surgery, Inc.

Current Concepts Review

Current Concepts Review - The Conduct of Orthopaedic Clinical Trials*

ROBERT L. FUSON, M.D.{dagger}, MAX SHERMAN, B.S.{ddagger}, JOHN VAN VLEET, B.S., M.T.(ASCP), M.S.§ and THEODORE WENDT, PH.D.¶, WARSAW, INDIANA

*One or more of the authors has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article. In addition, benefits have been or will be directed to a research fund, foundation, educational institution, or other non-profit organization with which one or more of the authors is associated. No funds were received in support of this study.


   Introduction
 
The work of clinical investigators is commonly said to be a search for the truth. Many years ago, Cannon rephrased this objective in less pretentious rhetoric, saying that the investigator tries to learn whether facts that others will recognize as facts can be established and whether the facts will support some projected theory6. Today, we call a projected theory a hypothesis and we call facts clinical data. Civilized countries have established rules governing the attainment of such data, and these rules, or standards, govern the scientific and ethical conduct for clinical trials.

The art of clinical trials has become more refined over the years through the application of recognized scientific principles to the interpretation of results. In addition, today's computer technology, coupled with powerful statistical methods, permits rapid evaluation of complex variables. A clinical trial to determine the safety and efficacy of an orthopaedic device represents a process in . . . [Full Text of this Article]


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