The Journal of Bone and Joint Surgery (American) 83:S159-159 (2001)
© 2001 The Journal of Bone and Joint Surgery, Inc.
Selection of a Control Group n BMP Clinical Studies
Gerard Riedel, PhD and
Alexandre Valentin-Opran, MD
Genetics Institute, Inc., 87 Cambridge Park Drive, Cambridge, MA
02140
In support of their research or preparation of this manuscript, one
or more of the authors received grants or outside funding from Genetics
Institute, Inc. In addition, one or more of the authors received
payments or other benefits or a commitment or agreement to provide
such benefits from a commercial entity (Genetics Institute, Inc.). No
commercial entity paid or directed, or agreed to pay or direct,
any benefits to any research fund, foundation, educational institution,
or other charitable or nonprofit organization with which the authors
are affiliated or associated.
| The first 150 words of the full text of this article appear below. |
The design of a bone morphogenetic protein (BMP) clinical study
directly depends on the relationship of the proposed BMP treatment
to the standard of care. One must consider whether the intended
use of BMP will (a) replace or (b) augment the existing surgical
standard of care.
In (a), meaningful clinical studies can be designed to test whether
the proposed BMP treatment is equivalent or superior to the standard
of care. For example, recombinant human (rh) BMP-2 is being tested
as a complete replacement for the use of autograft in several spine
fusion procedures. These clinical studies compare the outcomes of patients
who have been randomized to receive rhBMP-2 or autograft. All patients
receive the same spine instrumentation. The control group (autograft)
was chosen because it represents the current standard of care. The most
conservative design for studies of this sort is one that will definitively
establish the statistical equivalence of . . . [Full Text of this Article]
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