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Selection of a control group in BMP clinical studies.

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 the two treatments. The size of each group should be sufficiently large to allow a conclusion that the outcome of the two treatments differs by no more than a small amount (e.g., ±10%) and should limit the probability of a type II error (not detecting a difference that actually exists) to less than 20%.

In (b), the only meaningful design for a clinical study is one that tests whether the proposed BMP treatment …