Bouxsein ML et al. – To ensure optimal development and best use of biomarkers to accelerate drug development, continuous dialog among the health professionals, industry and regulators is of paramount importance. Methods
The concept of surrogate endpoints as it has been developed in other fields of medicine was reviewed and if it could be applied in clinical trials of osteoporosis was discussed
Results
A stepwise approach and possible study designs to qualify a biomarker as a surrogate endpoint in osteoporosis was outlined
Existing data for several potential surrogate endpoints were reviewed to assess their success in meeting the proposed criteria
A research agenda needed to advance the development of biomarkers as surrogate endpoints for fracture in osteoporosis trials was suggested
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