Abstract
Studies that evaluate the efficacy of cardiovascular drugs vary greatly in their protocol design and choice of therapeutic endpoints. Yet, not all protocol designs can provide compelling evidence for the utility of a new drug; some designs are sufficiently flawed to make an interpretable outcome unlikely. Similarly, not all endpoints provide similarly strong evidence of efficacy. A clear distinction should always be made between endpoints that establish the activity and those than establish the efficacy of a new drug, particularly when a surrogate endpoint is used as the primary measure of the utility of an experimental agent.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
Packer M. J Am Coll Cardiol 9:433–438, 1987.
McKay CR, Nana M, Kawanishi DT, et al. Circulation 72: 865–872, 1985.
Parodi O, Simonetti I, L’Abbate A, Maseri A. Am J Cardiol 50: 923–928, 1986.
Cohn JN, Frarciosa JA, Francis GS, et al. N Engl J Med 306: 1129–1135, 1982.
Packer M, Medina N, Yushak M. Circulation 71: 761–766, 1985.
Packer M, Melier J, Medina N, Yushak M, Gorlin R. Circulation 64: 506–514, 1981.
Mueller HS, Chohine RA. Am J Med 71:645–657, 1981.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1989 Kluwer Academic Publishers
About this chapter
Cite this chapter
Packer, M. (1989). Pitfalls in the Design and Evaluation of Clinical Trials of Intravenously Administered Cardiovascular Drugs. In: Morganroth, J., Moore, E.N. (eds) Risk/Benefit Analysis for the Use and Approval of Thrombolytic, Antiarrhythmic, and Hypolipidemic Agents. Developments in Cardiovascular Medicine, vol 100. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-1605-3_2
Download citation
DOI: https://doi.org/10.1007/978-1-4613-1605-3_2
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4612-8888-6
Online ISBN: 978-1-4613-1605-3
eBook Packages: Springer Book Archive