Clinical Trial Risk in Non-Hodgkin’s Lymphoma: Endpoint and Target Selection

Authors

  • Jayson Lee Parker University of Toronto
  • Zoe Yi Zhang
  • Rena Buckstein

DOI:

https://doi.org/10.18433/J39P45

Abstract

Purpose. To quantify the clinical trial risk of new drug development in Non-Hodgkin’s lymphoma (NHL). Risk estimates for this disease have not been reported before. Methods. We undertook a retrospective review of clinical trials in (NHL) in four subtypes to compare the success rate with the industry average. Our inclusion criteria required that a drug must initiate its phase I trial in one of the four NHL subtypes between 1998 and June 2008 in the US. In addition, clinical trials of new drug candidates that pertain to four subtypes of NHL were retrieved from clinicaltrial.gov. Drug candidates that did not meet these criteria were excluded from the study. Results. The overall success rate (8-11%) was significantly lower than the industry standard (17%). Overall survival (OS) as a secondary outcome appeared more predictive than primary endpoints that were surrogate, of overall success. Further, targeted therapies appear more successful in these lymphoma sub-types than broad acting drugs. Conclusion. Clinical trial risk in NHL, with an 89% failure rate reported here, may be reduced by basing decisions on OS secondary endpoints and biologic drugs. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

Downloads

Download data is not yet available.

Author Biography

Jayson Lee Parker, University of Toronto

Lecturer, Master of Biotechnology Program, Department of Biology and the Institute for Biomaterials and Biomedical Engineering, University of Toronto

Downloads

Published

2011-06-14

How to Cite

Parker, J. L., Zhang, Z. Y., & Buckstein, R. (2011). Clinical Trial Risk in Non-Hodgkin’s Lymphoma: Endpoint and Target Selection. Journal of Pharmacy & Pharmaceutical Sciences, 14(2), 227–235. https://doi.org/10.18433/J39P45

Issue

Section

Pharmaceutical Sciences; Review Articles