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Published on: September 18, 2013
Clinical trial risk in Non-Hodgkin's lymphoma: endpoint and target selection
Jayson L Parker1, Zoe Yi Zhang, Rena Buckstein
1Biology Department, Master of Biotechnology Program, University of Toronto, Toronto, ON. jayson.parker@utoronto.ca
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.
Insights
New drug development for Non-Hodgkin's lymphoma (NHL) has an 89% failure rate, significantly lower than the industry average. Focusing on overall survival endpoints and targeted therapies may improve clinical trial success rates in NHL.
Area of Science:
- Oncology
- Clinical Trials
- Drug Development
Background:
- Non-Hodgkin's lymphoma (NHL) encompasses various subtypes, each with unique clinical and pathological characteristics.
- Assessing the risk and success rates of clinical trials is crucial for optimizing drug development strategies in oncology.
Purpose of the Study:
- To quantify the clinical trial failure rate for new drug development specifically within Non-Hodgkin's lymphoma (NHL).
- To establish baseline risk estimates for NHL drug development, as none were previously reported.
Main Methods:
- A retrospective review of clinical trials for four NHL subtypes initiated between 1998 and 2008 in the US was conducted.
- Data from clinicaltrial.gov were analyzed, comparing NHL trial success rates against industry averages.
- Inclusion criteria focused on new drug candidates entering Phase I trials within the specified timeframe and subtypes.
Main Results:
- The overall success rate for new drugs in NHL clinical trials was 8-11%, significantly lower than the industry standard of 17%.
- Overall survival (OS) emerged as a more reliable predictor of success than surrogate primary endpoints.
- Targeted therapies demonstrated higher success rates compared to broadly acting agents in NHL subtypes.
Conclusions:
- The study reports an 89% failure rate for clinical trials in NHL, highlighting a substantial risk.
- Clinical trial decision-making in NHL could be improved by prioritizing overall survival endpoints.
- The development of biologic and targeted therapies shows promise for increasing success rates in NHL drug development.
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