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Project SignifiCanT: Statistics in Cancer Trials

Promoting collaboration in design and analysis of cancer clinical trials

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Project Significant

Project SignifiCanT (Statistics in Cancer Trials) established by the FDA Oncology Center of Excellence, promotes collaboration and engagement among diverse stake holders to further the design and analysis of cancer clinical trials with the goal to advance cancer therapies.

Project SignifiCanT objectives:

  • Provides a platform to participate, discuss, and advance the science of oncology trial designs.
  • Promotes non-product specific scientific discussions on design and analysis of cancer clinical trials.
  • Fosters collaboration among regulators (US and international), professional organizations, industry, academicians, and patients to advance cancer therapies with improved design of cancer clinical trials.

In October 2020, Project SignifiCanT began a collaboration with the Biopharmaceutical Section (BIOP) of American Statistical Association (ASA) to hold scientific discussions with diverse stakeholders who understand the unique aspects of oncology clinical trials. These discussion forums, held approximately once a month, inform and educate on the design and analysis of future oncology clinical trials. These virtual forums are organized jointly by the ASA BIOP Statistical Methods in Oncology Scientific Working Group, the LUNGevity Foundation, and the FDA Oncology Center of Excellence, and hosted by ASA.

Project SignifiCanT collaborates not only among academia and industry but among international regulators. This informal academic collaboration paves a path for cancer patients to receive earlier access to products through more efficient clinical trial designs, conduct, and analyses. Pivotal clinical trials in oncology are commonly conducted internationally and these global trials are important for investigating the safety and effectiveness of cancer therapies. Future cancer therapy developments can be speeded by understanding the complex issues in conducting cancer trials and bringing common understanding among all the stakeholders involved in the development of cancer therapies through improved clinical trial designs.

The Team

  • Rajeshwari Sridhara, PhD, Oncology Center for Excellence
  • Richard Pazdur, Director, OCE
  • Marc Theoret, Deputy Director, OCE

Project Management: Joan Ferlo Todd, RN, Senior Regulatory Health Scientist, OCE

2024 Forums

  • Feb 13, 2024. Interpretation of Results from Hierarchical Testing of Multiple Endpoints, Subgroups, Analyses Across Disease Settings in Cancer Clinical Trials. Publication pending
  • Apr 23, 2024. Statistical Design Considerations in Estimating Contribution of Each Sequential Treatment Effect to the Overall Effect of a Sequence of Treatments in Randomized Cancer Clinical Trials. Publication pending
  • Jun 11, 2024. Trial Considerations in Indolent Cancers with Overall Survival as a Safety Endpoint. Publication pending
  • Jul 16, 2024. Statistical Considerations in the Design of Randomized Pragmatic Cancer Trials. Publication pending
  • Sep 10, 2024. Tolerability Endpoint Considerations to Guide Dosage Optimization in Oncology Clinical Trials. Publication pending.

2023 Forums

2022 Forums 

2021 Forums

2020 Forums

For Further Information

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