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  1. Oncology Center of Excellence

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. The topic for the first meeting was, “Type I error considerations in Master Protocols with common control in oncology clinical trials.” Additional discussions, approximately once a month, may inform and enlighten the design and analysis of future oncology clinical trials. These virtual discussions are organized jointly by the ASA BIOP Statistical Methods in Oncology Scientific Working Group, the FDA Oncology Center of Excellence, and LUNGevity Foundation, and hosted by ASA.

Project Significant collaborates not only among academia and industry but among international regulators. This informal academic collaboration can pave 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

Publications

  1. Sridhara R, Marchenko O, Jiang Q, et.al. Use of Non-concurrent Common Control for Treatment Comparisons in Master Protocols. Biopharmaceutical Report, 2021, Vol. 28, No. 1, 12-14.
  2. Barksdale E, Sridhara R, Marchenko O, et al. Summary of American Statistical Association Biopharmaceutical Section’s Virtual Discussions with Regulators on Statistical Considerations in Oncology Trials in the COVID-19 Era. Biopharmaceutical Report, 2021, Vol. 28, No. 3, pp 23-25.
  3. Marchenko O, Sridhara R, Jiang Q, et.al. Summary of ASA Virtual Discussion with Regulators on Designing Dose-Optimization Studies in Cancer Drug Development. Biopharmaceutical Report, 2021, Vol. 28, No. 3, 26-27.
  4. Sridhara R, Marchenko O, Jiang Q, et.al. Summary of American Statistical Association Biopharmaceutical Section’s Virtual Discussions with Regulators on Evaluation of Treatment Effect in Underrepresented Population in Oncology Clinical Trials. Biopharmaceutical Report, 2021, Vol. 28, No. 3, pp 28-30.
  5. Sridhara R, Marchenko O, Jiang Q, et al. Type I Error Considerations in Master Protocols With Common Control in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion. Statistics in Biopharmaceutical Research, 2022, Vol. 14 No. 3, 348-352. 
  6. Sridhara R, Marchenko O, Jiang Q, et.al. Use of Nonconcurrent Common Control in Master Protocols in Oncology Trials: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion. Statistics in Biopharmaceutical Research, 2022, Vol. 14 No. 3, 353-357. 
  7. Sridhara R, Marchenko O, Jiang Q, et.al. Summary of ASA Virtual Discussion with Regulators on Statistical Considerations in Clinical Trials for Rare Pediatric Cancers. Biopharmaceutical Report, 2022, Vol. 29, No 1, 30-32.
  8. Sridhara R, Marchenko O, Jiang Q, et. al. Summary of American Statistical Association Biopharmaceutical Section’s Virtual Discussion with Regulators on Time-to Event Endpoints in Cancer Trials in the Presence of Non-proportional Hazards, Biopharmaceutical Report, 2022, Vol. 29, No. 2, 42-44.
  9. Sridhara R, Marchenko O, Jang Q, et. al. Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Consideration of Bayesian Approaches in Pediatric Cancer Clinical Trials. Biopharmaceutical Report, 2022, Vol. 29, No. 3, 45-46.
  10. Sridhara R, Marchenko O, Jang Q, et. al. Summary of ASA BIOP Section’s Virtual Discussion with Regulators on Considerations for Data Monitoring Committee and Regulator Direct Interactions in Ongoing Randomized Cancer Clinical Trials. Biopharmaceutical Report, 2022, Vol. 29, No. 3, 47-49. 
  11. Sridhara R, Barksdale E, Marchenko O, et al. Cancer Clinical Trials Beyond Pandemic: Report of an American Statistical Association Biopharmaceutical Section Open Forum Discussion. Statistics in Biopharmaceutical Research, 2023, Vol. 15 No. 2, 4444-449. 
  12. Sridhara R, Marchenko O, Jang Q, et al. Letter to Editor. Evaluation of Treatment Effect in Underrepresented Populations in Cancer Trials: Discussion with International Regulators. Statistics in Biopharmaceutical Research, 2023, Vol. 15 No. 2, 450-456.
  13. Marchenko O, Sridhara R, Jang Q, et. al. Letter to Editor. Designing Dose-Optimization Studies in Cancer Drug Development: Discussions with Regulators. Statistics in Biopharmaceutical Research, 2023, Feb 14 online pp 1-7. 

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