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Health Affairs (Project Hope)|June 18, 2011
Despite criticism of the FDA review process, new cancer drugs reach patients sooner in the United States than in EuropeSamantha A Roberts, Jeff D Allen, Ellen V SigalValue in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research|February 27, 2017
The Value of Addressing Patient PreferencesJeff D Allen, Mark D Stewart, Samantha A Roberts, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|December 12, 2023
An Analysis of Dosing-Related Postmarketing Requirements for Novel Oncology Drugs Approved by the U.S. Food and Drug Administration, 2012-2022Grace Collins, Brittany McKelvey, Hillary S Andrews, et al.Therapeutic Innovation & Regulatory Science|May 15, 2025
Companion Diagnostic FDA Review Flexibilities: An Assessment of CDx for NSCLC to Support Aligned Approaches for ValidationHillary S Andrews, Grace Collins, Bernat Navarro-Serer, et al.Therapeutic Innovation & Regulatory Science|October 27, 2025
Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification ProgramGrace Collins, Jeff D Allen, Hillary S Andrews, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|June 17, 2024
An Evaluation of Novel Oncology Approvals with a PMR/C for Assessing Data in Racial and Ethnic Populations Underrepresented in Premarket Clinical TrialsGrace Collins, Hillary S Andrews, Brittany McKelvey, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|May 14, 2013
Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvalsMichael B Shea, Samantha A Roberts, Jessica C Walrath, et al.Clinical Cancer Research : an Official Journal of the American Association for Cancer Research|May 31, 2013
Developing standards for breakthrough therapy designation in oncologySandra J Horning, Daniel A Haber, Wendy K D Selig, et al.Nature Reviews. Drug Discovery|September 7, 2013
Considerations for the successful co-development of targeted cancer therapies and companion diagnosticsJane Fridlyand, Richard M Simon, Jessica C Walrath, et al.Nature Reviews. Clinical Oncology|July 4, 2012
Reducing the toxicity of cancer therapy: recognizing needs, taking actionCharles S Cleeland, Jeff D Allen, Samantha A Roberts, et al.Pageof 2