Currently Viewing:
Patient-Centered Oncology Care
Currently Reading
Oncologists Can Save Oncology If They Take Ownership of Costs, Kolodziej Says
November 17, 2017
Documenting When a Patient Falls Outside a Recommended Pathway
November 20, 2017
Ian Manners: Addressing Financial Toxicity for Patients
November 29, 2017
The Importance of Teamwork in Oncology Care Transitions
November 30, 2017
Dr Brenton Fargnoli Highlights How Practices Can Prepare for Downside Risk
December 15, 2017
Kathleen Lokay: Clinical Pathways Can Prevent Prior Authorization Delays
December 24, 2017
Torrie Fields: Data Collection Takes the Guesswork Out of Care
January 01, 2018
Kathleen Lokay on How Data Generation Informs Clinical Pathways
January 16, 2018
Dr Brenton Fargnoli Discusses the Creation of a Learning Health System
January 25, 2018
Kathleen Lokay on Educating Patients on Treatment Options
January 28, 2018
Dr Brenton Fargnoli Explains How Quality Measurement Benchmarks Drive Action
February 09, 2018
Jason Harris Discusses the Importance of Real-World Evidence
February 11, 2018
Kathleen Lokay: Implementing Value in Clinical Pathways
February 13, 2018
Dr Brenton Fargnoli on Fixing Issues Physicians Have With EHRs
February 18, 2018
Jason Harris: Improving Patient Understanding and Promoting High-Value Care
March 02, 2018
Dr Thomas Graf on the Impact of New Therapies in Oncology
March 12, 2018
Ian Manners Explains the Impact of Patient Financial Assistance Programs
March 17, 2018
Jason Harris Highlights National Health Council's Recommendations on Real-World Evidence
March 18, 2018
Dr Thomas Graf: How the Impact of Novel Therapies Varies Among Stakeholders
March 22, 2018
Dr Stacey McCullough on the Pharmacist's Role in Patient Education
March 29, 2018
Kathleen Lokay: Incorporating the Latest Research and Supporting Physicians
April 05, 2018
Dr Thomas Graf Discusses the Effect of Novel Therapies on Private Coverage
April 06, 2018
Torrie Fields: Collecting and Using Data Can Better Inform a Patient
April 12, 2018
Dr Stacey McCullough Discusses Teamwork and Collaboration in Oncology
April 13, 2018

Dr Mark Fleury on 21st Century Cures and Cancer Care

The 21st Century Cures Act, in many ways, helps drugs in other disease areas going through review with FDA get to the same standard of the oncology area, said Mark Fleury, PhD, MS, principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network (ACS CAN).


The 21st Century Cures Act, in many ways, helps drugs in other disease areas going through review with FDA get to the same standard of the oncology area, said Mark Fleury, PhD, MS, principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network (ACS CAN).

Transcript

How do you think the provisions within the 21st Century Cures Act would impact cancer care in the United States?

The 21st Century Cures Act really was about trying to ensure FDA used its maximum flexibility and was really forward leaning in terms of how they handled drug development. FDA is a large organization and drug review is done by disease type. The oncology review divisions have traditionally been very forward leaning in terms of accepting novel endpoints, novel trial designs, smaller trials, and using more of the accelerated pathways. So, in many ways, 21st Century Cures, from a messaging standpoint, was telling FDA to sort of behave in that aggressive way across disease types. So, it was really an affirmation of the way the cancer review divisions were already behaving.

But one of the things it also did was formalize the Oncology Center of Excellence, and it was really a recognition that somewhere around 40% of all drugs being developed today are for oncology indications. So, it’s the biggest workload that FDA has, and there’s a recognition that that expertise needs to be shared across different reviews. And, also, the message is that FDA is not there to just simply review applications, but they’re really there to develop and promulgate better regulatory science, to help develop the tools that makes it easier and faster to get drugs to patients.

 
Copyright AJMC 2006-2018 Clinical Care Targeted Communications Group, LLC. All Rights Reserved.
x
Welcome the the new and improved AJMC.com, the premier managed market network. Tell us about yourself so that we can serve you better.
Sign Up