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 Highlights ACS CAN's Involvement in the FDA's Patient-Focused Drug Development Initiative

The latest version of FDA's patient-focused drug development initiative is trying to gather patient perspectives in a systematic way, but the effort faces the challenge of understanding the spectrum of those perspectives, said Mark Fleury, PhD, MS, principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network (ACS CAN).


The latest version of FDA's patient-focused drug development initiative is trying to gather patient perspectives in a systematic way, but the effort faces the challenge of understanding the spectrum of those perspectives, said Mark Fleury, PhD, MS, principal of Policy Development and Emerging Science at the American Cancer Society Cancer Action Network (ACS CAN).

Transcript

How is the American Cancer Society Cancer Action Network partnering with FDA’s patient-focused drug development initiative?

ACS CAN is quite interested in the patient-focused drug development, this is an initiative that has evolved over the years with FDA. It started in 2012 with PDUFA [Prescription Drug User Fee Act] V and in that agreement, there was an agreement for FDA to hold 20 different disease-specific meetings. And, basically what they did was, they invited individuals or caregivers with a specific disease to come in and share their experiences with the disease with FDA.

Traditionally, what we’ve had, is we’ve had an individual patient talk to FDA about their individual experience. And, obviously, one person’s experience can’t be extrapolated to everyone, so these meetings were an attempt to get a broader spectrum of viewpoints. But, what the patient community and FDA quickly learned is that you’re still only able to gather the input of the people who can make it to the meeting. FDA tried to facilitate remote attendance and things like that, but we think of this as patient-focused drug development as 1.0.

Version 2.0, which we are moving into as a result of the 21st Century Cures [Act] and the latest PDUFA VI agreement is FDA is required to come up with a series of guidances that inform how we can incorporate the patient perspective but to also gather in a very systematic way so it’s not anecdotal, it’s not a handful of people providing their experience of a disease, but really gathering data in a way that we can be scientifically comfortable that we really captured the full spectrum of patient participation.

So, ACS CAN will be very involved in those meetings and helping to develop those guidance and making sure that they really are patient focused.

What could be the biggest challenges that the initiative faces in the real world?

Well the goal of patient-focused drug development is really to formally insert the patient perspective into the regulatory decision-making process. So, FDA is charged with making a benefit–risk assessment of any drug or device, and really the balance of that benefit and risk is dependent on each individual patient and each individual disease. So, cancer patients, for example, may be willing to take a much greater risk for the opportunity of a benefit than, say, maybe somebody with diabetes would. And, to try to quantify how the patient perspective from disease to disease is going to be really challenging because you have a spectrum of patients—one individual has a different risk–benefit tolerance than another.

So, really, the challenge for this is to sort of create that standardized patient perspective and to be able to capture both what is the average and what is the spectrum of those perspectives.

 
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