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  4. FDA PUBLIC WORKSHOP: 6th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop - 07/21/2021 - 07/23/2021
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Virtual

Event Title
FDA PUBLIC WORKSHOP: 6th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
July 21 - 23, 2021

Characterizing Physical Function


Date:
July 21 - 23, 2021
Day1:
- ET
Day2:
- ET
Organized By:


Dates:

Day 1: Wednesday, July 21, 2021 Time: 1:00 PM - 4:00 PM ET

Day 2: Friday, July 23, 2021  Time: 9:00 AM - 12:00 PM ET

Twitter: #OCEOutcomes21

Background

The U.S. Food and Drug Administration (FDA) Oncology Center of Excellence (OCE) Patient-Focused Drug Development (PFDD) team welcomes you to the Clinical Outcome Assessments in Cancer Clinical Trials (COA-CCT) sixth annual workshop.

The overarching aim of this year’s workshop remains the same as in past years - to provide a forum for collaborative and productive multidisciplinary discussions to advance the understanding of the complex regulatory, health care policy, and scientific issues surrounding the use of patient-reported outcome (PRO) measures in cancer clinical trials. The workshop will be open to the public, fully virtual, and divided into two half-days. During the four sessions of this workshop, we will focus our discussion on regulatory-grade patient-generated data on physical function (defined as the ability to carry out day-to-day activities that require physical effort) in cancer clinical trials.

On the first day of the workshop (Wednesday, July 21, 2021; 1pm – 4pm ET), we will begin by discussing the importance of measuring physical function in cancer trials, along with trial design considerations to detect changes in this concept. Specifically, we will highlight how to align physical function research questions and trial endpoints with the estimand framework. Next, we will focus on how existing PRO measures of physical function can be further leveraged in cancer clinical trials. We will discuss the relevance of physical function concepts from the patient and clinician perspective, review current available instruments measuring this concept, and highlight those which are considered to be well-defined.

On the second day of the workshop (Friday, July 23, 2021; 9am – 12pm ET), we will discuss analytic considerations of patient-reported physical function data. Various analyses and graphical presentations of hypothetical example physical function data will be shared and the strengths and limitations of different approaches will be discussed, including potential consideration for including physical function data into FDA OCE’s pilot Project Patient Voice. Finally, given the ongoing technical advances in the field, we will close the workshop with a forward thinking session on the future of patient-generated physical function data collection. Novel methods of obtaining this data (e.g., via electronic and wearable devices, sensors, etc.) will be explored, including potential uses within future cancer clinical trials.

The FDA OCE PFDD moderators will be joined by extremely knowledgeable and diverse panelists, and we look forward to productive discussions during this workshop.

Meeting Goals

  • Provide a forum for open discussion between academia, industry, international regulatory, and patient advocacy groups to advance measurement of the patient experience as it relates to physical function in cancer clinical trials;
  • Engage key stakeholders to identify opportunities to overcome barriers to incorporating physical function PROs and discuss actionable next steps;
  • Discuss current FDA approaches to the analysis and review of PRO data specific to physical function;
  • Consider ways in which patient-reported physical function data can be included in FDA OCE’s pilot Project Patient Voice | FDA; and  
  • Envision methods and uses or patient-reported physical function data in the future.

Workshop Materials

  • Agenda
  • Biographies
  • Session 1: Physical Function - Defining the Appropriate Research Question
  • Session 2: Leveraging Existing Measures to Assess Patient-Reported Physical Function
  • Session 3: Analytic Considerations when Measuring Physical Function
  • Session 4: Envisioning Physical Function Moving Forward

Contacts

Joan Ferlo Todd, RN, MS
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.796.6079
Joan.Todd@fda.hhs.gov

Caitlin Drew, MSN, RN
Senior Regulatory Health Project Manager
Oncology Center of Excellence, (OCE)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
10903 New Hampshire Ave, Silver Spring, MD 20993
Tel: 301.318.8609
Caitlin.Drew@fda.hhs.gov

 


Event Materials

Title File Type/Size
COA-CCT 2021 Agenda pdf (142.85 KB)
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