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  4. FDA WORKSHOP: 8th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop - 06/27/2023
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Virtual | Virtual

Event Title
FDA WORKSHOP: 8th Annual Clinical Outcome Assessment in Cancer Clinical Trials Workshop
June 27, 2023

Overall Side Effect Impact: A Core Oncology Patient-Reported Outcome

Date:
June 27, 2023
Time:
11:00 AM - 3:00 PM ET

Twitter:#OCEOutcomes23

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 Assessment in Cancer Clinical Trials (COA-CCT) 8th annual workshop.

Each year, the COA-CCT workshop provides 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.

In the FDA Draft Guidance on Core Patient-Reported Outcomes in Cancer Clinical Trials, FDA recommends collecting and analyzing the following core PROs: disease-related symptoms, symptomatic adverse events, overall side effect impact summary measure, and physical and role function.  Many of these core PROs have been discussed in detail during past COA-CCT workshops. 

For this year’s workshop, we will focus our discussion on overall side effect impact as a PRO measure in cancer clinical trials. Patient experiences of treatment-related side effects may vary greatly within and between individual patients. For example, patients may experience side effects differently based on frequency, severity, and duration, and depending upon what each individual patient considers to be tolerable.  An overall side effect impact measure provides a way to characterize the totality of side effects experienced by patients, as a complement to symptom specific PRO items. Including a PRO measure for overall side effect impact in cancer clinical trials provides additional information about tolerability from the patient perspective that may not otherwise be captured, throughout oncology therapy development.  

The workshop will include three sessions and will be fully virtual and open to the public. Meeting registration is required using the link provided above.

Meeting Goals

  • Provide a forum for open discussion between regulators, academia, international experts, and patient advocates to advance measurement of the patient experience related to overall side effect impact in cancer clinical trials
  • Engage key stakeholders to identify opportunities to incorporating measurement of overall side effect impact as a PRO measure in cancer trials and discuss actionable next steps
  • Discuss current approaches to the analysis of longitudinal patient-reported overall side effect impact and how these data could be considered for regulatory purposes
  • Consider ways in which overall side effect impact data can be communicated, including in FDA OCE’s Project Patient Voice

Workshop Materials

For past COA-CCT workshops, go to the events section FDA OCE Patient-Focused Drug Development Program webpage.

Contacts

Caitlin Drew, MSN, RN
Health Scientist
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

Joan Ferlo Todd, RN
Senior Senior Health Scientist
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

 

 

Event Materials

Title File Type/Size
COA-CCT 2023 Agenda pdf (204.97 KB)
COA-CCT 2023_Bios pdf (566.57 KB)
 
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