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Clinical Outcome Assessments (COAs) in Cancer Clinical Trials

Clinical Outcome Assessments (COAs) in Cancer Clinical Trials

Date:

June 22, 2018

Location:

Food and Drug Administration
White Oak Campus
The Great Room
Building 31, Room B and C
Silver Spring, MD

I. BACKGROUND

The FDA and ASCO have expressed a willingness to leverage their combined strengths for the joint development of the substantive actions of this workshop to identify best practices for the collection and analysis of patient-reported outcome (PRO) data in cancer clinical trials. The co-sponsors intend to engage with leaders in academia, industry, international regulatory and health technology assessment (HTA) bodies, and patient groups. Patient-reported outcome data are commonly integrated into trials, and this workshop will evaluate current practices and identify opportunities to advance strategies that can provide rigorous PRO data suitable to support regulatory, payer, clinician and patient decision making.

Patient-focused drug development efforts are underway across therapeutic areas. Malignant hematology and oncology (cancer) is an active area of drug development where patient-centered measures of symptoms and function can add important data to inform the risks and benefits of cancer therapies. Clinical Outcome Assessments (COA) are trial measures that quantify how a patient feels or functions. Patient-reported outcomes (PRO), one form of COA, is a measurement based on a report that comes directly from the patient about the status of a patient’s health condition without amendment or interpretation of the patient’s response by a clinician or anyone else. Unique issues exist in cancer clinical trials which make collection of patient-reported outcome (PRO) data challenging. The purpose of this workshop is to provide an open public forum for a broad representation of stakeholders to (a) explore measurement tools and trial design features to generate patient-focused data from cancer clinical trials and (b) explore efforts to analyze, present and interpret PRO data obtained from cancer clinical trials.

Goals and Objectives

  • To provide a forum for open discussion between academia, industry, international regulatory, HTA bodies, and patient groups to advance measurement of the patient experience in cancer clinical trials;
  • Seek feedback from stakeholders on current FDA thinking regarding characteristics of PRO measurement tools and trial designs that can be used to support product labeling;
  • Ensure the leading experts in PRO measurement have an opportunity to evaluate international efforts to standardize PRO data analysis from cancer trials;
  • Obtain feedback on current FDA approaches to the analysis and review of PRO data submitted to FDA to support cancer product applications.

Who Should Attend

This workshop is intended for stakeholders interested in advancing COAs in cancer drug development including, but not limited to international academia, industry, regulatory agencies, consulting firms, health-technology assessment groups and patient groups.

Contact

Valerie Vashio – valerie.vashio@fda.hhs.gov