TY - JOUR
T1 - Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials
AU - King-Kallimanis, Bellinda L.
AU - Cella, David
AU - Calvert, Melanie
AU - Cocks, Kim
AU - Coens, Corneel
AU - Fairclough, Diane
AU - Howie, Lynn
AU - Jonsson, Pall
AU - Mahendraratnam, Nirosha
AU - Maues, Julia
AU - Sarac, Sinan
AU - Sasseville, Maxime
AU - Shaw, Jim
AU - Stigger, Nichelle
AU - Trask, Peter
AU - Wieseler, Beate
PY - 2023/7/6
Y1 - 2023/7/6
N2 - Patient-reported outcome (PRO) data are critical in understanding treatments from the patient perspective in cancer clinical trials. The potential benefits and methodological approaches to the collection of PRO data following treatment discontinuation (e.g., due to progressive disease or unacceptable drug toxicity) are less clear. In 2020, the FDA’s Oncology Center of Excellence (OCE) and the Critical Path Institute (C-Path) co-sponsored a 2-hour virtual roundtable session to discuss this specific issue. In this article, we summarize key points from this discussion with 16 stakeholders representing academia, clinical practice, patients, international regulatory agencies, health technology assessment bodies/payers, industry, and PRO instrument development. Stakeholders recognized that any PRO data collection after treatment discontinuation should have clearly defined objectives to ensure that data can be analyzed and reported. Data collection following discontinuation without a justification for its use wastes patients’ time and effort and is unethical.
AB - Patient-reported outcome (PRO) data are critical in understanding treatments from the patient perspective in cancer clinical trials. The potential benefits and methodological approaches to the collection of PRO data following treatment discontinuation (e.g., due to progressive disease or unacceptable drug toxicity) are less clear. In 2020, the FDA’s Oncology Center of Excellence (OCE) and the Critical Path Institute (C-Path) co-sponsored a 2-hour virtual roundtable session to discuss this specific issue. In this article, we summarize key points from this discussion with 16 stakeholders representing academia, clinical practice, patients, international regulatory agencies, health technology assessment bodies/payers, industry, and PRO instrument development. Stakeholders recognized that any PRO data collection after treatment discontinuation should have clearly defined objectives to ensure that data can be analyzed and reported. Data collection following discontinuation without a justification for its use wastes patients’ time and effort and is unethical.
U2 - 10.1016/j.jval.2023.06.019
DO - 10.1016/j.jval.2023.06.019
M3 - Article
SN - 1098-3015
JO - Value in Health
JF - Value in Health
ER -
