International Society for Quality of Life Research commentary on the US Food and Drug Administration draft guidance for industry on core patient-reported outcomes in cancer clinical trials.

Brady, Keri J S; Peipert, John Devin; Atkinson, Thomas M; Pompili, Cecilia; Pinto, Monica; Shaw, James W; Roydhouse, Jessica

Brady, Keri J S; Peipert, John Devin; Atkinson, Thomas M; Pompili, Cecilia; Pinto, Monica; Shaw, James W; Roydhouse, Jessica.

Affiliation

Brady KJS; Sanofi, Cambridge, MA, USA.
Peipert JD; Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
Atkinson TM; Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Pompili C; Patient-Centred Outcomes Research (PCOR), University of Leeds, Leeds, UK.
Pinto M; Rehabilitation Medicine Unit, Istituto Nazionale Tumori - IRCCS - Fondazione G. Pascale, Naples, Italy.
Shaw JW; Bristol Myers Squibb, Lawrenceville, NJ, USA.
Roydhouse J; Menzies Institute for Medical Research, University of Tasmania, Hobart, TAS, Australia. jessica.roydhouse@utas.edu.au.

Qual Life Res ; 32(8): 2155-2163, 2023 Aug.

Article in En | MEDLINE | ID: mdl-37217665

Subject(s)

Neoplasms; Quality of Life; United States; Humans; Quality of Life/psychology; United States Food and Drug Administration; Patient Reported Outcome Measures; Neoplasms/drug therapy; Medical Oncology

Key words

Clinical outcome assessment; Guidance; Oncology; Patient-reported outcomes; Trial

Fulltext

Add to My VHL

XML

PubMed Links

Search on Google

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Quality of Life / Neoplasms Type of study: Guideline / Health_technology_assessment Aspects: Patient_preference Limits: Humans Country/Region as subject: America do norte Language: En Journal: Qual Life Res Journal subject: REABILITACAO / TERAPEUTICA Year: 2023 Document type: Article Affiliation country: United States Country of publication: Netherlands

Fulltext

Add to My VHL

XML

PubMed Links

Search on Google