Issues and challenges with integrating patient-reported outcomes in clinical trials supported by the National Cancer Institute-sponsored clinical trials networks.
OBJECTIVE
The objective of this report is to provide a historical overview of and the issues and challenges inherent in the incorporation of patient-reported outcomes (PROs) into multinational cancer clinical trials in the cancer cooperative groups.


METHODS
An online survey of 12 cancer cooperative groups from the United States, Canada, and Europe was conducted between June and August of 2006. Each of the cooperative groups designated one respondent, who was a member of one of the PRO committees within the cooperative group.


RESULTS
There was a 100% response rate, and all of the cancer clinical trial cooperative groups reported conducting PRO research. PRO research has been conducted in the cancer cooperative groups for an average of 15 years (range, 6 to 30 years), and all groups had multidisciplinary committees focused on the design of PRO end points and the choice of appropriate PRO measures for cancer clinical trials. The cooperative groups reported that 5% to 50% of cancer treatment trials and an estimated 50% to 75% of cancer control trials contained PRO primary and secondary end points. There was considerable heterogeneity among the cooperative groups with respect to the formal and informal policies and procedures or cooperative group culture towards PROs, investigator training/mentorship, and resource availability for the measurement and conduct of PRO research within the individual cooperatives.


CONCLUSIONS
The challenges faced by the cooperative groups to the incorporation of PROs into cancer clinical trials are varied. Some common opportunities for improvement include the adoption of standardized training/mentorship mechanisms for investigators for the conduct of PRO assessments and data collection and the development of minimal criteria for PRO measure acceptability. A positive cultural shift has occurred in most of the cooperative groups related to the incorporation of PROs in clinical trials; however, financial and other resource barriers remain and need to be addressed.
Bruner
Deborah Watkins
DW
Radiation Therapy Oncology Group, University of Pennsylvania, School of Nursing; American College of Radiology Imaging Network, Philadelphia, PA 19104-6096, USA. wbruner@nursing .upenn.edu
Bryan
Charlene J
CJ
Aaronson
Neil
N
Blackmore
C Craig
CC
Brundage
Michael
M
Cella
David
D
Ganz
Patricia A
PA
Gotay
Carolyn
C
Hinds
Pamela S
PS
Kornblith
Alice B
AB
Movsas
Benjamin
B
Sloan
Jeff
J
Wenzel
Lari
L
Whalen
Giles
G
D002170:Canada; D002986:Clinical Trials as Topic; D003657:Decision Making; D005060:Europe; D006801:Humans; D015337:Multicenter Studies as Topic; D054547:National Cancer Institute (U.S.); D009369:Neoplasms / Q000628:therapy*; D017060:Patient Satisfaction; D019984:Quality Indicators, Health Care; D011788:Quality of Life; D018434:Sickness Impact Profile; D016896:Treatment Outcome; D014481:United States