TY - JOUR
T1 - Practice and policy of measuring quality of life and health economics in cancer clinical trials
T2 - A survey among co-operative trial groups
AU - Kiebert, G.
AU - Wait, S.
AU - Bernhard, J.
AU - Bezjak, A.
AU - Cella, D.
AU - Day, R.
AU - Houghton, J.
AU - Moinpour, C.
AU - Scott, C.
AU - Stephens, R.
N1 - Funding Information:
This study was supported from an unrestricted financial grant from Novartis Pharma AG.
PY - 2000
Y1 - 2000
N2 - Background: Co-operative groups have played an important role in the advance of health-related quality of life (HRQL) research. However, definitions of the concept, criteria for selection of existing instruments and methods for data collection and interpretation remain poorly defined in the literature. A survey was conducted amongst the major cancer co-operative groups in order to gain a better understanding of their current policy and processes to ensure optimal HRQL data collection within cancer clinical trials. The topic of health economics was similarly addressed. Methods: A written questionnaire was addressed to 16 major European and North American cancer co-operative groups. Eleven groups responded (response rate: 69%), however, one group could not provide information for the survey, thus ten questionnaires were available for analysis. Results: The results from this survey among co-operative groups show that HRQL (more than health economics) is recognized as an important, although usually secondary, outcome measure in oncology trials. On the whole, co-operative groups have a rather flexible policy towards the inclusion of HRQL (and HE) into their clinical trials, and practice is very much on a case-by-case basis, but use standard practice guidelines and internal procedures is to ensure well-defined study protocols and enhance good quality studies.
AB - Background: Co-operative groups have played an important role in the advance of health-related quality of life (HRQL) research. However, definitions of the concept, criteria for selection of existing instruments and methods for data collection and interpretation remain poorly defined in the literature. A survey was conducted amongst the major cancer co-operative groups in order to gain a better understanding of their current policy and processes to ensure optimal HRQL data collection within cancer clinical trials. The topic of health economics was similarly addressed. Methods: A written questionnaire was addressed to 16 major European and North American cancer co-operative groups. Eleven groups responded (response rate: 69%), however, one group could not provide information for the survey, thus ten questionnaires were available for analysis. Results: The results from this survey among co-operative groups show that HRQL (more than health economics) is recognized as an important, although usually secondary, outcome measure in oncology trials. On the whole, co-operative groups have a rather flexible policy towards the inclusion of HRQL (and HE) into their clinical trials, and practice is very much on a case-by-case basis, but use standard practice guidelines and internal procedures is to ensure well-defined study protocols and enhance good quality studies.
KW - Cancer
KW - Co-operative group
KW - Health economics
KW - Quality of life
KW - Randomized controlled clinical trials
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U2 - 10.1023/A:1016658004947
DO - 10.1023/A:1016658004947
M3 - Article
C2 - 11401040
AN - SCOPUS:17744393848
VL - 9
SP - 1073
EP - 1080
JO - Quality of Life Research
JF - Quality of Life Research
SN - 0962-9343
IS - 10
ER -