Clinical outcome assessment trends in clinical trials-Contrasting oncology and non-oncology trials.
clinical trials
oncology
patient outcome assessment
patient-reported outcomes
quality of life
Journal
Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310
Informations de publication
Date de publication:
08 2023
08 2023
Historique:
revised:
30
05
2023
received:
18
03
2023
accepted:
28
06
2023
medline:
15
9
2023
pubmed:
8
7
2023
entrez:
8
7
2023
Statut:
ppublish
Résumé
Clinical outcome assessments (COAs) are key to patient-centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their incorporation in trial outcomes have lagged that of traditional survival and tumor responses. To understand the trends of COA use in oncology and the impact of landmark efforts to promote COA use, we computationally surveyed oncology clinical trials in ClinicalTrials.gov comparing them to the rest of the clinical research landscape. Oncology trials were identified using medical subject heading neoplasm terms. Trials were searched for COA instrument names obtained from PROQOLID. Regression analyses assessed chronological and design-related trends. Eighteen percent of oncology interventional trials initiated 1985-2020 (N = 35,415) reported using one or more of 655 COA instruments. Eighty-four percent of the COA-using trials utilized patient-reported outcomes, with other COA categories used in 4-27% of these trials. Likelihood of COA use increased with progressing trial phase (OR = 1.30, p < 0.001), randomization (OR = 2.32, p < 0.001), use of data monitoring committees (OR = 1.26, p < 0.001), study of non-FDA-regulated interventions (OR = 1.23, p = 0.001), and in supportive care versus treatment-focused trials (OR = 2.94, p < 0.001). Twenty-six percent of non-oncology trials initiated 1985-2020 (N = 244,440) reported COA use; they had similar COA-use predictive factors as oncology trials. COA use increased linearly over time (R = 0.98, p < 0.001), with significant increases following several individual regulatory events. While COA use across clinical research has increased over time, there remains a need to further promote COA use particularly in early phase and treatment-focused oncology trials.
Sections du résumé
BACKGROUND
Clinical outcome assessments (COAs) are key to patient-centered evaluation of novel interventions and supportive care. COAs are particularly informative in oncology where a focus on how patients feel and function is paramount, but their incorporation in trial outcomes have lagged that of traditional survival and tumor responses. To understand the trends of COA use in oncology and the impact of landmark efforts to promote COA use, we computationally surveyed oncology clinical trials in ClinicalTrials.gov comparing them to the rest of the clinical research landscape.
METHODS
Oncology trials were identified using medical subject heading neoplasm terms. Trials were searched for COA instrument names obtained from PROQOLID. Regression analyses assessed chronological and design-related trends.
RESULTS
Eighteen percent of oncology interventional trials initiated 1985-2020 (N = 35,415) reported using one or more of 655 COA instruments. Eighty-four percent of the COA-using trials utilized patient-reported outcomes, with other COA categories used in 4-27% of these trials. Likelihood of COA use increased with progressing trial phase (OR = 1.30, p < 0.001), randomization (OR = 2.32, p < 0.001), use of data monitoring committees (OR = 1.26, p < 0.001), study of non-FDA-regulated interventions (OR = 1.23, p = 0.001), and in supportive care versus treatment-focused trials (OR = 2.94, p < 0.001). Twenty-six percent of non-oncology trials initiated 1985-2020 (N = 244,440) reported COA use; they had similar COA-use predictive factors as oncology trials. COA use increased linearly over time (R = 0.98, p < 0.001), with significant increases following several individual regulatory events.
CONCLUSION
While COA use across clinical research has increased over time, there remains a need to further promote COA use particularly in early phase and treatment-focused oncology trials.
Identifiants
pubmed: 37421295
doi: 10.1002/cam4.6325
pmc: PMC10501237
doi:
Types de publication
Journal Article
Research Support, N.I.H., Intramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
16945-16957Informations de copyright
© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
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