Unfinished business: Terminated cancer trials and the relevance of treatment intent, sponsors and intervention types.
ClinicalTrials
cancer
terminated trials
trial recruitment
Journal
International journal of cancer
ISSN: 1097-0215
Titre abrégé: Int J Cancer
Pays: United States
ID NLM: 0042124
Informations de publication
Date de publication:
01 04 2021
01 04 2021
Historique:
received:
03
09
2020
revised:
05
10
2020
accepted:
06
10
2020
pubmed:
13
10
2020
medline:
6
8
2021
entrez:
12
10
2020
Statut:
ppublish
Résumé
The aim of the study was to report on the association of trial sponsors with intervention type, treatment intent, recruitment success and reasons to terminate cancer trials. The ClinicalTrials database was searched for interventional Phase 3 cancer trials (01/2006-05/2017). Noncancer studies and ongoing studies were excluded, permanently suspended studies were counted as terminated. Trials were stratified according to sponsors (industry/nonindustry), intervention type, setting (curative/palliative) and intent of intervention (curative/symptom-control/life-extending). We identified 345 terminated trials and 1137 completed studies as a control group. The frequency of premature termination did not differ significantly between sponsors. Time to termination was shorter but recruitment per month prior to termination was higher in industry-sponsored studies (7.0 vs 2.2 patients/month; P < .001). Drug interventions were more common in industry-sponsored, all other interventions in nonindustry-sponsored settings (P < .001). Life-extending palliative interventions occurred more frequently, symptom-control interventions in a curative setting less frequently in industry-sponsored trials (both P < .001). Intervention, setting and intent were not associated with termination in industry-sponsored trials. In nonindustry-sponsored trials, the frequency of drug interventions and life-extending (noncurative) interventions were increased in terminated trials (both P < .05); symptom-control interventions in curative settings occurred more frequently in completed studies. Industry-sponsored trials were more often terminated due to toxicity/inefficacy while lack of accrual occurred more frequently in nonindustry-sponsored trials (P < .01). Interventions, treatment setting/intent and reasons for termination differed between sponsor types. In nonindustry-sponsored trials, drug interventions and life-extending (noncurative) interventions were associated with premature termination and symptom-control interventions (curative setting) were associated with trial completion.
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
1676-1684Informations de copyright
© 2020 The Authors. International Journal of Cancer published by John Wiley & Sons Ltd on behalf of Union for International Cancer Control.
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