• Medientyp: E-Artikel
  • Titel: Unfinished business : terminated cancer trials and the relevance of treatment intent, sponsors and intervention types
  • Beteiligte: Bürgy, Daniel [Verfasser:in]; Riedel, Julian [Verfasser:in]; Ehmann, Michael [Verfasser:in]; Grilli, Maurizio [Verfasser:in]; Hofheinz, Ralf-Dieter [Verfasser:in]
  • Erschienen: 2021
  • Erschienen in: International journal of cancer ; 148(2021), 7 vom: Apr., Seite 1676-1684
  • Sprache: Englisch
  • DOI: 10.1002/ijc.33342
  • Identifikator:
  • Schlagwörter: Cancer ; ClinicalTrials ; Terminated trials ; Trial recruitment
  • Entstehung:
  • Anmerkungen: First published: 12 October 2020
  • Beschreibung: 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). Non-cancer studies and ongoing studies were excluded, permanently suspended studies were counted as terminated. Trials were stratified according to sponsors (industry/non-industry), 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 v. 2.2 patients/month; p < 0.001). Drug interventions were more common in industry-sponsored, all other interventions in non-industry-sponsored settings (p < 0.001). Life-extending palliative interventions occurred more frequently, symptom-control interventions in a curative setting less frequently in industry-sponsored trials (both p < 0.001). Intervention, setting, and intent were not associated with termination in industry-sponsored trials. In non-industry-sponsored trials, the frequency of drug interventions and life-extending (non-curative) interventions were increased in terminated trials (both p < 0.05); 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 non-industry-sponsored trials (p < 0.01). Interventions, treatment setting/intent and reasons for termination differed between sponsor type. In non-industry-sponsored trials, drug interventions and life-extending (non-curative) interventions were associated with premature termination and symptom-control interventions (curative setting) were associated with trial completion.
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