Unfinished business: Terminated cancer trials and the relevance of treatment intent, sponsors and intervention types. Issue 7 (21st October 2020)

• Record Type: Journal Article
• Authors: Buergy, Daniel; Riedel, Julian; Sarria, Gustavo R.; Ehmann, Michael; Scafa, Davide; Grilli, Maurizio; Wenz, Frederik; Hofheinz, Ralf D.
• Is Part Of: International journal of cancer. Volume 148:Issue 7(2021)
• Page Start: 1676
• Page End: 1684
• Publication Date: 2020-10-21
• Subjects: cancer -- ClinicalTrials -- terminated trials -- trial recruitment; Cancer -- Periodicals; Cancer -- Prevention -- Periodicals; 616.994
• DOI: 10.1002/ijc.33342
• Languages: English
• ISSNs: 0020-7136

Abstract

Abstract: 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. Abstract : What's new? Industry sponsorship of clinical trials to investigate novel cancer treatment strategies in patients has grown significantly in recent decades. Little is known, however, about the termination and completion rates of industry‐sponsored trials. Here, terminated and completed late‐stage cancer trials were analyzed and stratified by sponsor type. Termination frequency of trials was found to be similar between industry sponsors and other sponsors. In addition, industry‐sponsored trials had a shorter time to termination but recruited participants more quickly than trials sponsored by other entities. Commonly observed reasons for termination in industry‐sponsored trials included issues concerning lack of efficacy or toxicity.