Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov.
6095 Background: In 2007, it was mandated that all clinical trials must be registered with clinicaltrials.gov. A collaboration between the Food and Drug Administration (FDA) and Duke University, this study represents the first systematic assessment of the clinicaltrials.gov database. What is the portfolio of cancer studies? What insights can be gained about our contemporary research enterprise? METHODS: MeSH terms and submitted conditions were classified by clinical sub-specialists to group studies by disease state. After isolating oncology trials, basic descriptive statistics profiled trial designs, patient populations, and interventions. RESULTS: Of the 40,969 interventional studies registered after September 2007 with submitted conditions, 9,102 (22%) focused on oncology, the highest among all subspecialties. Of the interventions studied, 72% assessed medications. When compared to clinical trials in other diseases as shown in the table, more oncology trials are early phase (70% phase I or II in oncology vs 33% overall), single arm (65% vs 23%), and unblinded (88% vs 47%). In the subset of trials which reported actual accrual, oncology studies averaged 42 patients and non-oncology 60 patients. In terms of eligibility criteria, maximum age cut-offs were less frequent in oncology (25% vs 60%); the most common exclusion was age > 70 years. Oncology trials were more likely to have a data monitoring committee (DMC) (53% vs 38%), although less likely to provide information regarding the existence of a DMC (70% vs 85%). CONCLUSIONS: The clinicaltrials.gov database represents a unique opportunity to understand the scope of clinical trials in oncology. These data identify strengths and weaknesses in trial design and patient populations that need to be carefully addressed in an era of increasing focus on research design and comparative effectiveness research. [Table: see text].
Hirsch, BR; Califf, RM; Tasneem, A; Chiswell, K; Bolte, J; Schulman, KA; Abernethy, AP
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