Skip to main content

Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov.

Publication ,  Journal Article
Hirsch, BR; Califf, RM; Tasneem, A; Chiswell, K; Bolte, J; Schulman, KA; Abernethy, AP
Published in: J Clin Oncol
May 20, 2011

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].

Duke Scholars

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

May 20, 2011

Volume

29

Issue

15_suppl

Start / End Page

6095

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Hirsch, B. R., Califf, R. M., Tasneem, A., Chiswell, K., Bolte, J., Schulman, K. A., & Abernethy, A. P. (2011). Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov. J Clin Oncol, 29(15_suppl), 6095.
Hirsch, B. R., R. M. Califf, A. Tasneem, K. Chiswell, J. Bolte, K. A. Schulman, and A. P. Abernethy. “Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov.J Clin Oncol 29, no. 15_suppl (May 20, 2011): 6095.
Hirsch BR, Califf RM, Tasneem A, Chiswell K, Bolte J, Schulman KA, et al. Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov. J Clin Oncol. 2011 May 20;29(15_suppl):6095.
Hirsch, B. R., et al. “Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov.J Clin Oncol, vol. 29, no. 15_suppl, May 2011, p. 6095.
Hirsch BR, Califf RM, Tasneem A, Chiswell K, Bolte J, Schulman KA, Abernethy AP. Assessment of clinical trials in oncology: An evaluation of 40,696 trials on ClinicalTrials.gov. J Clin Oncol. 2011 May 20;29(15_suppl):6095.

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

May 20, 2011

Volume

29

Issue

15_suppl

Start / End Page

6095

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 3211 Oncology and carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences