Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov
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The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov.
Data was extracted from ClinicalTrials.gov using the following search engine criteria: “Cancer” as Condition, “Surgery OR Operation OR Resection” as Intervention, and Non-Industry sponsored. The search was limited to Canada and the United States and included trials registered from January 1, 2001 to January 1, 2011.
Of 9,961 oncology trials, 1,049 (10.5 %) included any type of surgical intervention. Of these trials, 125 (11.9 %, 1.3 % of all oncology trials) assessed a surgical variable, 773 (73.7 %) assessed adjuvant/neoadjuvant therapies, and 151 (14.4 %) were observational studies. Of the trials assessing adjuvant therapies, systemic treatment (362 trials, 46.8 %) and multimodal therapy (129 trials, 16.7 %) comprised a large focus. Of the 125 trials where surgery was the intervention, 59 trials (47.2 %) focused on surgical techniques or devices, 45 trials (36.0 %) studied invasive diagnostic methods, and 21 trials (16.8 %) evaluated surgery versus no surgery. The majority of the 125 trials were nonrandomized (72, 57.6 %).
The number of registered surgical oncology trials is small in comparison to oncology trials as a whole. Clinical trials specifically designed to assess surgical interventions are vastly outnumbered by trials focusing on adjuvant therapies. Randomized surgical oncology trials account for <1 % of all registered cancer trials. Barriers to the design and implementation of randomized trials in surgical oncology need to be clarified in order to facilitate higher-level evidence in surgical decision-making.
- American Society of Clinical Oncology Mission Statement. http://www.asco.org/ASCOv2/About+ASCO/ASCO+Information/Mission+Statement. Accessed Feb 9 2013.
- National Cancer Institute Mission Statement. http://www.cancer.gov/aboutnci/overview/mission. Accessed Feb 9 2013.
- Panesar SS, Thakrar R, Athanasiou T, Sheikh A. Comparison of reports of randomized controlled trials and systematic reviews in surgical journals: literature review. J R Soc Med. 2006;99:470–2. CrossRef
- Wente MN, Seiler CM, Uhl W, Büchler MW. Perspectives of evidence-based surgery. Dig Surg. 2003;20:263–9. CrossRef
- Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg. 1997;84:1220–3. CrossRef
- Ellis J, Mulligan I, Rowe J, Sackett DL. Inpatient general medicine is evidence based. Lancet. 1995;364:407–10.
- ClinicalTrials.gov registry. http://www.clinicaltrials.gov/. Accessed Feb 29 2012.
- Bailey CS, Fehlings MG, Rampersaud YR, Hall H, Wai EK, Fisher CG, et al. Industry and evidence-based medicine: believable or conflicted? A systematic review of the surgical literature. Can J Surg. 2011;54:321–6. CrossRef
- Okike K, Kocher MS, Mehlman CT, Bhandari M. Conflict of interest in orthopaedic research: an association between findings and fundings in scientific presentations. J Bone Joint Surg. 2007;89:608–13. CrossRef
- Pitak-Arnnop P, Sader R, Rapidis AD, Dhanuthai K, Bauer U, Herve C, et al. Publication bias in oral and maxillofacial surgery journals: an observation on published controlled trials. J Craniomaxillofac Surg. 2010;38:4–10. CrossRef
- Kanaan Z, Galandiuk S, Abby M, Shannon KV, Dajani D, Hicks N, et al. The value of lesser-impact-factor surgical journals as a source of negative and inconclusive outcomes reporting. Ann Surg. 2011;253:619–23. CrossRef
- National Institutes of Health. National Cancer Institute. Common Cancer Types. http://cancer.gov/cancertopics/types/commoncancers. Accessed Mar 2 2012.
- McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D, et al. Randomised trials in surgery: problems and possible solutions. BMJ. 2002;324:1448–51. CrossRef
- Sekeres M, Gold JL, Chan A, Lexchin J, Moher D, Van Laethem ML, et al. Poor reporting of scientific leadership information in clinical trial registers. PLoS One. 2008;3:e1610. CrossRef
- International Standard Randomised Controlled Trial Number (ISRCTN) registry. http://www.controlled-trials.com/isrctn/search.html. Accessed Feb 29 2012.
- Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The clinicaltrials.gov results database – update and key issues. N Engl J Med. 2011;364:852–60. CrossRef
- metaRegister of Controlled Trials (mRCT). http://www.controlled-trials.com/mrct/. Accessed Feb 29 2012.
- Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. Characteristics of clinical trials registered in clinicaltrials.gov, 2007–2010. JAMA. 2012;307:1838–47. CrossRef
- Zarin DA, Tse T, Ide NC. Trial registration at clinicaltrials.gov between May and October 2005. N Engl J Med. 2005;353:2779–87. CrossRef
- Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in clinicaltrials.gov: a cross-sectional analysis. PLoS Med. 2009;6:e1000144. CrossRef
- Huic M, Marusic M, Marusic A. Completeness and changes in registered data and reporting bias of randomized controlled trials in ICMJE journals after trial registration policy. PLoS One. 2011;6:e25258. CrossRef
- Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One. 2011;6:e14701. CrossRef
- World Health Organization. International Clinical Trials Registry Platform. Trial registration data set. http://www.who.int/ictrp/network/trds/en/index.html. Accessed Feb 29, 2012.
- Ramsey S, Scoggins J. Practicing on the tip of an information iceberg? Evidence of underpublication of registered clinical trials in oncology. Oncologist. 2008;13:925–9. CrossRef
- Van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, et al. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000;92:1143–50. CrossRef
- Jayne DG, Thorpe HC, Copeland J, Quirke P, Brown JM, Guillou PJ. Five-year follow-up of the Medical Research Council CLASICC trial of laparoscopically assisted versus open surgery for colorectal cancer. Br J Surg. 2010;97:1638–45. CrossRef
- d’Amato TA, Ashrafi AS, Schuchert MJ, Alshehab DS, Seely AJ, Shamji FM, et al. Risk of pneumonectomy after induction therapy for locally advanced non-small cell lung cancer. Ann Thor Surg. 2009;88:1079–85. CrossRef
- Angarita FA, Acuna SA, Torregrosa L, Tawil M, Escallon J, Ruíz Á. Perioperative variables associated with surgical site infection in breast cancer surgery. J Hosp Infect. 2011;79:328–32. CrossRef
- Thornton AD, Ravn P, Winslet M, Chester K. Angiogenesis inhibition with bevacizumab and the surgical management of colorectal cancer. Br J Surg. 2006;93:1456–63. CrossRef
- Wright G, Manser RL, Byrnes G, Hart D, Campbell DA. Surgery for non-small cell lung cancer: systematic review and meta-analysis of randomised controlled trials. Thorax. 2006;61:597–603. CrossRef
- McLeod RS, Wright JG, Solomon MJ, Hu X, Walters BC, Lossing Al. Randomized controlled trials in surgery: issues and problems. Surgery. 1996;119:483–6. CrossRef
- Farrokhyar F, Karanicolas PJ, Thoma A, Simunovic M, Bhandari M, Devereaux PJ, et al. Randomized controlled trials of surgical interventions. Ann Surg. 2010;251:409–16. CrossRef
- Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009;10:9. CrossRef
- Ramsay CR, Grant AM, Wallace SA, Garthwaite PH, Monk AF, Russell IT. Statistical assessment of the learning curves of health technologies. Health Technol Assess. 2001;5:1–79.
- Young JM, Solomon MJ, Harrison JD, Salkeld G, Butow P. Measuring patient preference and surgeon choice. Surgery. 2008;143:582–8. CrossRef
- Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov
Annals of Surgical Oncology
Volume 20, Issue 12 , pp 3725-3731
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- Springer US
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- Author Affiliations
- 1. Division of General Surgery, Department of Surgery, University of Ottawa, Ottawa, ON, Canada
- 2. The Ottawa Hospital Research Institute, Ottawa, ON, Canada