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Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov

  • Healthcare Policy and Outcomes
  • Published:
Annals of Surgical Oncology Aims and scope Submit manuscript

Abstract

Background

The objective of this study was to provide a descriptive analysis of registered clinical trials in surgical oncology at ClinicalTrials.gov.

Methods

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.

Results

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 %).

Conclusions

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.

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References

  1. American Society of Clinical Oncology Mission Statement. http://www.asco.org/ASCOv2/About+ASCO/ASCO+Information/Mission+Statement. Accessed Feb 9 2013.

  2. National Cancer Institute Mission Statement. http://www.cancer.gov/aboutnci/overview/mission. Accessed Feb 9 2013.

  3. 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.

    Article  PubMed  Google Scholar 

  4. Wente MN, Seiler CM, Uhl W, Büchler MW. Perspectives of evidence-based surgery. Dig Surg. 2003;20:263–9.

    Article  PubMed  Google Scholar 

  5. Howes N, Chagla L, Thorpe M, McCulloch P. Surgical practice is evidence based. Br J Surg. 1997;84:1220–3.

    Article  PubMed  CAS  Google Scholar 

  6. Ellis J, Mulligan I, Rowe J, Sackett DL. Inpatient general medicine is evidence based. Lancet. 1995;364:407–10.

    Google Scholar 

  7. ClinicalTrials.gov registry. http://www.clinicaltrials.gov/. Accessed Feb 29 2012.

  8. 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.

    Article  PubMed  Google Scholar 

  9. 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.

    Article  PubMed  Google Scholar 

  10. 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.

    Article  PubMed  Google Scholar 

  11. 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.

    Article  PubMed  Google Scholar 

  12. National Institutes of Health. National Cancer Institute. Common Cancer Types. http://cancer.gov/cancertopics/types/commoncancers. Accessed Mar 2 2012.

  13. 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.

    Article  PubMed  Google Scholar 

  14. 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.

    Article  PubMed  Google Scholar 

  15. International Standard Randomised Controlled Trial Number (ISRCTN) registry. http://www.controlled-trials.com/isrctn/search.html. Accessed Feb 29 2012.

  16. 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.

    Article  PubMed  CAS  Google Scholar 

  17. metaRegister of Controlled Trials (mRCT). http://www.controlled-trials.com/mrct/. Accessed Feb 29 2012.

  18. 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.

    Article  PubMed  CAS  Google Scholar 

  19. Zarin DA, Tse T, Ide NC. Trial registration at clinicaltrials.gov between May and October 2005. N Engl J Med. 2005;353:2779–87.

    Article  PubMed  CAS  Google Scholar 

  20. 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.

    Article  PubMed  Google Scholar 

  21. 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.

    Article  PubMed  CAS  Google Scholar 

  22. Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One. 2011;6:e14701.

    Article  PubMed  CAS  Google Scholar 

  23. 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.

  24. 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.

    Article  PubMed  Google Scholar 

  25. 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.

    Article  PubMed  Google Scholar 

  26. 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.

    Article  PubMed  CAS  Google Scholar 

  27. 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.

    Article  PubMed  Google Scholar 

  28. 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.

    Article  PubMed  CAS  Google Scholar 

  29. 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.

    Article  PubMed  CAS  Google Scholar 

  30. 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.

    Article  PubMed  CAS  Google Scholar 

  31. 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.

    Article  PubMed  CAS  Google Scholar 

  32. 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.

    Article  PubMed  Google Scholar 

  33. Cook JA. The challenges faced in the design, conduct and analysis of surgical randomised controlled trials. Trials. 2009;10:9.

    Article  PubMed  Google Scholar 

  34. 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.

    PubMed  CAS  Google Scholar 

  35. Young JM, Solomon MJ, Harrison JD, Salkeld G, Butow P. Measuring patient preference and surgeon choice. Surgery. 2008;143:582–8.

    Article  PubMed  Google Scholar 

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Disclosure

This manuscript has not previously been published, nor has it been submitted to any other journal for consideration of publication. This manuscript is intended to analyze registered clinical trials in surgical oncology within clinicaltrials.gov. None of the authors have any financial support, any commercial interest in the subject of the study, or any involvement with an organization with a financial interest in this topic.

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Authors and Affiliations

  1. Division of General Surgery, Department of Surgery, University of Ottawa, Ottawa, ON, Canada

    Amber S. Menezes MD, Alison Barnes MD, Adena S. Scheer MD, MSc, FRCS(C), Guillaume Martel MD, MSc, FRCS(C), Husein Moloo MD, MSc, FRCS(C), Robin P. Boushey MD, PhD, CIP, FRCS(C) & Rebecca C. Auer MD, MSc, FRCS(C)

  2. The Ottawa Hospital Research Institute, Ottawa, ON, Canada

    Robin P. Boushey MD, PhD, CIP, FRCS(C), Elham Sabri MSc & Rebecca C. Auer MD, MSc, FRCS(C)

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  1. Amber S. Menezes MD
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  2. Alison Barnes MD
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  3. Adena S. Scheer MD, MSc, FRCS(C)
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  4. Guillaume Martel MD, MSc, FRCS(C)
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  5. Husein Moloo MD, MSc, FRCS(C)
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  6. Robin P. Boushey MD, PhD, CIP, FRCS(C)
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  8. Rebecca C. Auer MD, MSc, FRCS(C)
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Corresponding author

Correspondence to Rebecca C. Auer MD, MSc, FRCS(C).

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Menezes, A.S., Barnes, A., Scheer, A.S. et al. Clinical Research in Surgical Oncology: An Analysis of ClinicalTrials.gov. Ann Surg Oncol 20, 3725–3731 (2013). https://doi.org/10.1245/s10434-013-3054-y

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  • DOI: https://doi.org/10.1245/s10434-013-3054-y

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