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Clin Colon Rectal Surg 2014; 27(02): 065-070
DOI: 10.1055/s-0034-1376171
Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Establishing a Successful Clinical Research Program

Daniele Scoglio
1   Department of Surgery, University of Washington Medical Center, Seattle, Washington
,
Alessandro Fichera
1   Department of Surgery, University of Washington Medical Center, Seattle, Washington
› Author Affiliations
Further Information

Publication History

Publication Date:
09 June 2014 (online)

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Abstract

Clinical research (CR) is a natural corollary to clinical surgery. It gives an investigator the opportunity to critically review their results and develop new strategies. This article covers the critical factors and the important components of a successful CR program. The first and most important step is to build a dedicated research team to overcome time constraints and enable a surgical practice to make CR a priority. With the research team in place, the next step is to create a program on the basis of an original idea and new clinical hypotheses. This often comes from personal experience supported by a review of the available evidence. Randomized controlled (clinical) trials are the most stringent way of determining whether a cause–effect relationship exists between the intervention and the outcome. In the proper setting, translational research may offer additional avenues allowing clinical application of basic science discoveries.

Keywords

clinical research program - clinical research team - randomized controlled (clinical) trial - evidence-based medicine - translational research
 

  • References

  • 1 Zon R. Role of the Oncology Team. Presented at the International Clinical Trials Workshop, Cairo, Egypt. Available at: http://www.semco-oncology.info/6-SEMCO_Download.html . Accessed January 27–28, 2011
    PubMedGoogle Scholar
  • 2 Emanuel EJ, Schnipper LE, Kamin DY, Levinson J, Lichter AS. The costs of conducting clinical research. J Clin Oncol 2003; 21 (22) 4145-4150
    CrossrefPubMedGoogle Scholar
  • 3 National Cancer Institute. Community clinical oncology program. Available at: http://prevention.cancer.gov/programs-resources/programs/ccop/about/facts#4 . Accessed on November 13, 2009.
    PubMedGoogle Scholar
  • 4 American Society of Clinical Oncology. Grants and awards. Available at: http://www.asco.org/ASCOv2/Research_Resources/Grants_%26_Awards . Accessed on November 13, 2009.
    PubMedGoogle Scholar
  • 5 Cochrane A. Effectiveness and efficiency. Random Reflections on Health Services. London: Nuffield Provincial Hospitals Trust; 1972
    Google Scholar
  • 6 Sackett DL, Rosenberg WM, Gray JA, Haynes RB, Richardson WS. Evidence based medicine: what it is and what it isn't. BMJ 1996; 312 (7023) 71-72
    Google Scholar
  • 7 Evidence-Based Medicine Working Group. Evidence-based medicine. A new approach to teaching the practice of medicine. JAMA 1992; 268 (17) 2420-2425
    CrossrefPubMedGoogle Scholar
  • 8 Lindberg DA, Humphreys BL. Medicine and health on the Internet: the good, the bad, and the ugly. JAMA 1998; 280 (15) 1303-1304
    CrossrefPubMedGoogle Scholar
  • 9 Grimes DA, Schulz KF. Descriptive studies: what they can and cannot do. Lancet 2002; 359 (9301) 145-149
    CrossrefPubMedGoogle Scholar
  • 10 Brighton B, Bhandari M, Tornetta III P, Felson DT. Hierarchy of evidence: from case reports to randomized controlled trials. Clin Orthop Relat Res 2003; (413) 19-24
    PubMedGoogle Scholar
  • 11 McCulloch P, Taylor I, Sasako M, Lovett B, Griffin D. Randomised trials in surgery: problems and possible solutions. BMJ 2002; 324 (7351) 1448-1451
    CrossrefPubMedGoogle Scholar
  • 12 Carey TS, Boden SD. A critical guide to case series reports. Spine 2003; 28 (15) 1631-1634
    PubMedGoogle Scholar
  • 13 Kooistra B, Dijkman B, Einhorn TA, Bhandari M. How to design a good case series. J Bone Joint Surg Am 2009; 91 (Suppl. 03) 21-26
    CrossrefPubMedGoogle Scholar
  • 14 Sibbald B, Roland M. Understanding controlled trials. Why are randomised controlled trials important?. BMJ 1998; 316 (7126) 201
    CrossrefPubMedGoogle Scholar
  • 15 Bowling A. Researching Methods in Health: Investigating Health and Health Services. Buckingham: Open University Press; 1997
    Google Scholar
  • 16 Begg C, Cho M, Eastwood S , et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA 1996; 276 (8) 637-639
    CrossrefPubMedGoogle Scholar
  • 17 Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias. Dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273 (5) 408-412
    CrossrefPubMedGoogle Scholar
  • 18 Mohtadi NG, Hollinshead RM, Ceponis PJ, Chan DS, Fick GH. A multi-centre randomized controlled trial comparing electrothermal arthroscopic capsulorrhaphy versus open inferior capsular shift for patients with shoulder instability: protocol implementation and interim performance: lessons learned from conducting a multi-centre RCT [ISRCTN68224911; NCT00251160]. Trials 2006; 7: 4
    CrossrefPubMedGoogle Scholar
  • 19 Pearson A, Jordan Z, Munn Z. Translational science and evidence-based healthcare: a clarification and reconceptualization of how knowledge is generated and used in healthcare. Nurs Res Pract 2012; 2012: 792519
    PubMedGoogle Scholar