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Clinical Trials: Ensuring Quality and Standardization

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Clinical Trials

Part of the book series: Success in Academic Surgery ((SIAS))

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Abstract

The number of clinical trials in the United States and worldwide is increasing rapidly. ClinicalTrials.gov, which started in the year 2000, registered a total of 2119 trials, whereas in 2019, that number is 309,531, which is nearly a 150-fold increase [1]. Of the 309,531 trials registered in 2019, 244,831 (79%) are interventional, with 25,857 - or approximately 11% - involving a surgical procedure. With this rise in the number of clinical trials, there is an increased need to ensure that human subjects research being conducted is done in a manner that is ethical and the data collected, analyzed, and reported are of high quality and transparent. To meet this need, organizations ranging from academic centers to large consortia that conduct clinical trials to the National Institutes of Health now have implemented training programs and defined standards for all professionals participating in the conduct of clinical trials. We will review some of these standards, as well as other components of clinical trials to ensure quality and standardization.

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References

  1. Clinical Trials—trends, charts and maps. https://clinicaltrials.gov/ct2/resources/trends.

  2. E6(R2) Good clinical practice: integrated addendum to ICH E6(R1). U.S. Food and Drug Administration. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/e6r2-good-clinical-practice-integrated-addendum-ich-e6r1.

  3. E6(R2) Good clinical practice: integrated addendum to E6(R1); International Council for Harmonisation; Guidance for Industry; Availability. https://www.regulations.gov/document?D=FDA-2018-D-0719-0001.

  4. CITI program. https://about.citiprogram.org/en/mission-and-history/.

  5. National Institutes of Health—policy and compliance. https://grants.nih.gov/policy/clinical-trials/good-clinical-training.htm.

  6. Policy on good clinical practice training for NIH awardees involved in NIH-funded clinical trials. 2016. National Institutes of Health (NIH). https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html.

  7. NCI guidelines: adverse event reporting requirements. https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/aeguidelines.pdf.

  8. 21 CFR 312.64b, 21 CFR 812 (code of federal regulation title 21). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=312.64.

  9. Di Maio M, Gallo C, Leighl NB, Piccirillo MC, Daniele G, Nuzzo F, et al. Symptomatic toxicities experienced during anticancer treatment: agreement between patient and physician reporting in three randomized trials. J Clin Oncol. 2015;33(8):910–5. https://doi.org/10.1200/JCO.2014.57.9334.

    Article  CAS  PubMed  Google Scholar 

  10. Fromme EK, Eilers KM, Mori M, Hsieh YC, Beer TM. How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30. J Clin Oncol. 2004;22(17):3485–90. https://doi.org/10.1200/JCO.2004.03.025.

    Article  PubMed  Google Scholar 

  11. Montemurro F, Mittica G, Cagnazzo C, Longo V, Berchialla P, Solinas G, et al. Self-evaluation of adjuvant chemotherapy-related adverse effects by patients with breast cancer. JAMA Oncol. 2016;2(4):445–52. https://doi.org/10.1001/jamaoncol.2015.4720.

    Article  PubMed  Google Scholar 

  12. Basch E, Reeve BB, Mitchell SA, Clauser SB, Minasian LM, Dueck AC, et al. Development of the National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE). J Natl Cancer Inst. 2014;106(9) https://doi.org/10.1093/jnci/dju244.

  13. Sajdak R, Trembath L, Thomas KS. The importance of standard operating procedures in clinical trials. J Nucl Med Technol. 2013;41(3):231–3. https://doi.org/10.2967/jnmt.113.121467.

    Article  PubMed  Google Scholar 

  14. ICH guidance E6: good clinical practice: consolidated guideline. US HHS, US FDA, CDER, CBER. 1996. http://www.fda.gov/downloads/Drugs/Guidances/ucm073122.pdf. Accessed 11 Jun 2013.

  15. Bellary S, Krishnankutty B, Latha MS. Basics of case report form designing in clinical research. Perspect Clin Res. 2014;5(4):159–66. https://doi.org/10.4103/2229-3485.140555.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Good clinical data management practices. Belgium: Society for Clinical Data Management; 2009. Accessed 17 Jun 2013. http://www.swaggerinfosolutions.pro/sridevi/New%20Folder/ICRI/GCDMP_complete_OCT2009.pdf.

  17. OnCore enterprise research CTMS. Forte. https://forteresearch.com/enterprise-research-oncore/.

  18. eRegulatory solution for high-performing clinical research sites. Complion. https://complion.com/.

  19. Holubkov R, Casper TC, Dean JM, Anand KJ, Zimmerman J, Meert KL, et al. The role of the Data and Safety Monitoring Board in a clinical trial: the CRISIS study. Pediatr Crit Care Med. 2013;14(4):374–83. https://doi.org/10.1097/PCC.0b013e318274568c.

    Article  PubMed  PubMed Central  Google Scholar 

  20. Piantadosi S. Clinical trials: a methodologic perspective. New York: John Wiley & Sons; 2005.

    Book  Google Scholar 

  21. Begg C, Cho M, Eastwood S, Horton R, Moher D, Olkin I, et al. Improving the quality of reporting of randomized controlled trials. The CONSORT statement. JAMA. 1996;276(8):637–9.

    Article  CAS  Google Scholar 

  22. Moher D, Jones A, Lepage L, CONSORT Group. Use of the CONSORT statement and quality of reports of randomized trials: a comparative before-and-after evaluation. JAMA. 2001;285(15):1992–5.

    Article  CAS  Google Scholar 

  23. Plint AC, Moher D, Morrison A, Schulz K, Altman DG, Hill C, et al. Does the CONSORT checklist improve the quality of reports of randomised controlled trials? A systematic review. Med J Aust. 2006;185(5):263–7.

    Article  Google Scholar 

  24. Turner L, Shamseer L, Altman DG, Weeks L, Peters J, Kober T, et al. Consolidated standards of reporting trials (CONSORT) and the completeness of reporting of randomised controlled trials (RCTs) published in medical journals. Cochrane Database Syst Rev. 2012;11:MR000030. https://doi.org/10.1002/14651858.MR000030.pub2.

  25. Devereaux PJ, Manns BJ, Ghali WA, Quan H, Guyatt GH. The reporting of methodological factors in randomized controlled trials and the association with a journal policy to promote adherence to the Consolidated Standards of Reporting Trials (CONSORT) checklist. Control Clin Trials. 2002;23(4):380–8.

    Article  CAS  Google Scholar 

  26. Shamseer L, Hopewell S, Altman DG, Moher D, Schulz KF. Update on the endorsement of CONSORT by high impact factor journals: a survey of journal “Instructions to Authors” in 2014. Trials. 2016;17(1):301. https://doi.org/10.1186/s13063-016-1408-z.

    Article  PubMed  PubMed Central  Google Scholar 

  27. 21 CFR 11. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=11.

  28. 21 CFR 312.32–33. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRsearch.cfm?CFRPart=312.

  29. 21 CFR 312.56. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.56.

  30. Cuccia M. How to advance your career through clinical research certification. Forte. https://forteresearch.com/news/how-to-advance-your-career-through-clinical-research-certification/.

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Author information

Authors and Affiliations

  1. Division of Surgical Oncology, Department of Surgery, Emory University School, Atlanta, GA, USA

    Mihir M. Shah

  2. Division of Surgical Oncology, Department of Surgery, University of Rochester, Rochester, NY, USA

    Darren R. Carpizo

Authors
  1. Mihir M. Shah
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  2. Darren R. Carpizo
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Correspondence to Darren R. Carpizo .

Editor information

Editors and Affiliations

  1. Chair, Department of Surgery The Urban Meyer III and Shelley Meyer Chair for Cancer Research, The Ohio State University Wexner Medical, Columbus, OH, USA

    Timothy M. Pawlik

  2. Leon Goldman, MD Distinguished Professor of Surgery and Chair Department of Surgery, University of California, San Francisco, San Francisco, CA, USA

    Julie A. Sosa

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Shah, M.M., Carpizo, D.R. (2020). Clinical Trials: Ensuring Quality and Standardization. In: Pawlik, T., Sosa, J. (eds) Clinical Trials. Success in Academic Surgery. Springer, Cham. https://doi.org/10.1007/978-3-030-35488-6_7

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  • DOI: https://doi.org/10.1007/978-3-030-35488-6_7

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  • Publisher Name: Springer, Cham

  • Print ISBN: 978-3-030-35487-9

  • Online ISBN: 978-3-030-35488-6

  • eBook Packages: MedicineMedicine (R0)

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