Skip to main content
SpringerLink
Log in

Protocol Development and Preparation for a Clinical Trial

  • Chapter
  • First Online:
Principles of Research Methodology

  • 5651 Accesses

Abstract

A protocol is the most critical document in a research study. It plays a central role in the conduct of a study by describing how a hypothesis will be tested. It provides the necessary guidance and serves as the main reference for all study personnel, while also providing for the welfare and safety of all study participants; it must be prospective, detailed, and comprehensive. A protocol is organized in chronological divisions; the background and rationale provide the first impression of the investigators; study endpoints, especially the primary ones, drive the rest of the study design. The study population, methodological details, schedule of visits/procedures, and methods for ensuring patient safety must be described in detail, along with the study organization, administration, and anticipated results and significance. A high-quality protocol will more likely lead to a valid conclusion, whether it confirms or refutes the hypothesis, thereby reducing the likelihood of needing a costly repeat study.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 84.99
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 109.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 159.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

References

  1. Spilker B. Guide to clinical trials. New York: Raven; 1991.

    Google Scholar 

  2. Treweek S, McCormack K, Abalos E, Campbell M, Ramsay C, Zwarenstein M, PRACTIHC Collaboration. The trial protocol tool: the PRACTIHC software tool that supported the writing of protocols for pragmatic randomized controlled trials. J Clin Epidemiol. 2006;59:1127–33.

    Article  PubMed  Google Scholar 

  3. Sellier P, Chatellier G, D’Agrosa-Boiteux MC, Douard H, Dubois C, Goepfert PC, Monpère C, Saint Pierre A, Investigators of the PERISCOP study. Use of non-invasive cardiac investigations to predict clinical endpoints after coronary bypass graft surgery in coronary artery disease patients: results from the prognosis and evaluation of risk in the coronary operated patient (PERISCOP) study. Eur Heart J. 2003;24:916–26.

    Article  PubMed  Google Scholar 

  4. Mahaffey KW, Harrington RA, Akkerhuis M, Kleiman NS, Berdan LG, Crenshaw BS, Tardiff BE, Granger CB, DeJong I, Bhapkar M, Widimsky P, Corbalon R, Lee KL, Deckers JW, Simoons ML, Topol EJ, Califf RM, For the PURSUIT Investigators. Disagreements between central clinical events committee and site investigator assessments of myocardial infarction endpoints in an international clinical trial: review of the PURSUIT study. Curr Control Trials Cardiovasc Med. 2001;2:187–94.

    Article  PubMed  Google Scholar 

  5. Marang van de Mheen PJ, Hollander EJ, Kievit J. Effects of study methodology on adverse outcome occurrence and mortality. Int J Qual Health Care. 2007;19:399–406.

    Article  Google Scholar 

  6. Borgsteede SD, Deliens L, Francke AL, Stalman WA, Willems DL, van Eijk JT, van der Wal G. Defining the patient population: one of the problems for palliative care research. Palliat Med. 2006;20:63–8.

    Article  PubMed  Google Scholar 

  7. Chin Feman SP, Nguyen LT, Quilty MT, Kerr CE, Nam BH, Conboy LA, Singer JP, Park M, Lembo AJ, Kaptchuk TJ, Davis RB. Effectiveness of recruitment in clinical trials: an analysis of methods used in a trial for irritable bowel syndrome patients. Contemp Clin Trials. 2008;29:241–51.

    Article  PubMed  Google Scholar 

  8. Sisk JE, Horowitz CR, Wang JJ, McLaughlin MA, Hebert PL, Tuzzio L. The success of recruiting minorities, women, and elderly into a randomized controlled effectiveness trial. Mt Sinai J Med. 2008;75:37–43.

    Article  PubMed  Google Scholar 

  9. Armitage J, Souhami R, Friedman L, Hilbrich L, Holland J, Muhlbaier LH, Shannon J, Van Nie A. The impact of privacy and confidentiality laws on the conduct of clinical trials. Clin Trials. 2008;5:70–4.

    Article  PubMed  Google Scholar 

  10. Anisimov VV, Fedorov VV. Modelling, prediction and adaptive adjustment of recruitment in multicentre trials. Stat Med. 2007;26:4958–75.

    Article  PubMed  Google Scholar 

  11. Abbas I, Rovira J, Casanovas J. Clinical trial optimization: Monte Carlo simulation Markov model for planning clinical trials recruitment. Contemp Clin Trials. 2007;28:220–31.

    Article  PubMed  Google Scholar 

  12. Franciosa JA. Commentary on the use of run-in periods in clinical trials. Am J Cardiol. 1999;83:942–4.

    Article  PubMed  CAS  Google Scholar 

  13. Romano P. Automation of in-silico data analysis processes through workflow management systems. Brief Bioinform. 2008;9:57–68.

    Article  PubMed  Google Scholar 

  14. Lacroix Z. Biological data integration: wrapping data and tools. IEEE Trans Inf Technol Biomed. 2002;6:123–8.

    Article  PubMed  Google Scholar 

  15. Shah AR, Singhal M, Klicker KR, Stephan EG, Wiley HS, Waters KM. Enabling high-throughput data management for systems biology: the Bioin­formatics Resource Manager. Bioinformatics. 2007;23:906–9.

    Article  PubMed  CAS  Google Scholar 

  16. Nussenblatt RB, Meinert CL. The status of clinical trials: cause for concern. J Transl Med. 2010;8:65–8.

    Article  PubMed  Google Scholar 

  17. Smith A, Palmer S, Johnson DW, Navaneethan S, Valentini M, Strippoli GF. How to conduct a randomized trial. Nephrology. 2010;15:740–6.

    Article  PubMed  Google Scholar 

  18. Paschoale HS, Barbosa FR, Nita ME, Carrilho FJ, Ono-Nita SK. Clinical trials profile: professionals and sites. Contemp Clin Trials. 2010;31:438–42.

    Article  PubMed  Google Scholar 

  19. Bader JD, Robinson DS, Gilbert GH, Ritter AV, Makhija SK, Funkhouser KA, Amaechi BT, Shugars DA, Laws R. X-ACT collaborative research group. Four “lessons learned” while implementing a multi-site caries prevention trial. J Public Health Dent. 2010;70:171–5.

    Article  PubMed  Google Scholar 

  20. Treweek S, Pitkethly M, Cook J, Kjeldstrøm M, Taskila T, Johansen M, Sullivan F, Wilson S, Jackson C, Jones R, Mitchell E. Strategies to improve recruitment to randomised controlled trials. Cochrane Database Syst Rev. 2010;4:MR000013.

    PubMed  Google Scholar 

  21. Helgesson G, Ludvigsson J, Gustafsson Stolt U. How to handle informed consent in longitudinal studies when participants have a limited understanding of the study. J Med Ethics. 2005;31:670–3.

    Article  PubMed  CAS  Google Scholar 

  22. Jones JW, McCullough LB, Richman BW. Informed consent: it’s not just signing a form. Thorac Surg Clin. 2005;15:451–60.

    Article  PubMed  Google Scholar 

  23. Albrecht TL, Franks MM, Ruckdeschel JC. Communication and informed consent. Curr Opin Oncol. 2005;17:336–9.

    Article  PubMed  Google Scholar 

  24. del Carmen MG, Joffe S. Informed consent for medical treatment and research: a review. Oncologist. 2005;10:636–41.

    Article  PubMed  Google Scholar 

  25. Pocock SJ. Clinical trials: a practical approach. New York: Wiley; 1983.

    Google Scholar 

  26. Portney LG, Watkins MP. Foundations of clinical research: applications to practice. 2nd ed. New Jersey: Prentice-Hall; 2000.

    Google Scholar 

  27. Basic questions and answers about clinical trials. Rockville (MD): Food and Drug Administration (US). Last Updated: 07/16/2009. http://www.fda.gov/­forconsumers/byaudience/forpatientadvocates/­hivandaidsactivities/ucm121345.htm Accessed 11 Aug 2011.

  28. Piantadosi S. Clinical trials: a methodologic perspective. New York: Wiley; 1997.

    Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Medicine, State University of New York Downstate Medical Center, Brooklyn, NY, USA

    Joseph A. Franciosa MD

Authors
  1. Joseph A. Franciosa MD
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Joseph A. Franciosa MD .

Editor information

Editors and Affiliations

  1. , Cardiovascular Medicine, SUNY Downstate Medical Center, Clarkson Avenue, box 1199 450, Brooklyn, 11203, USA

    Phyllis G. Supino

  2. , Cardiovascualr Medicine, SUNY Downstate Medical Center, Clarkson Avenue 450, Brooklyn, 11203, USA

    Jeffrey S. Borer

Rights and permissions

Reprints and permissions

Copyright information

© 2012 Springer Science+Business Media, LLC

About this chapter

Cite this chapter

Franciosa, J.A. (2012). Protocol Development and Preparation for a Clinical Trial. In: Supino, P., Borer, J. (eds) Principles of Research Methodology. Springer, New York, NY. https://doi.org/10.1007/978-1-4614-3360-6_6

Download citation

  • DOI: https://doi.org/10.1007/978-1-4614-3360-6_6

  • Published:

  • Publisher Name: Springer, New York, NY

  • Print ISBN: 978-1-4614-3359-0

  • Online ISBN: 978-1-4614-3360-6

  • eBook Packages: MedicineMedicine (R0)

Publish with us

Policies and ethics

Search

Navigation