Volume 29, Issue 1 - Visual Communications

Clinical trial design: Considerations for medical writers developing clinical trial protocols

Author: Tiago Silva

Abstract

Download the full article

References

1. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [Internet]. Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2). Current Step 4 version. 2016 Nov 9 [cited 2020 Jan 08]. Available from: https://database.ich.org/sites/default/files /E6_R2_Addendum.pdf.
2. TransCelerate Biopharma Inc. Clinical Content & Reuse. 2017 [cited 2020 Jan 08]. Available from: https://transceleratebiopharmainc.com/ initiatives/clinical-content-reuse/.
3. Chan A, Tetzlaff JM, Altman DG, et al. SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials. Ann Intern Med. 2013;158(3):200–7
4. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [Internet]. Structure and Content of Clinical Study Reports. Current Step 4 version. 1995 Nov 30 [cited 2020 Jan 08]. Available from: https://database.ich.org/sites/default/ files/E3_Guideline.pdf.
5. Al-Jundi A, Sakka S. Protocol Writing in Clinical Research. J Clin Diagn Res. 2016;10(11):ZE10–3.
6. Taylor R. Medical Writing: A Guide for Clinicians, Educators, and Researchers. 2nd ed. New York: Springer New York; 2011.
7. Bacchieri A, Cioppa GD. Fundamentals of Clinical Research: Bridging Medicine, Statistics and Operations. Milan: Springer; 2007.
8. Hulley SB, Cummings SR, Browner WS, Grady D, Newman TB. Designing clinical research. 4th ed. Philadelphia: Wolters Kluwer; 2013.
9. Patino CM, Ferreira JC. Inclusion and exclusion criteria in research studies: definitions and why they matter. J Bras Pneumol. 2018;44(2):84.
10. Spilker B. Guide to Clinical Trials. Philadelphia: Lippincott-Raven Press; 1991.
11. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [Internet]. Statistical Principles for Clinical Trials. E9. Current Step 4 version. 1998 Feb 5 [cited 2020 Jan 05]. Available from: https://database.ich.org/sites/default/ files/E9_Guideline.pdf.
12. International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use [Internet]. Estimands and sensitivity analysis in clinical trials. E9 (R1). Current Step 2 version. 2017 Jun 16 [cited 2020 Jan 05]. Available from: https://database.ich.org/ sites/default/files/E9-R1_ Step4_ Guideline_2019_1203.pdf.
13. Bridge H, Schindler T. Estimands – closing the gap between study design and analysis. Med Writ. 2018;27(4):52–6.
14. Evans SR. Clinical trial structures. J Exp Stroke Transl Med. 2010;3(1):8-18.
15. Griffin JP, Posner J, Barker GR. The Textbook of Pharmaceutical Medicine. 7th ed Chichester: Wiley-Blackwell/BMJ Books; 2013.
16. Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011;4(1):8–11.
17. Lim CY, In J. Randomization in clinical studies. Korean J Anesthesiol. 2019;72(3): 221–32.
18. Brody T. Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines. Amsterdam: Academic Press; 2011.
19. Food and Drug Administration [Internet]. Non Inferiority Clinical Trials to Establish Effectiveness – Guidance for Industry. 2016 Nov [cited 2020 Jan 05]. Available from: https://www.fda.gov/media/78504/ download.
20. Schumi J, Wittes JT. Through the looking glass: understanding non-inferiority. Trials. 2011;12:106.
21. Althunian TA, de Boer A, Klungel OH, Insani WN, Groenwold RHH. Methods of defining the non-inferiority margin in randomized, double-blind controlled trials: a systematic review. Trials. 2017;18(1):107.
22. Atkinson AJ, Huang SM, Lertora JJL, Markey SP. Principles of Clinical Pharmacology. Amsterdam/Boston: Academic Press; 2012.
23. European Medicines Agency [Internet]. Guideline on Investigation of Bio - equivalence. CPMP/EWP/QWP/1401/ 98 Rev. 1/ Corr. 2010 Jan 20 [cited 2020 Jan 05]. Available from: https://www.ema. europa.eu/en/ documents/scientificguideline/ guideline-investigationbioequivalence- rev1_en.pdf.
24. Nardini C. The ethics of clinical trials. Ecancermedicalscience. 2014;8:387.
25. Ayling K, Brierley S, Johnson B, Heller S, Eiser C. How standard is standard care? Exploring control group outcomes in behaviour change interventions for young people with type 1 diabetes. Psychol Health. 2015;30(1):85–103.
26. Jensen JS, Bielefeldt AØ, Hróbjartsson A. Active placebo control groups of pharma - cological interventions were rarely used but merited serious consideration: a methodo - logical overview. J Clin Epidemiol. 2017;87:35–46.