Medical Writing Regulatory Writing Basics Good clinical practice (GCP): A universal call for ethics in biomedical research

Volume 23, Issue 2 - Regulatory Writing Basics

Good clinical practice (GCP): A universal call for ethics in biomedical research

Abstract

Today, the principles of good clinical practice (GCP) form such an integral part of the development of new medicines that they could easily be taken for granted. Yet, the road to a universal code of ethics in human experimentation is paved with tragedies which have only gradually led to tightened rules on human experimentation. Awareness of the historical roots of GCP helps explain that GCP, rather than representing a seemingly endless series of regulations, finally provides an international ethical and scientific quality standard designed to protect the rights and safety of individuals consenting to participate in clinical trials and to ensure the integrity and credibility of clinical research data. For medical writers, familiarity with the principles of GCP, which in the European Union are now a legal obligation, is an essential prerequisite for providing documentation in compliance with the ethical and scientific principles of GCP: not only are medical writers expected to frame clinical research into a language that enables independent assessors to evaluate the methodological validity of a study and the safety and efficacy of a given drug, they also compose documents that may be instrumental in assuring the rights and safety of clinical trial participants.

Download the full article

References

  1. Vollmann J, Winau R. Informed consent in human experimentation before the Nuremberg code. BMJ 1996;313:1445–7.
  2. Grodin MA. Historical origins of the Nuremberg Code. In: Annas GJ, Grodin MA editors. The Nazi doctors and the Nuremberg Code: human rights in human experimentation. Oxford, UK: Oxford University Press; 1992. p. 121–44.
  3. United States Holocaust Memorial Museum, Washington, DC [updated 2013 Jun 10; cited 2014 Feb 11]. Available from: http://www.ushmm.org/wlc/en/article.php?ModuleId=10005168
  4. Office for Human Research Protections (OHRP). The Nuremberg Code. In: Trials of war criminals before the Nuremberg military tribunals under Control Council Law No. 10. Washington, DC: Government Printing Office, 1949, vol. 2, p. 181–2 [cited 2014 Feb 11]. Available from: http://www.hhs.gov/ohrp/archive/nurcode.html
  5. World Medical Association. History [cited 2014 Feb 11]. Available from: http://www.wma.net/en/60about/70history/index.html
  6. The Thalidomide Trust. The Story of Thalidomide [cited 2014 Feb 8]. Available from: http://www.thalidomidetrust.org/story
  7. Bren L. Frances Oldham Kelsey: FDA medical reviewer leaves her mark on history. FDA Consumer Magazine March–April 2001 [cited 2014 Feb 9]. Available from: http://permanent.access.gpo.gov/lps1609/www.fda.gov/fdac/features/2001/201_kelsey.html
  8. Florence L. Is thalidomice to blame? Lancet 1960;31:1954.
  9. Kalte F. Der Spiegel 1961;50:p89 [cited 10 Feb 2014]. Available from: http://www.spiegel.de/spiegel/print/d-32576654.html
  10. Verband Forschender Arzneimittelhersteller (vfa). Aus der Contergan-Katastrophe gelernt [published 2007 Nov 2; cited 2014 Feb 9]. Available from: http://www.vfa.de/de/arzneimittel-forschung/artikel-arzneimittel-forschung/teratogenitaet.html
  11. World Medical Association. WMA Declaration of Helsinki – Ethical Principles for Medical Research Involving Human Subjects [cited 2014 Feb 11]. Available from: http://www.wma.net/en/30publications/10policies/b3/
  12. World Health Organization. Handbook for good clinical research practice (GCP). Guidance for Implementation, 2002.
  13. World Health Organization. Guidelines for good clinical practice (GCP) for trials on pharmaceutical products. WHO Technical Report Series 1995;850.
  14. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Efficacy Guidelines. Good Clinical Practice E6 [cited 2014 Feb 10]. Available from: http://www.ich.org/products/guidelines/efficacy/article/efficacy-guidelines.html
  15. European Commission. Medical Devices – Clinical Investigation and Evaluation, International standard EN ISO 14155:2011 [cited 2014 Feb 11]. Available from: http://ec.europa.eu/health/medical-devices/dialogue-parties/working-groups/cie_wg_index_en.htm
  16. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) [cited 2014 Feb 11]. Available from: http://www.ich.org/
  17. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). Process of Harmonisation [cited 2014 Feb 11]. Available from: http://www.ich.org/about/process-of-harmonisation/formalproc.html
  18. Poolman RW, Hanson B, Marti RK, Bhandari M. Conducting a clinical study: a guide for good research practice. Indian J Orthop 2007;41:27–31.
  19. Joos S, Bleidorn J, Haasenritter J, Hummers-Pradier E, Peter-Klimm F, Gagyor I, et al. Ein Leitfaden zur Planung Nichtmedikamentöser klinischer Studien in der Primärversorgung unter Berücksichtigung der Kriterien der Guten Klinischen Praxis (GCP) [Manual for the design of non-drug trials in primary care, taking account of Good Clinical Practice (GCP) criteria] Zeitschrift für Evidenz. Fortbild Qualitätssich Gesundheitswesen 2013;107:87–92
  20. Claudon M, Dietrich CF, Choi BI, Cosgrove DO, Kudo M, Nolsoe CP, et al. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) in the liver – update 2012. Ultraschall Med 2013;34:11–29.
  21. European Commission. Medicinal Product for Human Use – Revision of the Clinical Trials Directive [cited 2014 Feb 12]. Available from: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd
  22. European Commission. Medicinal Product for Human Use – Revision of the Clinical Trials Directive. Proposal for a Regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC [cited 2014 Feb 12]. Available from: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd

Search

Articles

Regulatory writing basics
Message from the President
A guide to pre-approval regulatory documents
Effective authoring of clinical study reports: A companion guide
The clinical study protocol and medical writing: A good fit?
The Investigator's Brochure: A multidisciplinary document
An overview of the Common Technical Document (CTD) regulatory dossier
Good clinical practice (GCP): A universal call for ethics in biomedical research
Adverse event reporting: A brief overview of MedDRA
The approval process of medicines in Europe
Recommended procedures for retracting articles: Inadequate and patchily applied? Analysis of a recent article in PLoS One
The needs assessment in continuing medical education
Origin and development of English for Medical Purposes. Part II: Research on spoken medical English
Did minor flaws in a new drug reveal major flaws in company publication practices?
What every medical writer needs to know
Profile: An interview with Laura McMahon on the role of clinical research coordinators in Italy
In the Bookstores
Journal Watch: Dedicated medical writing rotation for pharmacists, publication of drug industry funded research, and evidence-based medicine for clinical decision making
Regulatory Writing: The essence of regulatory writing as defined by its jargon
Medical Communication
News from the EMA
English Grammar and Style: Points of view
The Webscout
Gained in Translation: Science at the multilingual crossroads
Out On Our Own
The Light Stuff

Links

The Write Stuff Archive Contact Instructions for Authors Article Template (Word) Journal Policies

Editoral Board

Editor-in-Chief

Raquel Billiones

Co-Editors

Evguenia Alechine

Jonathan Pitt

Managing Editor

Victoria White

Associate Editors

Anuradha Alahari

Jennifer Bell

Nicole Bezuidenhout

Claire Chang

Barbara Grossman

Sarah Milner

John Plant

Sampoorna Rappaz

Amy Whereat

Section Editors

Daniela Kamir

AI/Automation

Jennifer Bell

Biotechnology

Nicole Bezuidenhout 

Digital Communication

Somsuvro Basu

EMWA News 

Ana Sofia Correia 

Gained in Translation

Ivana Turek

Getting Your Foot in the Door

Wendy Kingdom / Amy Whereat

Good Writing Practice

Alison McIntosh 

In the Bookstores

Maria Kołtowska-Häggström

Lingua Franca and Beyond

Maddy Dyer

Publications

Lisa Chamberlain-James

Medical Communications/Writing for Patients

Payal Bhatia

Medical Devices

Evguenia Alechine

My First Medical Writing

Anuradha Alahari

News from the EMA

Adriana Rocha

Freelancing

Tiziana von Bruchhausen

Pharmacovigilance

Clare ChangZuo Yen Lee 

Regulatory Matters

Sam Hamilton

Regulatory Public Disclosure

Claire Gudex

Teaching Medical Writing

Louisa Ludwig-Begall / Sarah Kabani

The Crofter: Sustainable Communications

Louisa Marcombes

Veterinary Writing

Editors Emeritus

Elise Langdon-Neuner

Phil Leventhal

Layout Designer

Chris Monk