Volume 27, Issue 2 - Public Disclosure

Lay titles for clinical trials: A balancing act

Authors: Thomas M. Schindler, Clive M. Brown, Leonie H. E. Leithold

Abstract

Download the full article

References

1. Schulz KF, Altman DG, Moher D, for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMC Medicine 2010;8:18.
2. World Medical Association General Assembly. 2013. Declaration of Helsinki. Ethical Principles for Medical Research Involving Human Subjects [cited 20 Mar 2018]. Available from: Available from: https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjects
3. Taichman DB, Sahni P, Pinborg A, Peiperl L, Laine C, James A, et al. Data sharing statements for clinical trials - a requirement of the International Committee of Medical Journal Editors. JAMA. 2017;317(24): 2491–2.
4. World Health Organization (WHO). International Clinical Trial Registry Platform Trial Registration Data Set (Version 1.3) [cited 20 Mar 2018]. Available from: Available from: http://www.who.int/ictrp/network/trds/en/
5. Public law: Food and Drug Administration Amendments Act of 2007. US Public Law 110-185. (2007, Sept 27); 21 USC 301.
6. ClinicalTrials.gov Protocol Registration Data Element Definitions for Inter ventional and Observational Studies (2017, June 29) [cited 20 Mar 2018]. Available from: https://prsinfo.clinicaltrials.gov/definitions.html
7. Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014.
8. National Institutes of Health, Department of Health and Human Services. Clinical Trials Registration and Results Information Submission; Final Rule (2016, Sept 21). 81 FR 64981; 42 CFR Part 11.
9. Grant MJ. What makes a good title? Health Info Libr J. 2013;30:259–260.
10. Schultz DM. Eloquent Science: A Practical Guide to Becoming a Better Writer, Speaker and Scientist. Chapter 3: Writing an Effective Title. 2nd ed. Boston (MA): American Meteorological Society; 2009.
11. Saenz C, Reveiz L, Tisdale JF. Public titles of clinical trials should have ethics review. J Clin Epidemiol. 2015;68:1105–1107.
12. ClinicalTrials.gov Review of Protocol Submissions [cited 20 Mar 2018]. Available from: Available from: https://prsinfo.clinicaltrials.gov/ProtocolDetailedReviewItems.pdf
13. Salita JT. Writing for lay audiences: A challenge for scientists. Med Writing. 2015;24(4):183–189.