Volume 27, Issue 4 - Patient-reported outcomes
Medical Communications
Authors: Lisa Chamberlain James, Diana Radovan
Abstract
In a follow-up to the excellent article from Douglas Fiebig on how to use your review cycle effectively, this issue presents an extremely insightful article from Diana Radovan on how to help reviewers to communicate better with writers. Diana has more than 10 years’ experience in clinical development and scientific research, including preparation of regulatory documents and scientific publications. She has worked on both the client and vendor sides of the equation and so offers us her unique perspective on the writer/reviewer relationship.
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References
- Fiebig D. Back to the future…or the amazing lack of progress in effective document review. Med Writ. 2015;24(3):169–72.
- Bernhardt SA. Improving Document Review Practices in Pharmaceutical Companies. J Bus Tech Commun. 2003;17(4):439–43.
- Cuppan GP and Bernhardt SA. Missed Opportunities in the Review and Revision of Clinical Study Reports. J Bus Tech Commun. 2012;26(2):131–70.
- ICH E3 Guideline: Structure and Content of Clinical Study Reports Available from: http://www.ich.org/products/guidelines/ efficacy/efficacy-single/article/structureand- content-of-clinical-study-reports.html.
- CORE Reference: Clarity and Openness in Reporting (E3-based): Available from: https://www.corereference. org/media/1032/core-referencev1_ 0.pdf.
- ICH M4E Guideline: Available from: http://www.ich.org/fileadmin/Public_Web _Site/ICH_Products/CTD/M4E_R2v Efficacy/M4E_R2_Step_4.pdf.
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