Medical Writing Patient-reported outcomes Medical Communications
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Volume 27, Issue 4 - Patient-reported outcomes

Medical Communications

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.

References

  1. Fiebig D. Back to the future…or the amazing lack of progress in effective document review. Med Writ. 2015;24(3):169–72.
  2. Bernhardt SA. Improving Document Review Practices in Pharmaceutical Companies. J Bus Tech Commun. 2003;17(4):439–43.
  3. 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.
  4. 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.
  5. CORE Reference: Clarity and Openness in Reporting (E3-based): Available from: https://www.corereference. org/media/1032/core-referencev1_ 0.pdf.
  6. 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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Articles

Patient reported outcomes
President's Message
EMWA News
Measuring health outcomes: The foundation of contemporary healthcare decision-making
Measuring quality of life – theoretical background
Quality of life measures – an overview
Publication planning and patient-reported outcomes: Demonstrating value in a multi-stakeholder era
Patient-reported outcome measure translation: An overview
Systematic hospital collection of patient-reported outcome data via patient apps
The PROMIS of electronic patient-reported outcomes
Interview with Professor Matthias Rose on developing patient-reported outcomes and the PROMIS initiative
The UK pharmaceutical industry braces for Brexit, be it mild, severe, or doomsday
Awareness of medical writing as a profession and its career prospects
Estimands – closing the gap between study design and analysis
Protecting the rights of clinical trial patients through disclosure: The significance of plain language
News from the EMA
Regulatory Matters & Regulatory Public Disclosure
Medical Communications
Medical Devices
Journal Watch
In the Bookstores
Good Writing Practice
Getting Your Foot In The Door
My First Medical Writing
Out on Our Own

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