Medical Writing Patient-reported outcomes Regulatory Matters & Regulatory Public Disclosure

Volume 27, Issue 4 - Patient-reported outcomes

Regulatory Matters & Regulatory Public Disclosure


A symbiotic relationship is an “intimate interaction between two or more species, which may or may not be beneficial to either”.1We can think of the bee and flower relationship. The flower provides the bee with nectar, while the bee provides pollination. Each entity or group in the relationship benefits from knowing or interacting with one another; they need each other to survive and prosper.


  1. Brenner L. What is a symbiotic relationship? [Internet]. Sciencing. 9 Aug 2018 [cited 4 Oct 2018]. Available from: Available from: 8794702.html.
  2. Sharma D, Lucier C, Molloy R. From solutions to symbiosis: blending with your customers. [Internet]. Strategy+Business. 9 Apr 2002 [cited 4 Oct 2018]. Available from: Available from: article/18411?gko=1539d.
  3. Smith I. The symbiotic relationship in business – complexity & simplicity. [Internet]. The Portfolio Partnership. 11 Dec 2012 [cited 4 Oct 2018]. Available from: Available from: the-symbiotic-relationship-in-businesscomplexity- simplicity/.
  4. Thomas Kathy B. Clinical trial disclosure and transparency: Regulation EU No. 536/2014. Public disclosure at the clinical trial level. Medical Writing 27(2):7–17, 2018 Available from: clinical-trial-disclosure-andtransparency/[ accessed 2018 September].
  5. Thomas KB. Clinical trial disclosure and transparency: ongoing developments on the need to disclose clinical data. In Medical writing the backbone of clinical development. International Clinical Trials. pp 63-70, 2017. Available from: http://edition.pagesuiteprofessional. a-ddd6-4705-bc9a-8af003f96adb [accessed 2018 September].
  6. Thomas KB. Clinical Trial Disclosure and Transparency: The Medical Writer’s Perspective; in Thomas KB, Reeves A, (eds): EMWA Symposium. EMWA, 2014, pp 6–17. Available from: Transparency%20Symposium%20 Budapest%20Final.pdf [accessed 2018 September].



Patient reported outcomes
President's Message
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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