The reference for writing Clinical Study Report [Clarity and Openness in Reporting: E3-based (CORE)] and the guidance for writing Clinical Study Protocol – a new initiative of the European Medical Writers Association and the American Medical Writers Association_Part 2

medications-3Though the CORE (Clarity and Openness in Reporting: E3-based) Reference is planned to be available in the mid-2016, it is very likely that BWG review and analysis will be shared for review at the end of the first quarter of the 2015.

Industry professionals such as Drug Information Association (DIA), Medical Writing Community or the regulators including EMA, FDA or Health Canada state that there is a need for this type of reference, though it may happen that the CORE reference will not be officially impacting the ICH E3 Guidance.

There are five core members of the BWG: two freelance medical writers, one CSR expert, one biostatistician, and one freelance clinical pharmacologist, all of whom have broad experience in their respective fields.

It will take 4 steps to finalise the recommendations. Firstly, the existing guideline will be reviewed. Next, the results will be examined against the Good Clinical Practice, the needs of international medical writing community and industry trends. The third step will concentrate on consultations with stakeholders. Finally, the results of this industry-based review will be consolidated and integrated into one reference document.

Hopefully, in the middle of the next year we will all share one comprehensive resource, that in an accurate and professional way will lead us through the process of summarising, analysing and publishing results of clinical research.

The idea of developing a new guideline in a close collaboration with all relevant stakeholders, such as medical community, patient advocates, industry, and regulators is most likely to result in broad acceptance of the CORE Reference.

The EMWA initiative additionally includes the guidelines for preparing clinical study protocols. Appropriate understanding of the construction of both critical documents will definitely improve the cohesion of study projects. It will be easier to adapt and simply ‘feel’ the guideline which will clarify everyday problems, and answer ‘hanging questions’ that the whole world of clinical trials face in day to day practice.

References:

  1. http://www.amwa.org/Files/About%20Us/BudapestWorkingGroupPressRelease28Jan15.pdf
  2. http://www.emwa.org/EMWA/News_Items/EMWA-AMWA_have_partnered_to_develop_the_all-new_CORE_Reference.aspx
  3. Hamilton S., Seiler W., Gertel A. 2014. The EMWA Budapest Working Group: A 2-year collaboration to make recommendations for aligning the ICH E3 guideline with current practice and developing clinical study protocol guidance. Medical Writing.  23(4): 281-288.
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