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#129791

Different definitions for the same term frequently occur across domains and across jurisdictions. In such cases, it is important to indicate which definition is being relied upon in the document without implying or making a recommendation that that definition is the better, more accurate, or preferred definition. When we are aware of multiple definitions for the same term, it would be useful to include these in the glossary. However, we should make it clear that (1) there is no attempt to necessarily include all, or even the most important alternative definitions; and, (2) the only purpose of the glossary is to clarify the intended meaning of terms that are used in the glossary.
Cheers,
Claire
Sent from my iPhone
On May 27, 2020, at 6:29 PM, cambonthomsen via RDA COVID19 Coordination wrote:

Hello Robyn (taking care of glossary) and all coordination group colleagues
We had a discussion in the clinical group about the glossary; we had concentrated on the terms to be defined so far; the remark is now about the definitions themselves; in many instances they are definitions taken from US sources and are not “consensus definitions”; for example for clinical trials, as remarked by European co-moderators in the clinical group, Sergio Bonini and Christian Ohmann, there is a “legal” definition at EU level that at the same time is more precise and broader (cover several kinds of trials) than that reported in the glossary for the moment. Being in agreement onthe list of terms to define is achieved, considering which definition(s) to choose is another task that would require probably more time.
In the legal-ethical group work on the glossary is planned for next week
At least, since it would be difficult to come to a consensus on all definitions, we would suggest an introductory sentence in the Glossary that makes clear that the Glossary is only aimed at helping the reader in understanding the meaning of terms used in the document, but does not represent a consensus of the WG on the best definition among the many used for several terms.
It is difficult to see the logic or process to choose definitions for the moment in one source or another; is there a rule, a hierarchy (for ex are they mainly legal definitions, international insitutions one, community validated; many are US oriented and do not correspond for example to European official definitions, some of them being defined in European law like clinical trial see below :
Currently in the glossary it is defined as “Another name for an interventional study” whereas the definition given in the EU Regulation on clinical trial is :
‘Clinical trial’ means a clinical study which fulfills any of the following conditions: (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice (of the Member State concerned); (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects. Clinical Trial Regulation N.536/2014
https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg
The regulation also includes other definitions for clinical studies.
Another example is Compassionate use : In the glossary it is defined as “A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial…”.
the European Medicine Agency defines it as follows : “
” Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.”
https://www.ema.europa.eu/en/human-regulatory/research-development/compa
So, how do we proceed? Thanks in advance for your views
Anne
——– Message transféré ——–
Sujet : RDA 5th Revision
Date : Wed, 27 May 2020 19:21:53 +0200
De : Sergio Bonini
Pour : Anne Cambon-Thomsen , Lin, Dawei (NIH/NIAID) [E] , ***@***.***-duesseldorf.de, Jackson-Dipina, Andrea (NIH/OD) [E]
Dear all,
I enclose for Dawei a revised list of resources. I have done my best to include, in the short time available, the most relevant resources selected by me and Christian for the two Google documents. Added resources are marked in red. The list should be completed by Imaging resources. Christian, please have a look if I forgot something (unfortunately I had to confine to the main link all ECRIN resources).
With reference to Glossary, Anne please find enclosed the definition of clinical trials in Europe, according to the recent regulation.
‘Clinical trial’ means a clinical study which fulfills any of the following conditions: (a) the assignment of the subject to a particular therapeutic strategy is decided in advance and does not fall within normal clinical practice of the Member State concerned; (b) the decision to prescribe the investigational medicinal products is taken together with the decision to include the subject in the clinical study; or (c) diagnostic or monitoring procedures in addition to normal clinical practice are applied to the subjects. Clinical Trial Regulation N.536/2014
https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/reg
The regulation also includes other definitions for clinical studies.
I had a look at the Glossary and I have some doubts also about some other definitions, as for instance :
Compassionate use. Defined as “A way to provide an investigational therapy to a patient who is not eligible to receive that therapy in a clinical trial…”.
The Ema gives a different definition ” Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.”
https://www.ema.europa.eu/en/human-regulatory/research-development/compa
Although there is a reference for each definition, most of them are US-oriented. Definitions are always a problem and may represent a reason for criticisms.
Since it would be difficult to come to a consensus on all definitions, I would suggest an introductory sentence in the Glossary that makes clear that the Glossary is only aimed at helping the reader in understanding the meaning of terms used in the document, but does not represent a consensus of the WG on the best definition among the many used for several terms.
Best
Sergio

Dr Anne Cambon-Thomsen
Directrice de recherche émérite au CNRS
UMR 1027, Inserm, Univ Toulouse III – Paul Sabatier http://www.u1027.inserm.fr
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