Glossary
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Discussion
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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 enterclinical 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 enterclinical 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
Plateforme sociétale genotoul http://societal.genotoul.fr/
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research ethics http://www.rd-alliance.org
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