Patients & Clinical Research
Objectives of the group
The Group has set itself the goal of encouraging the involvement of patients and their associations in clinical research programs.
Operation
It meets approximately every 3 months to review its various actions. The actions are carried out by sub-groups and therefore discussed in quarterly plenary meetings led by Alain BALEYDIER.
Actions
- Constitution of the directory of Patient Associations that have agreed to collaborate with the members of AFCROs (36 associations). Finalize its online release;
- Development of a questionnaire « Feedback on the contribution of associations to research involving the human person (RIPH) ». The use of this questionnaire must now be promoted among associations, CROs, industrialists and authorities;
- Writing of an article « Patient Participation in Clinical Research: for early, sustainable and transparent participation ». (3 pages; being finalized). It will then be necessary to disseminate the article to patients, industrialists and authorities;
- Training of patients’ associations in clinical research using the half-day module developed by the group in coordination with France Assos Santé;
- Organization of breakfasts on themes related to the group’s objective.
Group Members
A working group initiated by AFCROs in 2016, it is currently made up of 22 members including representatives of patient associations, industrialists, a member of CPP and members of AFCROs.
It is moderated by Alain BALEYDIER – member of the CODIR of AFCROs
The associations: :
- Jean Marc Charrel – France Rein
- Laura Phirmis – Fédération des Diabétiques
- Marie-Laure Sorbier – AFPRAL
- Raphaël Darbon – France Vascularités
- Carole André – AFM-Téléthon
- Hervé Nabarette – AFM-Téléthon
- Annie Archer – Groupe AMyasthénie de l’AFM-Téléthon
- Marianne Rivière – LUPUS PLUS
- Danielle Vacher – ANDAR
- Karim Oulad Chrif – ANDAR
- Marielle Lelait – Genethon
- Irène Pico – AFPric
- Christine Gétin – HyperSupers TDAH France
- Laëtitia Domeninghetti – Les Feux Follets
- Abigail Thuayre – France Alzheimer
- Kévin Rabiant – France Alzheimer
Committee for the Protection of Individuals :
Marie-Amélie Eudeline – CPP Sud Est 4
Industrialists :
Sandrine Orabi – SANOFI PASTEUR
Marwan Sleiman – Actelion Pharmaceuticals France
Renaud Mougenot – Air Liquide
Juliette Longin – Merck
The members of AFCROs :
Hervé Servy – SANOIA – Animateur
Meryem Harrizi – Carenity
Jean-Christophe Didier – Medpace
Contact : groupe-prc@afcros.com
How to reach us?
The working group is collaborative in nature. It aims to include people and entities or diverse and varied structures that have in common the desire to develop and promote partnership in clinical research.
Three types of structures are present today and the process for joining us is adapted to each one.
There is no participation fee. This process was established by group members in May 2021. It may be revised.
Promoter :
- You are a drug or MD manufacturer or an academic promoter
- You must have prior experience as an RIPH study promoter or have a RIPH project=> please contact the group : groupe-prc@afcros.com
Professional | Clinical Research Society :
- ou must be a member of AFCROs
- You agree to regular participation
= & gt; use the Participation Request process (see below)
Patients Association | assimilated structure:
- In order to guarantee a fair treatment of requests, this channel is reserved for non-profit associations with an object relating to health.
- or individual if no association exists for their disease
- or other structure being analyzed on a case-by-case basis
= & gt; use the Participation Request process (see below)
Participation Request Process:
- step 1: express your motivated participation request to groupe-prc@afcros.com
- step 2: an exchange will be offered to you with 2 members of the working group to share your expectations and your possible experiences of involvement in clinical research.
- step 3: your request will be submitted to the working group which will be the decision-maker (refusal if at least 2 members have justified an unfavorable opinion, otherwise a favorable opinion).
Attractiveness
Acting with and with all stakeholders to make France an attractive country for Clinical Research
Medical devices
French expertise on the clinical evaluation of medical devices
Clinical Research Professions
Promote clinical research careers among students and professionals
Real world data
French expertise on real life primary and secondary data
AI & Clinical Research
Use of Artificial Intelligence to serve our CRO professions
Patients and Clinical Research
Patients at the heart of clinical research
Regulatory
single convention
Monitor the use of the single convention
Regulatory
CPP-ANSM
Follow the regulations relating to study authorization requests
Regulatory
CNIL-RGPD
Follow health data protection regulations
Human vigilance
To develop and share good practices for the professional achievement of Clinical Research staff
Decentralised clinical trials
Reflections on the creation of an agile and secure methodology for the development of decentralised clinical trials in France.