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Reuse of RWE data in Decentralized Clinical Trials - May 2023

Reuse of RWE data in Decentralized Clinical Trials

Decentralized clinical trials (DCTs) based exclusively on the reuse of secondary data coupled with the collection of primary data collection directly from patients (ePRO, and connected devices) have already taken place in the USA.
While totally decentralized and dematerialized studies are not yet possible in France, there are solutions to get closer to this goal while we wait for the regulations to change.
 
 
May 2023

Early acces pathway in France: all you want to know

Different pathways are dedicated to innovative drugs in France.  Early access authorization is enabling the early availability and reimbursement of a medicinal product indicated for a severe, rare or disabling disease, when conditions are met.
 
 
April 2023

Clinical Research in France - Key figures

France remains one of the European leaders in clinical research in 2022.

Despite a slight drop in research activity in 2022, France remains positioned as a leader in the initiation of clinical studies in Europe ahead of Spain and UK.  In terms of industrial trials, France is behind Spain and is almost on par with Germany.

March 2023
Decentralized clinical trials: from words to action

AFCROs whitepaper | Decentralized clinical trials: from words to action

Based on feedback, interviews with various stakeholders, and the views of
different actors in the care of patients, this white paper aims to determine the
optimal conditions for carrying out a hybrid decentralized clinical study in the
home.

25 October 2022

13th July 2022

AFCROs Guide to the appropriate use of data from the National Health Data System (SNDS)

The RWD working group of AFCROs, which brings together expert consultancy firms, presents the first practical guide integrating the whole circuit of data feedback in the SNDS as well as some recommendations on the most relevant way to use them. 

8th July 2021

Why France for clinical research

The association’s attractiveness group offers you a few key points on why you should choose France for your clinical trials

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