The mandatory template agreement for clinical trials (Convention Unique) governs clinical trials between sponsors and French research centres with the goals of simplifying and accelerating the process for launching clinical trials in France. Recent changes to the clinical trial agreement (CTA) templates, however, may not fully achieve these goals.

The current Convention Unique has been in effect since 2022, and on August 5, 2024, two updated templates for clinical trials have been released, following the adoption of an governmental Order of July 29, 2024. An updated Q&A was also released alongside these two new templates.

The new templates contain a number of significant changes and additions to the existing templates:

• New appendices: the template clauses to frame the provision of equipment or biological resources have been proposed in appendices 5 and 6, which were previously empty and left to be contractually negotiated by the parties, even though these complex subjects are essential to the concerned research. The updated clauses framing the provision of equipment or biological resources are now standardized, and therefore not contractually negotiable and will certainly be useful in many cases.

However, more complex projects may require additional agreements. For example,

• supply of equipment may have specificities regarding use, training, or maintenance or require particular supervision by the staff using it.

• as regards supply of biological resources, the templates seem to have a limited scope and show inconsistencies. For instance, the template focuses on biological resources used in France, and does not seem to address the export of such resources. Quality checks, safety requirements, labeling, and control during the various stages of sampling and transport are also not covered. Separate additional contract documentation will be needed to address these matters. Personal data is briefly dealt with by general and inconsistent provisions. For instance, the template suggests that the transfer of biological resources does not involve transfer of identifying data. Yet, most biological resources transferred for research purposes can be regarded as identifying data by data protection authorities. The further reference in the appendix to the obligation to comply with any necessary regulatory formalities, including compliance with a reference methodology or the Commission nationale de l'informatique et des libertés (CNIL) guidelines, is also confusing. Personal data processing in the context of collection and use of biological resources is complex. This should instead be included in an overall approach on protection of personal data in clinical research, considering the specificities and the nature of the experimental product.

As these appendices are considered optional by the FAQ, their content can be modified. This will lead to adjustments to these clauses. Maintaining such flexibility for the templates is welcome, but such modifications to the templates may add extra time to conclude the clinical trial agreements with the research centers, which is precisely what the models aim to limit.

• Additional cost items that impact pricing: the templates contains updated pricing terms: (i) pricing of existing research tasks have been increased; (ii) new pricing for additional tasks have been included - these new elements address the increased sophistication of research, and regulations applicable to some specific cases (e.g., consultation time to obtain informed consent from subjects in sensitive cases such as genetic research, reporting of side effects) and enter into more detail as regards the research lifecycle and various events that may occur during the trial (e.g., medical time required for research protocol’s modification, requests for new consent, intervention by a specialist physician, required medical time for training provided by the sponsor).

• European regulations: Updates and references have been added to the template to include the implementation of European regulations applicable to (i) clinical trials on medicinal products for human use and (ii) medical devices and in vitro diagnostic medical devices.

Next steps

These new template agreements aim at aligning with current clinical research practices in France and complete the previous templates. The new changes brought to the templates are consistent with the aim of accelerating contract negotiations with research centers. It remains to be seen if, in practice, these new versions catch up with the accelerated pace with which the industry is implementing increasingly sophisticated protocols and techniques.

In any event, any company seeking to deploy clinical trials in France must pay close attention to these new templates (the use of which is mandatory), and assess to what extent there may be any gaps with its (or its contract research organizations (CROs)) standard CTAs used for its trials.