On 18 April 2018, two orders further detailing the rules on non-interventional and low-interventional trials in France entered into force.
The first order replaces a May 2017 Order that established a list of interventions allowed in low-interventional trials (see our previous blog post, France further clarifies scope of clinical trial rules). Low-interventional trials are trials with minimal risks and constraints mainly taking into consideration the age and condition of the subject, its physical condition and possible pathology as well as the frequency and duration of the interventions.
The first order, in comparison with the 2017 Order:
- Adds certain criteria that must be considered when determining the level of risks and constraints, in particular gender, foreseeable known risks and the administered/used products.
- Allows research under the supervision of healthcare professionals other than doctors provided that the acts that are conducted do not require medical supervision.
- Includes a revised list (in the Annex) of permitted interventions, including some new interventions (such as eye swabbing), and excluding others (such as certain medical treatment techniques).
The second order establishes a list of acts and procedures allowed in non-interventional trials, which are trials that do not entail any risks or constraints taking into account the same criteria as mentioned in the first order. The list includes, among others, the minimal (supplementary) collection of human body samples (blood or effusions) in the context of general care for the purposes of the research; the collection of human body samples (for example, saliva, urine, sperm) through non-invasive means collected outside the general care setting; registries; superficial swabbing (skin, nose, ear canal and so on); as well as interviews, tests or surveys (under certain conditions).
Low-interventional and non-interventional trials only require a prior favourable opinion from an ethics committee, as opposed to interventional trials which also require prior authorisation from the French National Agency for Medicines and Health Products Safety.
A prior version of this post was originally published by the same authors in Practical Law – Life Sciences, April 2018 issue (Thomson Reuters).