JAAM

The Joint Access Advisory Mechanism (JAAM) is the entryway for the therapeutic European COVID-19 adaptive platform trials (APTs). It has recently expanded to include other respiratory syndromes. It is the single body, common to the EU-SolidAct, REMAP-CAP and ECRAID-Prime trials, that assesses requests from investigators or industry looking to test their compound in one or more of these trials.  

 

Composition

The JAAM is composed of a panel of seven renowned experts that are fully independent from the EU-funded APTs. They cover the following fields of expertise:

           - Pre-clinical research, animal models and basic virology

           - Clinical virology and infectious diseases

           - Immunology and inflammation

           - Pharmacology

           - Trial methodology

           - Health technology assessment

The coordinators of the EU RESPONSE and RECOVER projects, and the principal investigators of the EU-SolidAct, REMAP-CAP in Europe and ECRAID-Prime trials are observers of the JAAM.  

 

How it works 

The JAAM meets regularly, to assess requests for access according to the following criteria :

1- Public health interest;

2- Scientific, medical and ethical soundness;

3- Appropriate patient population, comparator and outcomes;

4- Promotion of coordination and optimal use of resources. 

Following its assessment, the JAAM emits recommendations to initiate negotiations for the trials, and the final decision on access is made by each trial’s coordinating bodies.

Download the JAAM brochure 

Process and timelines 

Any independent investigator or private company can request access to the EU APTs via the JAAM, in order to assess their repurposed or new investigational drug.

The applicant must first submit their proposal directly to the JAAM Secretariat at covid19trialseu@ecrin.org. Applications are intended to be prepared for a phase II trial with supporting documents from the earlier work. The secretariat is available to discuss the best timing for submission. Early contact with the secretariat is welcomed if you have a clear plan for drug development and you are willing to receive follow up emails. Applicants will be requested to cover all key characteristics of the compound and use the checklist to ensure all necessary elements are included in their submission. The JAAM Secretariat will then ensure all information provided by the applicant is complete (and may request additional information), and will consult the JAAM chair for eligibility of the compound.

After which, the Secretariat will organize a meeting of the JAAM, where the applicant will be able to present their proposal to the JAAM panel. Following the applicant's presentation, the JAAM will deliberate and emit a recommendation for the applicant to begin negotiations with one or more of the adaptive platform trials.

The JAAM Secretariat will inform the applicant of the recommendation within two working days of the JAAM meeting. The full cycle between the submission of a request and the notification of the applicant by the JAAM is 16 days.

Assessment process of the JAAM: