The workshop, entitled ‘Transatlantic collaboration on clinical trials related to antimicrobial resistance (AMR)’ was held in Stockholm, Sweden on 21-22 January 2016. The goal of the workshop was to identify barriers for the efficient conduct of high-quality global antibacterial clinical trials, and specifically to:
- share information on current existing initiatives for clinical trial networks for antimicrobial resistance, in order to learn from each other and avoid duplication of efforts;
- discuss challenges and opportunities to overcome barriers for the efficient conduct of high-quality global clinical trials;
- foster opportunities for collaboration between the different networks and initiatives in the EU, US, and Canada to facilitate clinical research in our fight against AMR;
- produce concrete deliverables and action points towards solutions and recommendations to overcome the barriers identified through better alignment of existing networks and resources.
The key conclusions and recommendations of the workshop, and an update on initial follow-up actions taken, can be found in the event report.
Since the workshop, there has been continuous exchange between existing US and EU networks for the conduct of clinical trials related to antimicrobial resistance, resulting in alignment between US and EU capabilities and an increase in sharing of experiences in conducting multidrug resistance trials. Specifically, a test case is ongoing on how alignment of US and EU clinical trial structures could help meet patient enrolment goals. Through IMI’s networks CLIN-NET and LAB-NET, established by the COMBACTE project under the ND4BB programme, suitable clinical sites are being identified to participate in one of the ongoing NIH/NIAID targeted clinical trials on multidrug resistance.
The discussions at the workshop also helped the participants to better understand the capabilities of existing networks to answer key questions and conduct different types of clinical trials with antibiotics, i.e. trials directed at multi-drug resistant MDR pathogens vs more standard registrational trials for new antibacterial drugs. This has catalysed further dialogue among the various stakeholders both in the US and in Europe on the need for facilitating the latter.
Finally, the workshop was instrumental in helping the participants to understand that there are multiple models for infrastructures to conduct clinical trials, both existing and contemplated, and it is important to differentiate and distinguish which model one has in mind.
Over 60 people attended the workshop, which was organised by IMI in collaboration with the National Institutes of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID), the European Commission (EC), the Joint Programming Initiative Antimicrobial Resistance (JPIAMR) and the IMI project COMBACTE. The participants included representatives of funding organisations/initiatives, large and small companies, academic researchers, regulators, and clinicians from both sides of the Atlantic.