Call for clinical data sets from the studies of prevention or treatment of bacterial infections

Antimicrobial resistance (AMR) is an acute challenge for global public health, with an estimate of 4.95 million deaths worldwide associated with bacterial AMR in 2019 (Antimicrobial Resistance Collaborators, The Lancet, 2022). Developing new effective anti-bacterial products represents a huge challenge for R&D organizations.

COMBINE is part of the AMR Accelerator, an IMI programme to progress the development of novel medicines to treat or prevent AMR infections. On the scientific side, COMBINE aims to standardise preclinical infection models, to improve the translation from preclinical to clinical development, and to optimize clinical trial design and data analysis. To fulfil these objectives, COMBINE is looking for clinical data from medicines developed to prevent or treat infections.

OPEN CALL FOR DATA

COMBINE is seeking collaboration partners willing to share their data and protocols for the analysis and subsequent development of innovative trial methodologies. We are looking for individual-patient level clinical data to identify factors that predict outcome of the clinical trial or factors that hamper success but only become visible with aggregation of data from multiple trials. By making your data available to COMBINE, you are contributing to making the development of products against AMR infections more expedited and efficient in the future.

What are WE looking for?

We are looking for data from antibiotics, vaccines, monoclonal antibodies, and other approaches to treat or prevent AMR bacterial infections, and we are equally interested in both successful and failed programs.

We are specifically looking for clinical efficacy data at patient-level, e.g. PK/PD (when applicable), correlates of protection, dose-response data, time-to-event data (both primary and secondary study endpoints). Additional relevant data include information to study specific subpopulations (gender, age, comorbidities) as well as study meta-data (e.g. study protocol).

What pathogens are WE interested in?

ESKAPE pathogens (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Enterobacter)
Escherichia coli, ideally ESBL positive E. coli
Clostridioides difficile

What´s in it for YOU or your company?

Beyond the general goals of improving translation to the clinics and improved clinical trial designs, you might also find some direct benefits for your company:

GET AN EARLY PREVIEW OF THE RESULTS: As project contributor, you will get access to the results of the analyses before they are made public.
GET MORE OUT OF YOUR DATA: Should we identify new findings specifically from your data, we will engage with you. We may also consider running specific analyses on your data upon your request, if they are within the scope of COMBINE.
GET INVOLVED IN THE ANALYSIS: Do you have a research question you were never able to answer using your available resources? Let us know: maybe we can investigate it on your data.
IMPROVE YOUR OVERALL DATA MANAGEMENT PROCESS: We can provide hands-on training on FAIRification of data for SME and academia – a process that is now increasingly becoming a pre-requisite imposed by funding agencies for grant application.

What about safety and data protection?

The COMBINE researchers commit to the highest standards of data security and protection in order to preserve the rights of data providers and personal rights and interests of all study participants, in the case of sensitive clinical data. Contact AMR-data-technical.COMBINE@grit42.com for more details and technical questions on data protection and FAIRification.

Are YOU interested?

Then get in touch! For technical questions on data protection and FAIRification, as well as to initiate the data sharing process, please contact AMR-data-technical.COMBINE@grit42.com. For questions, ideas and suggestions regarding the data analysis, please contact IMI-COMBINE@pei.de.

Send your EOI to AMR-data-technical.COMBINE@grit42.com.

About COMBINE

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 853967. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and EFPIA companies’ in kind contribution.

https://www.imi.europa.eu/

About AMR Accelerator

The aim of the Antimicrobial Resistance (AMR) Accelerator Programme is to progress the development of new medicines to treat or even prevent resistant bacterial infections in Europe and worldwide. The programme comprises the following three pillars: a Capability Building Network, a Tuberculosis Drug Development Network, and the Portfolio Building Networks. The scope of the AMR Accelerator is broad; under one structure, it addresses many of the scientific challenges of AMR, and it supports the development of new ways to prevent and treat AMR. More broadly, the AMR Accelerator contributes to the European action plan on AMR.

For more information on the AMR Accelerator, please visit www.amr-accelerator.eu.

AMR Accelerator Participants

Disclaimer

This communication reflects the views of COMBINE and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.