A blog from the Centre for Research Ethics & Bioethics (CRB)

Month: September 2024

How do we create sustainable research and development of new antibiotics?

Antibiotic resistance is a growing global challenge, particularly for modern healthcare, which relies on antibiotics to prevent and treat infectious diseases. Multi-resistant bacteria are already present across the globe and without effective antibiotics, simple medical interventions will become risky in the future. Each year, several million deaths globally are associated with antibiotic resistance. With more and more drug-resistant microorganisms, one could expect an increase in research and development of new antibiotics or vaccines. However, in parallel with the growing global threat from antimicrobial resistance, or AMR as it is often called, the development rate of new antibiotics is instead decreasing. Reduced R&D also reduces the number of experts in the field, which in turn affects our society’s ability to develop new antibiotics.

Why is that so? One reason is that the return on investment is so low that many large pharmaceutical companies have scaled back or abandoned their development programs, resulting in a loss of expertise. The effort to slow down the development rate of antibiotic resistance requires us to save the most effective medicines for the most difficult cases, and this “stewardship” contributes to inhibiting the will to invest, as the companies are unable to count on any new “blockbuster” drugs.

The problem of access to effective treatment is global, and on September 26 this year, the UN General Assembly is organizing a high-level meeting on AMR. The political declaration published ahead of the meeting highlights, among other things, the need for mechanisms for funding research and development, the need for functioning collaborations between private and public actors, and the need for measures to deal with the growing lack of competence in the area.

However, the picture is not only dark. During the last decade, several investments have been made in collaborations to meet the challenges for research and development in the field. One such investment is the European AMR Accelerator program, running since 2019 with funding from the Innovative Medicines Initiative (IMI). The program consists of nine projects that bring different stakeholders together to collaborate on the development of new treatments, for example against multi-resistant tuberculosis.

In a short article recently published in Nature Reviews Drug Discovery, representatives of the program discuss some of the important values ​​and challenges associated with collaborations between academia and industry. Antibiotic development is expensive and many drug candidates are discontinued already in the early stages of development. By sharing risks and costs between several organizations, the AMR Accelerator has so far been able to contribute to the development of a large portfolio of different antibiotics. In addition, the nine projects have developed research infrastructures for, among other things, modelling, data management, and clinical studies that can benefit the entire AMR research community. Moreover, the critical mass that is generated when 98 organizations collaborate, can generate new ideas and synergies in the work against AMR.

There are also challenges. Among the challenges is balancing the perspectives and needs of different actors in the program, not least in the collaborations between academia and industry, where cooperation agreements and regular meetings have been needed to manage differences in culture and approach. The AMR Accelerator program has also served as neutral ground for competing companies, which have been able to can collaborate within the framework of the projects.

According to the authors, the biggest challenge remains: what happens after the projects end? The Innovative Medicines Initiative has invested €479 million in the program. The question now is how the nine projects and partners will find long-term sustainability for the assets and infrastructures they have put in place. Some form of continued funding is needed so that the resources created within the AMR Accelerator can be used in the next phase of the work, where the end goal is providing access to drugs that can treat antibiotic-resistant infections.

The article concludes with a call to governments, research funders, pharmaceutical companies and other actors to invest in research and development of new medicines and research to support the fight against antibiotic resistance. To ensure that we can benefit from investments such as the AMR Accelerator in the long term, regular funding calls are needed to maintain expertise, infrastructures, data and networks.

Read the highly topical article here: The AMR Accelerator: from individual organizations to efficient antibiotic partnerships.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Fernow J, Olliver M, Couet W, Lagrange S, Lamers MH, Olesen OF, Orrling K, Pieren M, Sloan DJ, Vaquero JJ, Miles TJ & Karlén A, The AMR Accelerator: from individual organizations to efficient antibiotic development partnerships, Nature Reviews Drug Discovery, first online 23 September, DOI: https://doi.org/10.1038/d41573-024-00138-9

This post in Swedish

Approaching future issues

Return of health data from clinical trials to the patients

During a clinical trial, large amounts of health data are generated that can be useful not only within the current study. If the trial data are made available for sharing, they can be reused within other research projects. Moreover, if the research participants’ individual health data are returned to them, this may benefit the patients in the study.

The opportunities to increase the usefulness of data from clinical trials in these two ways are not being exploited as well as today’s technology allows. The European project FACILITATE will therefore contribute to improved availability of data from clinical trials for other research purposes and strengthen the position of participating patients and their opportunity to gain access to their individual health data.

A policy brief article in Frontiers in Medicine presents the project’s work and recommendations regarding the position of patients in clinical studies and the possibility of communicating their health data back to them. The project develops an ethical framework that will put patients more at the center and increase their influence over the studies they participate in. For example, it tries to make it easier for patients to dynamically design and modify their consent, access information about the study and retrieve individual health data.

An extended number of ethical principles are identified within the project as essential for clinical trials. For example, one should not only respect the patients’ autonomy, but also strengthen their opportunities to make informed decisions about their own care on the basis of returned health data. Returned data must be judged to be of some kind of benefit to the individuals and the data must be communicated in such a way that they as effectively as possible strengthen the patients’ ability to make informed decisions about their care.

If you are interested in greater opportunities to use health data from clinical trials, mainly opportunities for the participating patients themselves, read the article here: Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants.

Pär Segerdahl

Written by…

Pär Segerdahl, Associate Professor at the Centre for Research Ethics & Bioethics and editor of the Ethics Blog.

Ciara Staunton, Johanna M. C. Blom and Deborah Mascalzoni on behalf of the IMI FACILITATE Consortium. Ethical framework for FACILITATE: a foundation for the return of clinical trial data to participants. Frontiers in Medicine, 17 July 2024. https://doi.org/10.3389/fmed.2024.1408600

This post in Swedish

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