Antimicrobial Resistance (AMR) is a widely recognised problem across the world. The World Health Organisation (WHO) has declared AMR as one of the top 10 global public health threats facing humanity. Currently drug resistant infections contribute to approximately 700,000 deaths globally each year. The WHO state:
“The clinical pipeline of new antimicrobials is dry. In 2019, WHO identified 32 antibiotics in clinical development that address the WHO list of priority pathogens, of which only six were classified as innovative.”
The initial licensing study for most new antibacterial agents is a complicated urinary tract infection (cUTI) study, these studies are relatively cheap, low risk and easy to enrol to. Other indications are skin and skin structure infections for Gram positive bacteria, and complicated intra-abdominal infections which are predominantly Gram negative. However these studies tend not to be carried out in the UK, and it is unclear as to why not.
Pneumonia trials, defined as community-acquired (CAP), hospital-acquired (HAP) or ventilated hospital-acquired (VAP), are sought after by the pharmaceutical companies, however these studies are relatively risky, difficult and expensive to conduct. These infections are seen to have more inherent resistance, and more pharmacokinetic (PK) variability; it is considered to be harder to identify these patients and enrol them to trials.
In order to support more AMR research in the UK we need to:
- Better our understanding of existing drugs for commonly encountered diseases in the NHS.
- Explore pathways and infrastructure to develop new antibiotics in the UK.
During the COVID-19 pandemic, multiple key national Urgent Public Health platform studies were delivered by the NIHR. These multi-arm adaptive study design trials enabled researchers to evaluate multiple treatments at once against the best standard NHS care available to rapidly provide crucial evidence regarding therapies and interventions urgently needed for the COVID-19 crisis. The success of the platform studies has shown that the UK has the capability to deliver innovative adaptive trials in the NHS and other settings.
Working with key AMR stakeholders, the NIHR Clinical Research Network Infection National Specialty Group is undertaking an NIHR strategic project to assess the applicability of a platform study approach for AMR in the UK, including defining the structure and mechanism of platform studies for different interventions and settings.
It is anticipated that the strategic project will enable the set up and delivery of platform design studies in AMR, which will not only revolutionise the way studies are delivered and coordinated across the Infection specialty, but will also highlight the benefits and improve engagement with life sciences companies.
Marking World Antimicrobial Awareness Week - 18-24 November
Listen to our podcast with Professor AndyUstianowski and Professor William Hope, Joint National Sepcialty Leads for NIHR CRN Infection, as they share a conversation about the challenges faced in combating the global AMR threat. They also discuss how collaboration and clinical research are critical tools in the fight of this world-wide issue.
The podcast covers how NIHR plans to play its part by establishing innovative platform trials, which will help to accelerate research into drug resistance and development of new antimicrobial agents. This approach, tried and tested in the COVID-19 pandemic, will create new opportunities for academic researchers and the life science industry to work smarter, faster and more collaboratively.