How Real World Data and Preparedness are Needed in Fight Against for AMR

Today marked the start of the 2-day World Anti-Microbial Resistance Congress 2021, which is being held in Washington, DC. The conference offered on-demand content to view important presentations.

Michael Craig, director, Antibiotic Resistance Coordination and Strategic Unit, National Centers for Emerging and Zoonotic Infectious Diseases, presented his session, Prioritizing Prevention: How We Get Ahead of the Global Threat for of AMR. Craig discussed the prevention lessons learned during the COVID-19 pandemic.

These included:

• Not treating our way out of a pandemic;
• We get what we pay for now. Specifically if we don’t invest in public health capacity and prevention we will not have these when we need them: early detection and containment; response capacity to stop transmission; infection control; and evidence based prevention interventions including vaccines and preventatives; and
• Preparedness is not exercises, tabletops and planning documents alone. No amount of hypothetical planning will prepare us for an unknown threat if we cannot address our localized outbreaks and known endemic threats.

Craig then posed the question, if we do not seriously invest in preventing known threats like antibiotic-resistant infections, should we be confident that we can adequately address new emerging threats?

He said the ability to prevent AMR infections is about preparedness. New and emerging threats happen regularly in AMR, and investing in AMR prevention tools provides resiliency. Staff and laboratory well trained to stop current outbreaks. These investments would keep us from dividing our attention when new threats emerge.

Najy Alsayed, MD, head of Disease Area, Infectious Diseases Menarini Group presented his session, The contribution of Real-World-Data in AMR: Which studies and why? Alsayed discussed examining real world data (RWD) and real world evidence (RWE).

For the former, RWD is an umbrella terms to describe :

1. Effects of disease: patient characteristics, clinical and economic outcomes, health related quality of life
2. Healthcare interventions (e.g. safety, effectiveness, resource use)
3. Primary research data: intervention use in routine clinical practice
4. Secondary research data: from routine practice collected data.

RWE is created through analysis of RWD.

Alsayed pointed out the FDA and EMA use RWD and RWE to monitor post market safety and adverse events to make informed regulatory decisions.

The paradox of AMR, explained Alsayed, was the rise of AMR and the increasingly thin new antibiotic availability. He pointed at that from 1983 to 1987 there were 16 new antibiotic agents and that from 2008 to 2012 there were only 2 new antbiotics.

He went on to say there were a number of reasons for this including suboptimal new antibiotic approval and poor patient access to antimicrobials.

Alsayed pointed to three areas where RWD contributions may improve access to new antimicrobials, including:

• Allowing rational use vs current rationed use
• Allowing targeted patient treatment approach
• Demonstrating new antimicrobials benefit to both patients and the healthcare system.