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Comparative Safety and Effectiveness of Newer Antimicrobials

NOMINATED TOPIC | June 3, 2022

1. What is the decision or change (e.g., clinical topic, practice guideline, system design, delivery of care) you are facing or struggling with where a summary of the evidence would be helpful?

Question: What is the comparative safety and effectiveness of newer antimicrobials (approved after FY 2012) compared to older antimicrobials (approved prior to 2010)? Does the safety or effectiveness vary by type of patient characteristics (e.g. age, sex, race, sicker patients such as those with kidney dysfunction)?

Population: Adults with infections studied in FDA pivotal trials or post-market trials; separately assess subgroups of patients who were infected with resistant pathogens and whether such patients were included/excluded as part of trial criteria.

Intervention and Comparator: Antimicrobials approved after FY 2012 and the comparison to older drugs in the trials (antimicrobials approved prior to 2010)

Outcomes: Response to treatment and how it is defined (definition of primary endpoints in trials, adverse effects, survival.)

2. Why are you struggling with this issue?

FDA standards for new antimicrobials were revised by statute in late FY 2012 in an effort to increase the availability of treatments for resistant bacteria, but there is uncertainty about the benefits or harms to patients that have resulted from those revised standards. Patients and their physicians need this information to make informed medical decisions.

3. What do you want to see changed? How will you know that your issue is improving or has been addressed?

Patients and their healthcare providers deserve clear scientific evidence about which newer and which older antimicrobials should be used for which patients under which circumstances. Labeling and Medication guides and clinical guidelines should reflect accurate scientific evidence, and transparency is needed for patients from demographic subgroups. We expect that this is not a large task because it is likely that there isn't a great deal of clinical trial data to review that compares older antimicrobials to newer ones.

4. When do you need the evidence report?

Mon, 10/30/2023

5. What will you do with the evidence report?

Our research center has an impressive track record of explaining complicated research findings to health professionals, patients and consumers, the media, and opinion leaders. We will ensure that the evidence report findings are widely reported and understood. Although I provided a date in #4, a thorough job is more important than a speedy result.

Optional Information About You

What is your role or perspective? Researcher and Administrator

If you are you making a suggestion on behalf of an organization, please state the name of the organization National Center for Health Research

May we contact you if we have questions about your nomination? Yes

Page last reviewed June 2022
Page originally created June 2022

Internet Citation: Comparative Safety and Effectiveness of Newer Antimicrobials. Content last reviewed June 2022. Effective Health Care Program, Agency for Healthcare Research and Quality, Rockville, MD.

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