Protocol Concept

Overview

The ARLG seeks proposals for clinical studies that align with our scientific agenda. These may be randomized controlled trials, case-control studies or cohort studies that aim to prevent, diagnose, treat, or eradicate antibiotic-resistant bacterial pathogens.

An ideal proposal will be a study that 1) has the potential to transform medical practice and 2) is unlikely to happen without ARLG support.

Studies of pharmacokinetics, pharmacodynamics, or studies in selected populations (e.g., immunocompromised hosts, patients in long-term care settings, neonates, overweight or obese children) are encouraged. Applications that propose pre-clinical or non-clinical research, studies of non-bacterial pathogens, or research not directly related to antibiotic resistance will not be considered.

Intensive budget constraints require focused prioritization of topics and feasibility of applications.

Preliminary Review

Complete this survey to submit your protocol concept. Once your preliminary information is received, you will be contacted to complete a comprehensive application.

Application Components

The comprehensive proposal application will ask for the following information as applicable:

  • NIH Biosketch of proposing investigator
  • Study rationale
  • Hypothesis
  • Primary objective(s) and endpoint(s)
  • Study centers (proposed)
  • Study population
  • Study design
  • Intervention/treatment
  • Sample size estimate
  • Timeline and length of participant follow-up
  • New and/or unique assay
  • External support/collaboration/funding
  • Publication references
  • Estimated costs in $ (direct)

Proposals will be carefully reviewed by the applicable ARLG committee.

“When I started out in my career researching new diagnostic approaches for host-gene expression, I often encountered skepticism and received many negative responses from conventional funding sources. However, ARLG recognizes that we cannot continue with the same approach and expect a different solution.

Ephraim Tsalik, MD, PhD
Duke University Medical Center

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