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A look at clinical trial design for new antimicrobials for the adult population

Matteo Bassetti1,2, Daniele Roberto Giacobbe1,2, Maddalena Peghin3

  • 1Clinica Malattie Infettive, Ospedale Policlinico San Martino - IRCCS, Genoa, Italy.

Expert Review of Clinical Pharmacology
|October 15, 2019
PubMed

Insights

Antimicrobial resistance is a major global health threat. This review examines clinical trial designs for new antibiotics targeting multidrug-resistant organisms (MDROs), emphasizing collaboration for future drug development.

Area of Science:

  • Pharmacology and Infectious Diseases
  • Clinical Trial Design
  • Antimicrobial Resistance

Background:

  • Antimicrobial resistance (AMR) significantly threatens global public health, increasing infection treatment failure, morbidity, and mortality.
  • Multidrug-resistant organisms (MDROs) are a growing concern, necessitating the development of novel antimicrobial agents.
  • Effective treatment of MDRO infections is becoming increasingly challenging due to limited therapeutic options.

Purpose of the Study:

  • To review the advantages and disadvantages of classical and novel clinical trial designs for evaluating new antibiotics against MDROs.
  • To highlight the importance of innovative trial designs in addressing the challenges of developing anti-MDRO agents.
  • To emphasize the need for continued collaboration among regulatory agencies, academia, and industry.

Main Methods:

  • An inductive literature search was performed using keywords related to antimicrobial resistance, MDROs, and clinical trial designs.
  • The review synthesizes information on established and emerging methodologies for clinical trials.
  • Expert opinion is incorporated to provide insights into current challenges and future directions.

Main Results:

  • Recent advancements include the approval of novel anti-MDRO agents and promising compounds in late-stage development.
  • Classical trial designs may not always be optimal for evaluating novel agents against MDROs.
  • Innovative and non-conventional trial designs are gaining importance but require careful consideration and refinement.

Conclusions:

  • Continued cooperation between regulatory bodies, researchers, and industry is crucial for advancing anti-MDRO drug development.
  • Refining acceptable evidence levels through innovative trial designs is essential to ensure future availability of effective treatments.
  • Failure to adapt trial strategies risks perpetuating the unmet need for effective anti-MDRO therapies.
Keywords:
AMRMDRORCTantibioticsantimicrobialsnon-inferioritysuperioritytrial design

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