Investigator-initiated Randomized Controlled Trials in Infectious Diseases: Better Value for Money for Registration Trials of New Antimicrobials

Mical Paul, Stephan Harbarth, Angela Huttner, Guy E. Thwaites, Ursula Theuretzbacher, Marc J.M. Bonten, Leonard Leibovici

Research output: Contribution to journalReview articlepeer-review

Abstract

Randomized controlled trials (RCTs) conducted by the industry are expensive, especially trials conducted for registration of new drugs for multidrug-resistant (MDR) bacteria. Lower-cost investigator-initiated trials have recently been successful in recruiting patients with severe infections caused by MDR bacteria. In this viewpoint, we contrast the aims, methods, and resulting costs of industry-led and investigator-initiated trials and ask whether contemporary registration trial costs are justified. Contract research organizations, delivering and monitoring industry-sponsored trials at a significant cost, have little incentive to make trials more efficient or less expensive. The value of universal monitoring of all trial data is questionable. We propose that clinical trial networks play a more influential role in RCT design and planning, lead adaptive risk-based trial monitoring, and work with the industry to maximize efficient recruitment and lower costs in registration trials for the approval of new antimicrobials.

Original languageEnglish
Pages (from-to)1259-1264
Number of pages6
JournalClinical Infectious Diseases
Volume72
Issue number7
DOIs
StatePublished - 1 Apr 2021

Keywords

  • contract research organizations
  • multidrug-resistant bacteria
  • new drug approval
  • phase 3 trials

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