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Scientific article
Open access
English

Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials

Published inClinical Infectious Diseases, vol. 72, no. 7, p. 1259-1264
Publication date2020
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.

Keywords
  • Contract research organizations
  • Multidrug-resistant bacteria
  • New drug approval
  • Phase 3 trials
  • Anti-Infective Agents/therapeutic use
  • Communicable Diseases/drug therapy
  • Humans
  • Randomized Controlled Trials as Topic
  • Research Personnel
Citation (ISO format)
PAUL, Mical et al. Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials. In: Clinical Infectious Diseases, 2020, vol. 72, n° 7, p. 1259–1264. doi: 10.1093/cid/ciaa930
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Identifiers
ISSN of the journal1058-4838
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Creation11/03/2020 5:37:00 PM
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