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

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...

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Bibliographic Details
Published in:Clinical infectious diseases 2021-04, Vol.72 (7), p.1259-1264
Main Authors: Paul, Mical, Harbarth, Stephan, Huttner, Angela, Thwaites, Guy E, Theuretzbacher, Ursula, Bonten, Marc J M, Leibovici, Leonard
Format: Article
Language:English
Subjects:
Anti-Infective Agents - therapeutic use
Communicable Diseases - drug therapy
Humans
Randomized Controlled Trials as Topic
Research Personnel
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Summary: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. Costs of investigator-initiated trials are lower than those of industry-sponsored trials. We present our viewpoint on the sources of these costs and compare trials’ aims and methods. We propose a greater role for academic clinical trials networks, especially for antibiotic development.
ISSN:1058-4838
1537-6591
DOI:10.1093/cid/ciaa930