Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials
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 b...
| Main Authors: | , , , , , , |
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| Format: | Journal article |
| Language: | English |
| Published: |
Oxford University Press
2020
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| _version_ | 1797068361398484992 |
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| author | Paul, M Harbarth, S Huttner, A Thwaites, GE Theuretzbacher, U Bonten, MJM Leibovici, L |
| author_facet | Paul, M Harbarth, S Huttner, A Thwaites, GE Theuretzbacher, U Bonten, MJM Leibovici, L |
| author_sort | Paul, M |
| collection | OXFORD |
| description | 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 personal 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.
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| first_indexed | 2024-03-06T22:09:40Z |
| format | Journal article |
| id | oxford-uuid:515ec33b-ed3d-433b-a534-cda1a0f97da4 |
| institution | University of Oxford |
| language | English |
| last_indexed | 2024-03-06T22:09:40Z |
| publishDate | 2020 |
| publisher | Oxford University Press |
| record_format | dspace |
| spelling | oxford-uuid:515ec33b-ed3d-433b-a534-cda1a0f97da42022-03-26T16:19:10ZInvestigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobialsJournal articlehttp://purl.org/coar/resource_type/c_dcae04bcuuid:515ec33b-ed3d-433b-a534-cda1a0f97da4EnglishSymplectic ElementsOxford University Press2020Paul, MHarbarth, SHuttner, AThwaites, GETheuretzbacher, UBonten, MJMLeibovici, LRandomized 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 personal 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. |
| spellingShingle | Paul, M Harbarth, S Huttner, A Thwaites, GE Theuretzbacher, U Bonten, MJM Leibovici, L Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials |
| title | Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials |
| title_full | Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials |
| title_fullStr | Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials |
| title_full_unstemmed | Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials |
| title_short | Investigator-initiated randomized controlled trials in infectious diseases: better value for money for registration trials of new antimicrobials |
| title_sort | investigator initiated randomized controlled trials in infectious diseases better value for money for registration trials of new antimicrobials |
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