A public clinical trial institutions would stimulate development of antibiotics more effectively than programs involving for profit CROs according to new research.
The study by researchers from the London School of Hygiene and Tropical Medicine, the UK Centre for Ecology & Hydrology and University College Dublin was looking at ways of stimulating the development of novel antibiotics.
The challenge, according to the authors, is that for the pharmaceutical industry developing antibiotics makes little economic sense for a variety of reasons, one of which is the reliance on for profit clinical research organizations (CRO).
“Current clinical trial networks often rely on a commercial clinical research organization taking on risk and outlaying money with the hope of recouping investments once the network is running.
“The relatively small size of clinical research organizations and low proportion of revenue coming from antibiotics pose an inherent hurdle for attracting investment in antibiotic trials.”
Competition between CROs is another hurdle.
Global public network
The researchers wrote that “there is little synergy between different for-profit trial networks in the form of data sharing or shared infrastructure use, which adds to R&D costs.
“The need for financial returns can make developers focus investments on trials and licensing applications for the most lucrative drug applications and markets.”
To address this the authors suggested publicly funded clinical research centers should replace for-profit CROs in antibiotic development programs.
Under the plan a global public infrastructure of institutes would be tasked with conducting all trial stages up to market authorization, including small-scale compound production.
The network would also take responsibility for negotiating licensing deals for production and distribution according to the authors, who said that using public purchasing agreements or subscription models would ensure commercially viable production at equitable prices.
“Our proposed mission-oriented network of public institutes would address the clinical trial and manufacturing bottleneck by bridging the so-called valley of death of clinical trials for new antimicrobials.
They added that under the plan “Intellectual property for successful compounds would rest with the NIM [Networked Institute Model] as the market authorization holder in return for royalties as well as academic credit, or as a result of patent buyouts from academic institutions and small-size and medium-sized enterprises.”
The authors also suggested COVID-19 has “reshaped the willingness of states to consider public, non-profit solutions for health problems.”
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