Non-commercial sponsors as the ultimate outsider. Response to Manfrin et al., 2025.

Non-commercial sponsors as the ultimate outsider. Response to Manfrin et al., 2025. | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 7 May 2025 V1 Latest version Share on Non-commercial sponsors as the ultimate outsider. Response to Manfrin et al., 2025. Author : Mohammed Zubair [email protected] Authors Info & Affiliations https://doi.org/10.22541/au.174662125.54121680/v1 177 views 125 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract Early phase trials, including phase II trials, play a direct role in the UK’s ambitions to lead in life sciences innovation, as outlined in its commitment to fast and efficient clinical research environments (Life Sciences Vision, UK Government, 2021). The analysis by Manfrin and colleagues of clinical trial submissions (Manfrin et al., 2025), clearly highlights the domination of commercial sponsors when it comes to early phase ATMPs (92.8% of submissions). Why is this? It is clear that commercial sponsors have and continue to be positioned as central stakeholders (Lord O’shaughnessy, 2025), (the data supports this, commercial sponsors represented 85.1% of the total submissions) and in turn justifies their significant integration into the UK government and regulatory infrastructures that shape the clinical trial landscape. Non-commercial sponsors are now firmly placed on the periphery, yet despite this they demonstrate remarkable resilience by submitting the greater number of phase II trials (37.3 v 26.6%). Their ability to conduct complex trials in these conditions is a remarkable achievement, underscoring both the importance and the potential of non-commercial research. Ultimately, a more inclusive and equitable regulatory system is needed—one that recognises and supports the efforts of non-commercial sponsors, enabling them to continue their vital contributions to the UK’s clinical research ecosystem, rather than keeping them on the outside. Mohammed Zubair, Ph. D Sponsor Representative The University of Manchester Supplementary Material File (letter to the editor br j pharmacology.docx) Download 18.19 KB Information & Authors Information Version history V1 Version 1 07 May 2025 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords pharmacokinetics stem cell therapy translational pharmacology Authors Affiliations Mohammed Zubair [email protected] The University of Manchester View all articles by this author Metrics & Citations Metrics Article Usage 177 views 125 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Mohammed Zubair. Non-commercial sponsors as the ultimate outsider. Response to Manfrin et al., 2025.. Authorea . 07 May 2025. DOI: https://doi.org/10.22541/au.174662125.54121680/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. 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