Abstract
There was a sense of disappointment that greater consensus was not achieved by the Food and Drug Administration/American Urological Association workshop. 1 Jarow J.P. Thompson I.M. Kluetz P.G. et al. Drug and device development for localized prostate cancer: report of a Food and Drug Administration/American Urological Association public workshop. Urology. 2014; 83: 975-979 Abstract Full Text Full Text PDF PubMed Scopus (7) Google Scholar Clinicians, researchers, patients, and industry were looking for direction and instead witnessed a missed opportunity. We would like to highlight some issues. Drug and Device Development for Localized Prostate Cancer: Report of a Food and Drug Administration/American Urological Association Public WorkshopUrologyVol. 83Issue 5PreviewSummary of the discussion at a public workshop cosponsored by the U.S. Food and Drug Administration (FDA) and the American Urological Association reviewing potential trial designs for product and device development for the treatment of localized prostate cancer. Product development for treatment of localized prostate cancer has been stymied by the impracticality of using overall survival as an endpoint in patients with localized disease and the lack of acceptable surrogate endpoints. A workshop evaluating potential trial designs for the development of therapies for localized prostate cancer was held in San Diego, CA, in May 2013. Full-Text PDF Reply by the AuthorsUrologyVol. 84Issue 3PreviewWe appreciate the comments put forth by the authors and agree that there remains a great need for improved risk stratification of men diagnosed with presumed localized prostate cancer. Multiparametric magnetic resonance imaging was discussed at the workshop held 1 year ago. The sentiment of the panel was that although promising, multiparametric magnetic resonance imaging had not yet been shown to be reliable and reproducible in multicenter trials. In regards to end points, the Food and Drug Administration has a statutory requirement to approve products that are safe and effective for their intended use. Full-Text PDF
Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
