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- W1977173657 abstract "The scope, size and regulatory sponsor requirements for Clinical Trials related to Medicinal Products have reached, over the past two decades, a degree of complexity making them increasingly difficult to implement by non-industrial sponsors. In recent years, however, these difficulties are being recognized, and various initiatives and guidelines to facilitate Investigator-Driven Clinical Trials indicate that the situation may be gradually changing. Novartis recognizes that scientifically rigorous Investigator-Initiated Trials with a sound medical rationale can provide essential contributions in furthering knowledge about diseases and their treatments. It therefore encourages implementation by the Healthcare Community of meaningful Clinical Research that adds to better understanding of medical needs and how to address them, with the ultimate purpose of optimizing patient care and treatment outcomes. In this presentation the concept of Investigator-Initiated Trials will be discussed from an industry perspective. The regulatory guidelines and Novartis processes for supporting such trials will be explained, using examples from the field of Ophthalmology, and the potential areas of interest in Retinal Vascular Diseases will be outlined." @default.
- W1977173657 created "2016-06-24" @default.
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- W1977173657 date "2012-08-06" @default.
- W1977173657 modified "2023-09-26" @default.
- W1977173657 title "Investigator-initiated trials: a corporate perspective" @default.
- W1977173657 doi "https://doi.org/10.1111/j.1755-3768.2012.2822.x" @default.
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