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Published on: March 12, 2016
[Pioneering trials in ophthalmology-From clinical trials to guideline treatment]
Immanuel Philipp Seitz1,2, Melanie Ziegler3,4, Nadine Kahle3,4
1Universitäts-Augenklinik Tübingen, Tübingen, Deutschland. Immanuel.Seitz@med.uni-tuebingen.de.
Abstract:
The path from a clinical study to guideline-based treatment is often long and shaped by the interaction of numerous stakeholders. Scientific institutions, industrial and academic sponsors, national and international regulatory authorities and medical professional societies all contribute to translating scientific findings into evidence-based treatment recommendations. Clinical trials represent the central instrument for generating clinical evidence and form the foundation for regulatory decisions and for the development of modern treatment strategies. Using selected examples from ophthalmology this article illustrates how diverse the developmental pathways of new therapies can be, from the first clinical evidence to the integration into clinical guidelines. In addition, it highlights how clinical studies continue to support guideline development and enrich everyday clinical practice beyond the initial approval of new drugs. In this way, it becomes clear how clinical studies shape the entire translational process, from scientific innovation and regulatory evaluation to the establishment of treatment in guidelines and routine clinical care.
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