Perspective on adaptive designs: 4 years European Medicines Agency reflection paper, 1 year draft US FDA guidance – where are we now?

Autor:	Armin Koch, Frank Miller, Sue-Jane Wang, Martin Posch, Brenda Gaydos, Marc Vandemeulebroecke
Rok vydání:	2012
Předmět:	medicine.medical_specialty Reflection (computer programming) business.industry Adaptive design Agency (sociology) Perspective (graphical) Alternative medicine Medicine Guidance documents General Medicine Public relations business Panel discussion
Zdroj:	Clinical Investigation. 2:235-240
ISSN:	2041-6806 2041-6792
DOI:	10.4155/cli.12.5
Popis:	Adaptive clinical trials attract great attention from academia, industry and regulatory authorities. Both the European Medicines Agency and the US FDA have clarified their positions in recently issued (final or draft) guidance documents. With this background, current trends and issues were analyzed in a panel discussion at the International Society for Biopharmaceutical Statistics (ISBS) meeting in March 2011. In this article, members of the panel summarize their thoughts based on this discussion.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::b384d021fa1d556d2f23890ba4ac7462 https://doi.org/10.4155/cli.12.5 Zobrazit plný text záznamu