Dose Finding Extension News Today : Breaking News, Live Updates & Top Stories | Vimarsana

The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new items and 19 modified items) to early phase dose-finding trials with interim dose escalation or de-escalation strategies. Such trials generally focus on safety, tolerability, activity, and recommending dosing and scheduling regimens for further clinical development. These trials are often inadequately reported, hampering their informativeness and making evidence informed decisions difficult. The CONSORT-DEFINE guidance aims to develop an international, consensus driven guideline for reporting early phase dose-finding trials to promote transparency, completeness, reproducibility, and facilitate the interpretation of the results. The CONSORT-DEFINE guidance provides recommendations for essential items that should be reported in early phase dose-finding trials to promote gr ....

Glasgow City , United Kingdom , West Midlands , United Kingdom General , United States , Daiichi Sankyo , Janssen Clovis , Oxford Biotherapeutics , Lilly Incyte , Celgene Eisai , Sumitomo Dainippon Pharma , Genentech Roche , Bristol Myers Squibb , Astra Zeneca , Merck Serono , Sanofi Aventis , Cancer Research United Kingdom , International Delphi , United Kingdom Medical Research Council , United Kingdom Research , European Federation Of Pharmaceutical Industries , University Of Maastricht , University Of Birmingham , Takeda Pharmaceuticals , Imperial Biomedical Research Centre , Royal Marsden Institute Of Cancer Research ,