临床试验设计中的关键问题(精神病学)
2013-08-01 MedSci MedSci原创
n general. To improve and validate a scale, or to develop a new one, is a daunting task that often exceeds the capabilities of the individual investigator. The pharmaceutical industry spon
n general. To improve and validate a scale, or to develop a new one, is a daunting task that often exceeds the capabilities of the individual investigator. The pharmaceutical industry sponsor of a new drug is similarly limited in ability to create a new outcome measure that might be more optimal for novel drugs. Data based on proven instruments are required in a New Drug Application (NDA). Outcome data derived from a new rating scale would be regarded as supplemental evidence only. The emphasis
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#精神病学#
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#关键问题#
76