Characteristics of Single Pivotal Trials Supporting Regulatory Approvals of Novel Non‐orphan, Non‐oncology Drugs in the European Union and United States from 2012−2016

• প্রধান লেখক: Anne Vinther Morant (লেখক), Vivien Jagalski (লেখক), Henrik Tang Vestergaard (লেখক)
• বিন্যাস: গ্রন্থ
• প্রকাশিত: Wiley, 2019-07-01T00:00:00Z.
• বিষয়গুলি: article
• অনলাইন ব্যবহার করুন: Connect to this object online.

For regulatory approval of a new medicine, the gold standard for demonstration of efficacy has traditionally been a minimum of two positive, adequate, and well‐controlled clinical trials. Nevertheless, drugs to treat cancer and rare diseases are usually approved based on a single and often uncontrol...