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

• Үндсэн зохиолчид: Anne Vinther Morant (Зохиогч), Vivien Jagalski (Зохиогч), Henrik Tang Vestergaard (Зохиогч)
• Формат: Ном
• Хэвлэсэн: Wiley, 2019-07-01T00:00:00Z.
• Нөхцлүүд: article
• Онлайн хандалт: 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...