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Klinik Araştırmalar Derneği Uzaktan Eğitim Programları
Hakkında Detaylı Bilgi İçin
According to a study published in JAMA, among the 222 novel drugs approved by FDA between 2001-2010 and followed to 2017, 71 (32%) of them had new safety issues. Biologics, psychiatric therapeutics, and accelerated and near–regulatory deadline approval had the largest number of new safety warnings.
FDA published an information sheet for Payment and Reimbursement to Research Subjects.
EORTC organised an Independent Data Monitoring (IDRW) Committee workshop in the EORTC Headquarters in Brussels. Dr. Hamdi Akan from Turkey was there.
One of the largest scientific database software that contains more than 27 million citations; PUBMED is facing funding problems.
FDA has launched a new pilot program that will evaluate whether disclosing certain information within clinical study reports (CSRs) following approval of a new drug application (NDA) enhances public access to drug approval information. A CSR is a portion of a drug file, related to a clinical trial, that includes summaries of the bottom-line information on the methods and results of a clinical trial.
Among new cancer drugs approved between 2003 and 2013, up to one in five have no benefit for the patient. Fewer than half (43%) of the cancer drugs evaluated were found to increase Overall Survival (OS) by at least 3 months. A further 11% of the 53 drugs evaluated increased OS by less than 3 months, while 15% had an indeterminate effect on OS. The remaining 16 (30%) cancer drugs did not demonstrate an increase in OS over alternative treatments,
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light -- more than double the previous year -- while the figure also rose in the European Union. World?s biggest drugmakers saw average returns on their research and development spending fall, reflecting more competitive pressures and the growing share of new products now coming from younger biotech companies.
Clinical Research Association wishes a new year full of happiness and peace..