IPHARMA continue to hold a series of webinars in order to provide information to the vast media audience on various aspects of clinical trials conduct.
Adaptive design is an innovative approach that allows to conduct clinical trials more efficiently (with fewer patients, in shorter terms) or to increase the likelihood of demonstrating the effect of the drug. In studies with adaptation, the possibility of modifying a design or hypothesis is preliminary planned based on an intermediate analysis of the obtained data.
The aim of the new addendum is introducing improved and more effective approaches to design development, clinical trials, monitoring of their progress, documentation and reporting, and standards for the maintenance of electronic documentation and mandatory documents.
This guideline reveals general principles of the clinical study conduct, described in ICH E8, and provides recommendations for the extent of population exposure to assess clinical safety of the drugs intended for the long-term treatment of non-life-threatening diseases. ICH E1 is a tool for protecting a patient from serious and uncertain risks from a new (original) marketed product.
Efficacy and safety of novel russian non-nucleoside reverse transcriptase inhibitor elsulfavirine in combination with tenofovir/emtricitabine
The results of randomized multicenter partially blind comparative IPHARMA study of an elsulfavirine (ESV), non-nucleoside reverse transcriptase inhibitor (NNRTI) of novel generation has been published in the journal "Infectious diseases" 2017, v. 15, №3.
Webinar "Clinical trials in diabetes: approaches to drug development and methods for effectiveness and safety evaluating"
Currently diabetology is one of the most actively developing branches of medical science. Because there is high prevalence of diabetes among the world's population with serious problems and chronic complications. The development of new drugs for the treatment of diabetes needs in clinical trials. Studies in diabetology have a number of features, which we will discuss in our webinar.
A multicenter phase II study of the efficacy and safety of Quisinostat (an HDAC inhibitor) in combination with Paclitaxel and Carboplatin chemotherapy (CT) in patients (pts) with recurrent platinum resistant high grade serous epithelial ovarian, primarily peritoneal or fallopian tube carcinoma cancer (OC)
The results of IPHARMA clinical trial of Quisinostat were presented at the ASCO Annual Meeting 2017.