Investor2014 Thursday, 05/30/19 07:10:13 AM Re: Jonjones325 post# 194777 Post # of 232258 Multi-regional clinical trials and global drug development Quote:Abstract Drug development has been globalized, and multi-regional clinical trial (MRCT) for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH) has initiated the process for having a harmonized guidance document on MRCT. This document is likely to be issued in early 2017. Quote:BENEFITS MRCTs can expedite global clinical development and facilitate registration in all regions across the globe. The ultimate goal of MRCT is to bring new medicines to patients globally as fast as scientifically possible and reduce the drug lag. MRCT also helps in expansion of clinical research into developing countries bringing medical care options to subjects who otherwise may not have access to them. Investment in drug development increases potential benefits to local scientific and medical and paramedical professionals. It provides access to more advanced technologies and helps in the development of technical expertise. MRCT provides the sponsors access to otherwise untapped pools of patients, as well as early patient access to new medications. Not without issues, as the article describes, but given good results the approach Anavex is taking could get A2-73 to market in more regions quicker.