A Synthesis of Adaptive Designs in Clinical Trials Publication date: May 2016 / Download PDF Author: Roy Nitulescu, Agnihotram V Ramanakumar, and Vatché Bartekian Abstract Since 2006, when the adaptive design working group presented their work in Washington D.C., the literature on adaptive designs has greatly expanded. Some designs have emerged as inherently better suited to exploratory-phase trials, while others are more appropriate for confirmatory phases of drug development. This article pro...

Quality by Design and Risk-Based Monitoring Publication Date: February 2015 / Download PDF Authors: Ibtissem Triki and Vanessa Towers Brief Background Over the past decade, the clinical research industry’s standard to meet regulatory monitoring obligations has involved frequent and regular onsite monitoring visits with 100% source data verification (SDV). The belief that “more is better” continues even with new evidence that on-site monitoring practices do not necessarily guarantee patient...

Quality by Design in Clinical Research Publication date: May 2015 Originally published in Journal of Clinical Research Best Practices, Vol. 11, No. 5, May 2015Author: Vatche Bartekian “Quality is never an accident. It is always the result of high intention, sincere effort, intelligent direction, and skillful execution.” – William A. Foster In clinical research, “high quality” means that a study generates good, useful data, does not harm the study participants, and proceeds smoothly wi...

Clinical Trial Management: Houston, We Have a Problem Publication Date: April 2015 / Download as PDFAuthor: Reginald Exume In the management of clinical trials, whether they be local, international, multi-site, simple or complex, a variety of situations can (or should I say will) occur that will have you saying “Houston, we have a problem!” These complications may be related to an issue at the clinical site itself, within the CRO or at the Sponsor level, but could also be caused by the study...