Risk-based monitoring of clinical trial data for aberrant rating patterns and patient selection anomalies can be paired with audio/video surveillance to cost effectively identify at-risk sites in global schizophrenia trials.
Risk-based monitoring may be most effective when paired with a toolbox of instruments designed to enhance data quality collection, such as prompted interviews, intelligent e-scale design, and e-workbooks.
The speakers will present data and lessons drawn from risk based monitoring of 12 global schizophrenia trials involving over 80,000 visits.
Alan Kott, MUDr, Senior Manager Data Analytics, Bracket
Dr. Kott is based in Bracket’s Prague office and until recently was Senior Clinical Manager for Europe. Having led the development of the Data Analytics Program for Bracket, he has overseen the design and reporting of this program in multiple large schizophrenia studies. For the past 7 years, he has also provided training to investigators as an Expert Trainer. Dr Kott has been responsible for the design and implementation of multiple in-study data quality programs and served as a Product Business Owner for Rater Reliability Statistical Measures Application. Prior to Bracket, Dr. Kott worked as a house officer in Psychiatry at General Teaching Hospital, Department of Psychiatry, and as an Assistant Professor at Charles University, 1st Medical Faculty, Department of Psychiatry, both in Prague, Czech Republic. Dr. Kott has a Medicinae Universae Doctor (MUDr.) from Charles University.
David G. Daniel, M.D., Senior Vice President and Chief Medical Officer, Bracket
David Daniel, MD provides overall scientific, clinical and strategic direction for Bracket’s Scientific Services. Dr. Daniel was the founder and President of Global Learning, LLC which was acquired by United BioSource Corporation in July 2006. Dr. Daniel has formerly served as Medical Director of the NIMH Neuroscience Center at Saint Elisabeths where he supervised all clinical research; Director of Clinical Trials for the Stanley Foundation and was a founding principal of Best Practice, LLC, a Bethesda Maryland based think tank.
Dr. Daniel has nearly 30 years experience supervising and training raters in psychiatric clinical trials in the US and globally. He has published numerous scientific articles involving clinical trials and investigations of the psychopathology, treatment and evaluation of schizophrenia . He has received patent protection for new treatment approaches in epilepsy, anxiety disorders and motor side effects of antipsychotic treatment.
Dr. Daniel graduated Phi Beta Kappa and Magna Cum Laude from Emory University and obtained his medical school and psychiatry post-graduate training at Vanderbilt University where he served as chief resident. He was a medical staff fellow and senior staff fellow within the intramural program of the National Institute of mental Health (DIRP, NIMH) for 5 years.
Who Should Attend?
Medical/clinical personnel, executives, contract managers and project managers for pharma/biotech companies and CROs
Site investigators and raters
Academic and other parties invested in clinical trial success
Bracket is a Specialty Services provider dedicated to helping Pharmaceutical sponsors and contract research organizations achieve greater certainty and accurate outcomes in their clinical trials by seamlessly leveraging science, technology and operational excellence.
We offer comprehensive Endpoint Reliability™ solutions that incorporate Blinded Data Analytics, Diagnostic Solutions, Electronic Scale Administration and Collection, Audio/Video Capture and Review (VERIFIED™), and our computer-based cognitive assessment system (CDR System™). Our Trial Enhancement services include Rater Training and Certification, Scale Management, and Site Selection. In addition to our scientific expertise, Bracket offers Randomization and Trial Supply Management (Bracket RTSM) and ePRO technologies.
With comprehensive service offerings for clinical trial accuracy all under one roof, Bracket is unlike any other organization. Now companies both small and large can rely on one provider for both strategic and technological support covering every detail of their clinical trials.