Using Data Analytics to Improve Quality in CNS Trials with Subjective Clinician-Rated Endpoints

Clinical Trials, Drug Discovery and Development, Life Sciences, Pharmaceutical,
  • Tuesday, June 05, 2018

On average, psychiatric drugs entering Phase I fail to achieve approval 94% of the time. Is poor data quality playing a role?

With a significant amount of data collection reliant on subjective, clinician-rated endpoints, optimizing quality can be tricky. Our expert speakers, Brandon Abbs, Associate Director, Clinical Science, ACADIA Pharmaceuticals Inc. and Alan Kott, Clinical Vice President and Practice Lead, Data Analytics, Bracket, will discuss the most common pitfalls and how to avoid them. This webinar will present real-world examples and case study data demonstrating how to identify rater-produced outliers and course-correct data quality issues mid-study.

You will learn how to:

  • Identify noisy data
  • Utilize technologies such as computerized data collection, audio and video surveillance, etc. to curtail data variability
  • Use data analytic approaches to optimize data quality

Speakers

Brandon Abbs, Associate Director, Clinical Science, ACADIA Pharmaceuticals Inc.

Dr. Abbs is currently a Clinical Scientist with ACADIA Pharmaceuticals, working on clinical trials for a new adjunctive antipsychotic treatment for individuals with schizophrenia. His clinical research training started with a PhD in Psychology from the University of Iowa, followed by a post-doctoral research fellowship in the Harvard Medical School Department of Psychiatry, where he studied cognition in schizophrenia. He was on clinical development teams at Alkermes, Tesaro, and Shire before joining ACADIA. In his role as Clinical Scientist, Dr. Abbs supports patient eligibility review, data monitoring, and Investigator/clinical rater training activities for ACADIA’s global Phase 2 and Phase 3 trials in schizophrenia.

Message Presenter

Alan Kott, Clinical Vice President and Practice Lead, 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 data analytics in multiple large schizophrenia studies. For the past seven 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, in Prague. Dr. Kott has a Medicinae Universae Doctor (MUDr) from Charles.

Message Presenter

Who Should Attend?

Professionals from pharmaceutical and CRO companies who are interested in CNS clinical trials, collection of clinician-rated data, and analytics that identify outliers and improve data quality.

We encourage executives, medics, contract managers, and clinical leads to attend.

What You Will Learn

You will learn how to:

  • Identify noisy data
  • Utilize technologies such as computerized data collection, audio and video surveillance, etc. to curtail data variability
  • Use data analytic approaches to optimize data quality

Xtalks Partner

Bracket

Bracket, with 9 offices and more than 700 employees worldwide, is a specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket at www.bracketglobal.com.

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