Focus on Psychiatric Assessments and eCOA
As the number of clinical trials has increased over the years, so too has the difficulty in monitoring and maintaining reliable data collection.
Clinical trials often involve multiple sites, often in multiple countries, languages and cultures. Reliable data collection depends on consistency among and within the raters collecting data. Unreliable data can lead to costly and potentially catastrophic results. Use of eCOA and rater training for all raters, whether they are site staff or patients, involved in a clinical trial improves data validity and reliability.
In this webinar, we will discuss what rater training is and why it is so important. You will learn what the FDA and EMA have determined regarding rater training and electronic data capture. We will be focusing on the increased need for psychiatric assessments in clinical trials for indications involving non-psychiatric outcomes, as well as specific psychiatric primary outcomes.
You will learn how rater bias, rater errors, and rater variability impact the quality of clinical data.
Importantly, you will learn how rater training coupled with electronic clinical outcomes assessment (eCOA) addresses many of the problems that plague clinical trials.
Because of the increase in the use of psychiatric assessments in clinical trials, more people without psychiatric experience are administering these assessments and many assessments rely on self-administration by research subjects, which makes rater training even more critical. Furthermore, it is just as important that raters experienced in psychiatric assessments be trained, as differences in assessment techniques introduces significant variability into data.
Unreliable data play a major role in clinical trial failure. Rater training and eCOA reduce poor data quality, improves inter-rater and intra-rater reliability, and reduce sample size while improving power to detect true effects. Join us in learning how to improve the quality of your clinical trials through rater training and eCOA.
Presented by
Nadeeka Dias, PhD,
Clinical Science Advisor
Dr. Dias is a Clinical Neuroscientist with over 7 years of research experience in addiction, psychiatry, and neuropharmacology as well as proficiency in the administration and scoring of psychological/CNS assessments. She completed her Postdoctoral Fellowship at Harvard Medical School/McLean Hospital and is highly skilled in working with psychiatric patients, particularly with depression, suicidal ideation and behavior, and addictive behaviors. As a science advisor, she provides scientific guidance on trial design and strategy, outcomes services, custom rater training consulting and development, and data analysis.
Rinah Yamamoto, PhD,
Clinical Science Advisor
Dr. Yamamoto is an experimental psychologist, with more than 17 years of experience in research. Her clinical areas of expertise include bipolar and unipolar depression, PTSD, OCD, and anxiety disorders, substance use disorders, incentive salience and interactions of nutrition and behaviour. She spent 9 years in the research and development of a novel low field electromagnetic treatment for bipolar and unipolar depression and other mood and anxiety disorders.
