Dr. Kelly Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently a Principal Scientific Advisor at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.
Regulators and experts consider patient-reported outcomes (PROs) as the gold standard when assessing a patient’s subjective treatment experience. As such, ePROs can be the key to product differentiation for sponsors seeking to highlight their product’s ease of administration, tolerability, or compatibility in combination with other components of a treatment regimen.
A clinical trial population should mimic the patient population that will ultimately use the therapy that is being studied. Sounds logical, doesn’t it? Unfortunately, this has not always been the case and there have been negative consequences, such as instances where people with disabilities or of certain racial groups experienced adverse effects to approved drugs […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.