Cultural-Linguistic Considerations for Successful Cognitive Endpoint Assessment in International CNS Clinical Trials
Cognitive assessment is a powerful tool to illuminate the effects of investigational therapies in CNS diseases. Tests of cognitive functioning, however, are nuanced and complex, and require a high level of clinical skill as well as hands-on assessment experience to achieve proper administration. Deployment of cognitive tests in global clinical trials is further complicated by considerable cultural bias inherent in traditional cognitive assessment. Since cognitive scales are mostly developed for use in English-speaking, Western contexts, the use of translated tests with patients in other cultural-linguistic groups can be problematic.
CNS Safety of Drugs in Late Phase Clinical Trials: Using Cognitive Information in Discussions with Regulators
In clinical trials of new drugs that have direct or indirect effects on the central nervous system (CNS), regulatory and medical/scientific groups must be confident that application of the drug at its established clinical dose is associated with negative effects on brain function. Cognition is one important marker of CNS function. In late phase clinical trials, the nature and magnitude of changes in cognition can provide an accurate index of negative CNS effects of the new drugs being studied.
In this webinar, Dr. Pam Ventola will share common pitfalls and tips for success when adopting remote testing in rare disease trials. She will describe the types of assessments that can feasibly be conducted remotely and how to prepare site raters to successfully conduct remote assessments.
What was once a slow trend towards decentralized healthcare and clinical research has now undergone a major inflection point. Driven in part by challenges resulting from the COVID-19 pandemic, clinical research teams are now embracing more decentralized clinical trial (DCT) activities, progressing well beyond pandemic-related mitigation strategies.
Clinical Trials of Schizophrenia: Optimizing Patient Reported Outcomes and Performance Outcome Assessments
The majority of clinical outcome assessments (COAs) in schizophrenia trials are clinician reported outcome (ClinRO) assessments such as the PANSS and various forms of CGI and functional instruments which use information from clinical interviews with the patient and perhaps a caregiver. These COAs provide critical insights into clinical status, making use of the expertise and insight of psychiatrists and other healthcare professionals.
There is now conjecture that disease-modifying therapies for AD may be most effective in the preclinical stages of the illness and therefore drug development programs are focusing on this stage of the disease. The large effects of amyloid observed on learning paradigms over short time periods suggests they could be a useful cognitive challenge model for early phase studies seeking to understand the effects of drugs designed to improve cognition in AD.
Advances in treatments are substantially increasing survival rates in people with cancer. While indices of overall survival and progression-free survival are the most widely accepted clinical endpoints for determining the efficacy of new therapies in oncology, there is growing interest in patient-centered clinical outcome assessments (COAs) to determine the potential benefits and safety of new and existing treatments as well as their effects on level of overall function.
Substantial progress has been made in the development of disease modifying therapeutics for Multiple Sclerosis (MS) in recent years. The array of next-generation compounds for this complicated disease have made great strides in increasing the time between relapse and delaying disease progression.
High-quality data are critical when seeking to measure treatment outcomes, but this is especially challenging in rare disease trials where the stakes are high with complex assessments and a limited number of eligible participants. In this webinar, Dr. Pam Ventola will describe customized rater training approaches that meet sponsors’ needs but also are flexible and efficient so to be feasible for sites.
Learn how to leverage integrated digital cognitive assessments and patient reports for advanced insights, streamlined delivery and lower burden. Watch the webinar from ERT and Cogstate to learn the value of assessing cognitive safety and tolerability throughout the drug development process, key considerations for selecting and optimizing computerized cognitive assessments, and more.
As the COVID-19 pandemic spread, research teams worldwide quickly adapted study plans to safely continue research whenever possible. While some observational studies were put on hold entirely, other therapeutic trials were continued with many or all study activities occurring remotely.
Cogstate senior scientists came together (digitally) from three continents to discuss clinical outcome assessments in the COVID-19 era. We invite you to watch the video of their roundtable discussion.
Clinical Outcome Assessments in Preclinical Alzheimer’s Disease: Considerations for Global Clinical Trials
Clinical trials designed to study interventions at the preclinical AD stage are using fit-for-purpose clinical outcome assessments that have high validity and reliability for the detection of cognitive change at this early stage of the illness. This webinar outlines the application of several preclinical stage instruments for use in industry clinical trials.
Clinical trials in patients with rare disease present considerable challenges, as patients with these conditions are typically heterogeneous and many are quite impaired. In this webinar, Dr. Pamela Ventola describes important factors to consider when selecting cognitive and behavioral endpoints for these trials and shares strengths and application considerations for several key scales.
In clinical trials, changes in performance on cognitive tests can provide a sensitive index of the impact of a drug on the central nervous system. This webinar details how the detection of decline in specific aspects of cognition, or in cognition in general, is important for making decisions about target engagement, maximum tolerated dose and pharmacodynamic profile.