Improving Data Quality and Reducing Site/Patient Burden in Remote Rare Disease Trials
Fully remote or hybrid administration of clinical outcome measures in rare disease trials is on the rise. This is because of the recognition that remote assessments reduce patient burden through efforts within the industry to increase enrollment of traditionally under-served populations. Further, many assessments in rare disease trials are complex, and remote/hybrid trials readily allow for the use of highly expert centralized raters to administer and score the scales, thereby improving data quality via a decrease in variance and an increase in reliability for data collected.
Bringing the Clinical Trial to the Patient in Preclinical Alzheimer’s Disease
With the first demonstration that anti-amyloid therapies can slow amyloid accumulation and reduce clinical disease progression in symptomatic Alzheimer’s disease, there is increasing focus on the extent to which disease modifying therapies, applied very early in AD, may delay symptom onset itself.
Cultural-Linguistic Considerations for Successful Cognitive Endpoint Assessment in International CNS Clinical Trials
Appropriate utilization of clinical and linguistic experts helps ensure high-quality data is gathered from cognitive assessments in global trials. In this webinar, Dr. Svenja Wacker will describe considerations for successful cognitive assessment in global trials and share how clinical trial teams can benefit from local expert clinicians supporting their CNS research.
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.
Leveraging Remote Assessments and Central Raters to Optimize Rare Disease Clinical Trials
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.
Implementing Decentralized Clinical Trials in CNS: Cognitive and Clinical 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.
Early Detection of Alzheimer’s Disease: Deficits in Learning Appear Before Memory Impairment
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.
Using Cognitive Assessment to Improve Decision Making in Oncology Clinical Trials
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.
Digital Technologies for Assessing Patient Functioning in Multiple Sclerosis Clinical Trials
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.
Improving Signal Detection in Rare Disease Clinical Trials
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.
A Better Way to Measure Cognitive Safety & Tolerability
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.
Remote Administration Considerations for Conventional and Computerized Clinical Outcome Assessments
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.
Covid-19: Considerations for Clinical Outcome Assessments in Clinical Trials
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.
