Decentralized Clinical Trials Solutions

Scientific Consulting, Instrument Adaptation, Rater Training, Central Rating, and Digital Assessment.

The ability to create patient-centric, rapid-to-enroll clinical trials is more important now than ever; biopharma teams are adopting decentralized models to meet these needs. Cogstate is expertly positioned to support a full suite of decentralized clinical trial solutions.

Through our pharmaceutical and academic collaborations, we’ve tested thousands of individuals remotely including in safety studies, large online registries, global Phase II studies, and pivotal Phase III studies.

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Scientific & Operational Expertise Selecting and Adapting Instruments for Remote

Cogstate’s science and operations teams have experience in all variations of virtual assessment and can offer guidance and suggestions through every step of a trial. As leaders in cognitive testing, our team can help weigh the feasibility of adapting traditional and digital clinical outcome assessments (COA) into a remote format. Areas of consideration include test manipulatives, length and equivalency of assessments, permissions, method of administration, cultural-linguistic assessment nuances for translated scales, capture in EDC, and more.

Of the various types of COAs, direct-report (PRO, ObsRO), interview-based (ClinRO), and auditory-verbal tasks (PerfO) may all be highly amenable to remote assessment contexts. Cogstate’s team can talk through the viability of a scale for remote use and offer adaptation options where required.

Remote Administration of Conventional Clinical Outcome Assessment

Many paper-and-pencil cognitive assessments—in conventional or eCOA format—can still be viable to conduct remotely. Cogstate has worked on delivery of multiple COAs for ‘remote-supervised’ assessment and can share lessons learned and feasible adaptations to help your research progress. Scales delivered remotely include the Clinical Dementia Rating, MOCA, Vineland Scales, Clinical Global Impression Scale, and more.

Cogstate’s team includes a network of more than 175 clinicians and scientists who are highly trained in the areas of psychology, neuropsychology, psychiatry, and neurology. These professionals help sponsor teams collect high quality data in 40+ languages via central rating, central scoring, and rater training.

Central Rating

With Central Rating, cognitive and clinical outcome measures are administered by a focused, independent team of highly qualified raters via telehealth (video or phone). The entire cohort of Cogstate raters can be uniformly and regularly trained and calibrated to increase reliability, standardizations, and scoring accuracy. This approach also allows sites to have rapid access to experienced professionals and allows participants to be assessed from the comfort of their home, reducing the number of site visits–supporting faster and more diverse recruitment.

Whether your clinical trial is fully decentralized with all assessments administered remotely, or a hybrid scenario with both in-clinic and at-home activities, the central rating approach can be customized to meet the objectives and requirements of the protocol.

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Central Scoring

Scoring of many clinical outcome measures can be highly manual, complex, time intensive, and error prone. In a central scoring model, assessments are completed by site raters either in-clinic or via telephone or videoconference. Cogstate expert raters then score the assessments. Utilization of experts for centralized scoring (or score validation) can dramatically improve scoring accuracy and reduce variance, thus improving data quality.

Rater Training and Central Monitoring

Traditional rater training is often redundant and burdensome to sites and inefficient for clinical trial sponsors. Cogstate’s unique programs provide rater qualification, instruction, and management that prepare raters to administer scales to the highest standards in the timeliest way possible. Rater are trained remotely via our customized eLearning curriculum and for decentralized trials, training includes guidance on conducting assessments in remote settings.

Cogstate’s approach eliminates unnecessary training by providing fit-for purpose levels based on a raters’ previous experience. This minimizes rater certification burden and allows for expedited study start-up.

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Cogstate Self-Administered Digital Cognitive Assessments

Clinical trial teams need testing solutions they can rely on to be effective and equivalent when deployed outside of the clinical site. The Cogstate battery has been utilized for in-clinic, supervised settings, and remote settings where assessment may be supervised or unsupervised. The optimal approach depends on the nature of the patient population, the test paradigm, and the type of devices utilized.

Cogstate tests can be organized into batteries to match the patient population and research paradigm. Cogstate tests are rapid, reliable, simple, and sensitive. Each test has been shown to be valid for use in different cultures and language groups with comparative/normative data available for both clinical samples and healthy controls. Tests have been used in all phases of drug trials and maintain excellent reliability across repeated testing and cross-sectional research designs.

Cogstate digital assessments are ideal for remote administration:

  • Adapted for self-administration with online learning modules to train participants
  • Fully web-based and can be accessed via tablet or PC devices
  • Brief and repeatable assessments
  • Email reminders sent when participants need to take their next test, increasing patient engagement

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Regulatory Landscape

Cogstate is aware of and well-equipped to work within regulatory guidelines specific to decentralized clinical trials.

FDA 21 CFR Part 11

FDA Digital Health Technologies for Remote Data Acquisition Draft Guidance

General Data Protection Regulation (GDPR)

How can we help you optimize the measurement of brain health?

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