Utilizing Computerized Cognitive Testing in Clinical Research

The CDR System has been the industry standard for assessing cognitive function in worldwide clinical trials for over 30 years. Two recent publications highlight how the tool has been used in clinical trials, and how it may be possibly utilized in future programs.

The first is a publication of the largest normative database ever developed for an automated test system. These data further reinforce the widespread utility of the CDR System in clinical research, providing a valuable reference source to help interpret the extent to which compounds may impair or improve cognitive function. These data should be especially helpful for drug developers working with new compounds in drug classes where possible neuro-toxicity is an issue.

The Phase III study conducted in adolescents into the cognitive effects of a novel treatment for refractory epilepsy further attests to the suitability of the CDR System for use in pivotal trials in any clinical population. These research data lend important insight to both drug developers and clinicians working in this area. A system which can be used in the first-to-man administration of a compound through to the registration programmes is invaluable to developers of novel medicines, and this latest example further establishes the CDR System as the current gold standard for worldwide drug development of any compound which may influence cognitive function.

CDR 3

FULL CITATION: Cognitive effects of adjunctive perampanel for partial-onset seizures: A randomized trial.Epilepsia. 2016 Jan 1. doi: 10.1111/epi.13279.
JOURNAL: Epilepsia
ABSTRACT: http://www.ncbi.nlm.nih.gov/pubmed/26724782
AUTHORS: Meador KJ, Yang H, Piña-Garza JE, Laurenz A, Kumar, Wesnes KA
YEAR: 2016

FULL CITATION: Norms for healthy adults aged 18-87 years for the Cognitive Drug Research System: An automated set of tests of attention, information processing and memory for use in clinical trials.
J Psychopharmacol. 2016 Jan 11. pii: 0269881115625116.
JOURNAL: Psychopharmacology
ABSTRACT: http://jop.sagepub.com/content/early/2016/01/07/0269881115625116.abstract
AUTHORS: Wesnes KA, McNamara C, Annas P.
YEAR: 2016

Charitable Efforts Across Bracket

Around the world, Bracket employees have supported various charitable initiatives throughout 2015. Employees at Bracket believe in giving back to our local communities and collectively we have donated and volunteered countless hours for several charitable events.

Through company and employee donations, Bracket office locations have maximized charitable efforts by supporting the following charities:

Thank you ImageBracket in Langhorne, PA collected 100lbs of food during the 2015 holiday Food drive. The contribution was made to Preston and Steve WMMR Campout for Hunger, which directly benefited Philabundance. This food drive collected a total of 1,161,290lbs of food, which comes out to 580 tons!

 

The San Francisco, CA location supported California’s foster children by donating toys to Sleep Train.  This toy drive helps provide foster children with supplies, shoes, clothing, and toys throughout the year.

Adopt a family- christmasBracket headquarters in Wayne, PA supported charities throughout the year by participating in:

  • Cradles-2-Crayons
  • Stop Hunger Now
  • One Warm Coat
  • Bike to Shore
  • Adopt a Family Thanksgiving
  • Adopt a Family Christmas

Bracket international office in Reading, UK took part in Mencap, where Bracket employees volunteered their day to paint a day care center.  In addition, the UK office also held a coffee morning for the MacMillan Cancer Support Charity,  and on the 8th of December,  staff continued to volunteer their time for Reading Family Aid, where they helped pack and sort toys for distribution to families in need.

We at Bracket know our support is making a difference, and we are excited to see how we can help our communities throughout 2016!

 

Bracket Announces the Newest Release of Rater Station℠ 4.0, an Industry-Leading eCOA Solution

(San Francisco, CA) Bracket, a leading clinical trial specialty services provider, has released version 4.0 of Rater Station℠, an innovative Electronic Clinical Outcomes Assessment (eCOA) tool designed to improve performance and outcomes in clinical trials. The Rater Station℠ platform that has been used extensively in Central Nervous System clinical trials, and version 4.0 is currently being used in two clinical trials that are actively recruiting.

Bracket’s Rater Station℠, an enhanced type of electronic Clinician-Reported Outcome (eClinRO), uniquely features intelligent design that provides added clinical value and quality control. Rater Station℠ has been used in dozens of pivotal worldwide studies, and is a core component of Bracket’s eCOA platform.

“The Rater Station℠ intelligent question design improves data quality while reducing investigator and patient burden. This release incorporates the feedback of more than 20 stakeholders, and is our most usable and secure version yet,” stated David G. Daniel, MD, Chief Medical Officer for Bracket.

In addition to a completely re-designed user interface, this release incorporates several critical improvements which enable sites to conduct their clinical interviews more accurately. These improvements include:

  • Persistent Auto-Save, loss of power, user error, or system malfunction will never mean lost data.
  • Advanced authentication and user management features, allowing study sponsors more granular control of which site personnel can access data.
  • A new and improved Question Library, allows for advanced customization for each scale and questionnaire programmed into the platform.
  • Improved clinical edit checks, designed to reduce errors and minimize burdensome data corrections.
  • New workflow that streamlines subject visits for study personnel.

“The reliable application of outcome measures is crucial to conducting high quality trials. Innovative technology can help with this issue. However, it is crucial that when introducing new technology, we take care to make patient assessment easier for site staff. Technologies such as Rater Station℠ can help improve trial conduct and, through intuitive design, aid patient assessment” stated John Harrison, PhD, Associate Professor Alzheimer Center at the VU University Medical Center, Amsterdam, and a member of Bracket’s Scientific Advisory Board.

About Bracket

Bracket, with seven offices and more than 500 employees worldwide, is a specialty services provider dedicated to helping biopharmaceutical sponsors and contract research organizations increase the power of their clinical research data by leveraging core competencies in Science, Technology, and Service. Bracket eCOA™ is a flexible platform for electronic clinical outcomes assessments. Bracket RTSM™ is a best-in-breed, scalable and configurable clinical IRT solution for the life sciences industry. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs. Learn more about Bracket at https://www.bracketglobal.com/.