Bracket Among the First Providers to Initiate BYOD ePRO Clinical Research Study in Japan

Wayne, Pa —Bracket, a leading clinical trial technology and specialty services provider, today announced the launch of a new Bring Your Own Device (BYOD) electronic patient-reported outcome (ePRO) study in Japan.  This study highlights the importance of BYOD use in clinical studies as an integral component of electronic clinical outcomes assessments (eCOA). Bracket is among the first to utilize BYOD in a randomized clinical trial in Japan.

The use of BYOD in clinical research is the next crucial stage in continuing to embrace the technology that has fundamentally improved the way studies are conducted. BYOD adoption is slowly gaining momentum, but the many ways it has enhanced the effectiveness of clinical research serve as an argument for why mobile support should become an essential element of other eCOA platforms.

Bracket’s own next-generation platform, Bracket eCOA™, integrates with several devices to support ePRO, eClinRO and eObsRO use, supplementing a BYOD approach. Allowing patients to collect and report data in a central location through easy-to-use mobile applications increases patient engagement and improves data quality.

“eCOA is an extremely important research tool and the increasing adoption of BYOD is highly beneficial for the industry on a global scale,” said Jeff Kinell, CEO at Bracket.

Bracket Patient Diary is a native app that allows patients in clinical trials to use their own smartphones to complete questionnaires about their symptoms, medication use, and quality of life. Bracket Patient Diary has been in use in clinical trials since 2014 and is available for Android and iOS.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and 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 SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.

Using eCOA to Assist with the MDS-UPDRS

By Adam Butler, Sr. Vice President, Strategic Development

Bracket announced this week that we are beginning work on new, electronic versions of the MDS-UPDRS and UDysRS for use in clinical trials. Developing eCOA versions of these scales, like all other clinical outcomes, will help to make research more efficient. But there are some components of these scales that are especially important to consider.

Endpoint Reliability

An important part of the work Bracket does with clinical outcomes is not only developing the tools that allow for better reporting and collection of data at the sites, but in doing the quality assurance work once the data has been submitted. Tracking and analyzing the integrity of the data submitted, and ensuring that clinicians are following scoring conventions, protocol standards, and monitoring for potential data variances.

Scoring Calculation Example from the MDS-UPDRS

With an outcome like the MDS-UPDRS, when the data is collected using Bracket’s Rater Station, careful timestamping can record the time for administration of individual sub tasks, for example, and ensure that they are being administered in accordance with the protocol, or track for significant outliers in administration times for individual patients or trial sties.

In addition, Bracket has shown in the past that a potential source of site variability can be a confounding of the Left and Right symptom scores in the Motor Examination portion. Collecting these scores using eCOA allows for an efficient QA check to ensure that these are being reported consistently.

Prompted Interviews

An important element of Bracket’s Rater Station is our use of a “Prompted Interview,” which allows for specific prompts and questions to be given to a rater during administration of a scale. Our intelligent scale approach allows for these prompts to be automated. In Part 1A of the MDS-UPDRS, for example, uses a “Stem and Probe” approach to clarify symptom severity. These probes can be programmed into the Rater Station, giving the clinician additional support during the clinical interview to ensure the scores are recorded accurately.

Scoring Automation

Some elements of the MDS-UPDRS require the clinician to do some simple math to determine an item score. While these calculations are relatively straight-forward, they can be a source of variance if not checked carefully. When administering and collecting the MDS-UPDRS electronically, these tasks are automated.

Stem and Probe Example from the MDS-UPDRS

 

Improving Data Quality

Combining well-design eCOA tools with proven Quality Assurance measures is one way to help improve data quality in clinical trials. Hopefully the implementation of these important scales from MDS can be useful in furthering clinical research for these diseases.

 

 

Read our press release on MDS-UPDRS here.  Please contact us if you would like additional information.

Bracket to Develop Electronic Versions of MDS-UPDRS and UDysRS for Parkinson’s Disease Trial Assessments

Wayne, PA., — Bracket, a leading clinical trial technology and specialty services provider, today announced an agreement with the International Parkinson and Movement Disorder Society (MDS), to develop electronic versions of the MDS-Unified Parkinson’s disease Rating Scale (MDS-UPDRS) and the Unified Dyskinesia Rating Scale (UDysRS). The migration of these complex scales to an electronic clinical outcome assessment (eCOA) format aims to improve trial conduct and data quality for Parkinson’s disease (PD) studies.

The increasing prominence of PD, a progressive disorder of the nervous system that affects movement, drove MDS to prioritize the update of its scales. Today more than 10 million people worldwide are living with the condition, and each year 60,000 people are newly diagnosed in the United States alone.

Bracket has extensive experience working with paper-and-pencil clinical outcomes in Parkinson’s disease and other movement disorders. Bracket is creating eCOA versions of the MDS-UPDRS and UDysRS to support efforts to improve data quality in these studies. Both scales require careful clinical interviews of patients, and by migrating these instruments from paper records to eCOA platforms, investigators and pharmaceutical sponsors will be equipped with a more effective method for using these outcomes in clinical trials.

“Clinical trials in Parkinson’s disease and other movement disorders are extremely complex and have a high failure rate,” said Jeff Kinell, CEO of Bracket. “Fortunately, digitization in clinical trials is improving results, as the logic of eCOA streamlines scoring protocols and compliance. We’re proud to partner with MDS to advance PD trials and help address the growing prevalence of the disease at the ground level.”

The UPDRS was developed in the 1980s and is the most widely used rating scale for PD in clinical trials. The revision, known as the MDS-UPDRS, was released in 2008 and measures mentation, behavior and mood, activities of daily living and motor functions. The UDysRS evaluates involuntary movements associated with treated PD, measuring on-dyskinesia, off-dystonia, impairment and disability.

The MDS-UPDRS and UDysRS scales are prime candidates for digitization as eCOA will streamline specific trial protocols, including the addition of time stamps associated with administration to ensure scales are administered appropriately. Additionally, eCOA will simplify calculations on how much time subjects report experiencing dyskinesia, dystonia and an “off” state.

About Bracket
Bracket, with nine offices and more than 700 employees worldwide, is a clinical trial technology and 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 SmartSupplies™ is a proven platform for improving a clinical supply chain. Bracket Rater Training and Quality Assurance improve outcomes through customized training and quality assurance programs.