Current Data Quality Monitoring Techniques Used in Central Nervous System (CNS) Clinical Trials

A recent paper published in Innovations in Clinical Neuroscience examined the issues surrounding the growing use of data quality monitoring in CNS clinical trials. Drs. David Daniel and Gary Sachs from Bracket contributed to this broad examination of the challenges and benefits of implementing this monitoring.

Executive_Summary_Fig16_J-F_2016The paper summarizes the results of the CNS Summit Data Quality Monitoring Workgroup analysis of current data quality monitoring techniques used in central nervous system (CNS) clinical trials. Based on audience polls conducted at the CNS Summit 2014, the panel determined that current techniques used to monitor data and quality in clinical trials are broad, uncontrolled, and lack independent verification. The majority of those polled endorse the value of monitoring data.

In a pre-competitive session among pharmaceutical companies, clinical service companies, and clinical trial sites, there was an overall strong consensus that data quality monitoring and remediation has large positive effects on signal detection in CNS trials.

The authors also examined how this data quality monitoring will evolve in the future. Increased utilization of biomarkers and genotypic and phenotypic patient characterizations will increasingly be used as patient selection and outcomes measures, but will require careful validation against current measures.

Although, there were a number of suggested new approaches, the creation of data banks of rater experience, credentials, and performance was agreed upon as high priority achievable pre-competitive objectives. Bracket has been a leader in this area, both through our own extensive proprietary database of investigator and rater experience in clinical trials, but through our support of the CNS Summit Global Rater Certificate Database.

Read the CNS Summit Data Quality Monitoring article here.

FULL CITATION: Data Quality Monitoring in Clinical Trials: Has It Been Worth It? An Evaluation and Prediction of the Future by All Stakeholders. Clinical Neuroscience. 2016 Feb 1.
JOURNAL: Innov Clin Neurosci. 2016;13(1–2):27–33
AUTHORS: David Daniel, MD; Amir Kalali, MD; Mark West; David Walling, PhD; Dana Hilt, MD; Nina Engelhardt, PhD; Larry Alphs, MD, PhD; Antony Loebel, MD; Kim Vanover, PhD; Sarah Atkinson, MD; Mark Opler, PhD, MPH; Gary Sachs, MD; Kari Nations, PhD; and Chris Brady, PsyD
YEAR: 2016

Bracket Announces New Patient Engagement Tools for eCOA Products

Wayne, PABracket, a leading clinical trial specialty services provider, announced platform updates to Bracket eCOATM and Bracket RTSMTM to include native support for SMS messaging with patients and other stakeholders in clinical research programs. This important update expands the medication compliance and adherence functionality across Bracket’s eClinical portfolio, and provides an effective solution for supporting patients participating in clinical trials.

“Patient communication tools are an essential component of effective patient engagement programs, and these updates reinforce our commitment to improving the patient experience in research programs through progressive methods offered by healthcare IT,” said Jeff Kinell, Chief Executive Officer for Bracket.

There is increasing evidence that text messaging is an effective and scalable tool for improving medication adherence amongst patients. Historically, interventions targeting medication adherence involved multimodal, resource intensive combinations that may not be feasible in clinical practice. Contrarily, text messaging offers confidential and unobtrusive support, instantaneous relay of information and boundless reach.  A study review in the February issue of JAMA Internal Medicine reported:

  • A 50 percent increase in adherence rates when text messaging was utilized; sms screenshot 2
  • High acceptance and satisfaction levels among most participants; and
  • Text messaging support as a valuable reminder with ease of use.

“Medication adherence is a critical variable in clinical trial success. Introducing a simple and effective communication tool like SMS could robustly improve compliance to medication regimens and a broad range of clinical trial procedures,” stated Dr. David Daniel, Chief Medical Officer of Bracket.

In addition to direct-to-patient communication, the mobile text messaging platform can be leveraged to issue alerts to clinical trial sites, study sponsors, and CROs who are working with Bracket’s RTSM and eCOA tools.

Bracket launched the initial SMS platform in 2015, and will continue to integrate patient engagement tools across the product line through a series of product releases and integrations in 2016.

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.

Bracket Finalist for CARE Awards: Best Patient-Focused Technological Development

Web_CAREAwards_stacked_4cBracket is proud to announce that we have been selected as a finalist for the Clinical and Research Excellence (CARE) Awards. The award ceremony will take place in Boston at the State Room on April 27, 2016.  The CARE Awards will display the wealth of innovation, dedication and hard work that pharmaceutical and biotech industries have demonstrated throughout 2015.

Bracket have been selected as a finalist in the ‘Best Patient- Focused Technological Development’ category, which acknowledges Brackets Intelligent Clinical Interviews for Alzheimer’s Disease.

mmse one question screenshot
Cognitive testing questions include intelligent, automated scoring.

Bracket has been working to improve outcomes in Alzheimer’s research for more than 10 years. Historically, the most effective intervention to improve outcome measurement was limited to enhanced training and intensive data analytics. However, as electronic source collection has become more prevalent, Bracket developed a proprietary Electronic Clinical Outcome Assessment (eCOA) platform that is designed to improve both the clinician and patient experience when evaluating treatment efficacy in a randomized trial. This technology has been used in numerous clinical trials, and in data presented last year, it was shown to significantly improve data quality in Phase 2 and 3 clinical trials.

More information on our eCOA platform is available here.



Bracket Presented at the 5th Biennial Schizophrenia International Research Society Conference

Dr. David Daniel presented new research at the 5th Biennial Schizophrenia International Research Society Conference on 2-6 April 2016 in Florence, Italy at the Firenze Fiera Congress Center.  This year’s conference focused on new drug development and the status of cutting edge basic and translational research in the field of schizophrenia.

Data Quality Concerns

Bracket was very pleased to have the opportunity to present during the 5th Biennial Schizophrenia International Research Society Conference and is excited to share our research on Erroneous Interviewing and Rating Patterns Detected During Screening Predict Subsequent Quality Issues.


FULL CITATION:  Erroneous Interviewing and Rating Patterns Detected During
Screening Pedict Subsequnt Quality Issues
MEETING: 5th Biennial Schizophrenia International Research Society Conference
POSTER: Erroneous Interviewing and Rating Patterns Detected During
Screening Pedict Subsequnt Quality Issues
AUTHORS: David Daniel, MD; Alan Kott, MUDr
YEAR: 2016

Using “Bring Your Own Device” for ePRO in Clinical Trials

2016-04-08 11.34.34The adoption of “Bring Your Own Device” or BYOD in clinical trials has been slow, but the topic generates a fair amount of discussion and debate. The pragmatic case for simply allowing patients in research programs to use their own mobile phones as tools to collect and report data is easy to make. But there are numerous considerations that make this a hard decision.

BYOD is gaining acceptance. Every stakeholder involved in the research process has something to gain by improving how we do this. One exciting example of this is ResearchKit from Apple, “a software framework for apps that let medical researchers gather robust and meaningful data.” The mPower Mobile Parkinson Disease Study is just one innovative implementation of this framework in a BYOD setting.

Last year, the ePRO Consortium, a group of eCOA providers working under the umbrella of the Critical Path Institute, published a comprehensive paper detailing those considerations, and carefully articulating how and when to navigate through any potential challenges. Some important findings;

  • Reducing cost is an important benefit, but not the only benefit.
  • Privacy Concerns in some cases can be amplified when using BYOD.
  • “Mixed Modes” concerns regarding measurement equivalence require specific planning and accommodation.

Picture1While these considerations, and regulatory opaqueness, have slowed adoption, there are many instances where BYOD has been successful, either in it’s implementation or in the eventual success of a clinical trial.

Adoption of new technology has always been a challenge in clinical research. For technology providers and technology evangelists, the most common challenge heard from a sponsor is “Well, will the FDA accept my data?” or “Have any successful NDA’s included this kind of technology?” It’s a chicken-or-egg problem that can be solved through open dialogue and deliberate planning.

What is lacking from the discussion on the use of BYOD is more hard data on outcomes and experiences. As sponsors begin the process of utilizing BYOD in their studies, the data from the outcomes collected this way, or data related to the mode of collection and methodology, will be useful to the field in understanding how this can make our research more effective for patients.

scdmThis fall, at the Society for Clinical Data Management Annual Conference in San Diego, Adam Butler from Bracket will chair a Panel Discussion titled “Challenges to the Adoption of Bring Your Own Device in Clinical Trials.” The Call for Abstracts is now open. If you have insight from your own work in implementing BYOD in a clinical trial, this will be a good opportunity to share those experiences with an audience eager to learn more. You can find the submission guidelines here.