Inside BD²’s Integrated Network: Coordinating Clinical & Biological Data from 4,000 Participants to Rapidly Improve Lives

When BD²’s Integrated Network set out to build its groundbreaking approach to shorten the time it takes for research to improve care for people with bipolar disorder, one of the most important aspects of that approach was designing a comprehensive, standardized data ecosystem. To build this unprecedented knowledge base, data are being collected from up to 4,000 study participants across 15 clinic sites and multiple modalities including electronic health records, imaging, wearables, and more. To eliminate challenges that often come from a lack of data standardization, the Integrated Network exercises intentional cohesion and common practices between collecting, analyzing, and deriving insights on a wide range of data from participants in the Longitudinal Cohort Study (LCS).

The Integrated Network’s centralized support services, the Clinical Coordinating Center (CCC), Data Coordinating Center (DCC),  and biorepository are essential to the functional model that ensures data is consistent across clinic sites and modalities. For example, the CCC’s team of centralized raters ensures that each participant, regardless of their location, is assessed in a consistent and rigorous manner. The DCC extracts data across sites and translates it into a common language.  The biorepository provides the infrastructure for standardized sample collection.

With the large amounts of data being collected in the LCS, consistent collection, handling, additional testing, and data dissemination are paramount to progress. To learn more about how the centralized support services ensure data standardization and contribute to the rapid translation of research to improved care, we spoke to Anil Malhotra, The Feinstein Institutes for Medical Research and BD² CCC lead, Mojib Javadi, Indoc Systems, and BD² DCC lead, and Mine Çiçek, Mayo Clinic Biobank and BD² biorepository lead.

Why were you excited to have your team join the Integrated Network and serve as the CCC/DCC/biorepository? 

Our group was thrilled to play a central role in this new exciting effort in bipolar disorder research, as we believe that the time is right for this type of clinically-oriented project.
– Anil Malhotra, MD

The integration of a longitudinal cohort study with a learning health network across multiple sites offers unprecedented opportunities to leverage data across various applications, maximizing the value the program will gain from the data being collected. The team at Indoc Systems is thrilled to be supporting the BD² program in achieving their data-driven vision, we are excited for innovative tools and analyses that the DCC will support and insights they will provide into better understanding and treatment of bipolar disorder.
– Mojib Javadi, PhD

The Mayo Biorepository has been supporting a variety of research programs for many years and we were thrilled to have the opportunity to translate those successes to another national research program. It is truly an honor and privilege to be trusted to work alongside leading researchers in the field designing solutions that curate and preserve the most scientifically useful biospecimens. Lastly, the vision, values, and rich experiences held by the BD² leadership team align with the mission and values of our Biorepository Program and Mayo Clinic as a whole.
– Mine Çiçek, PhD

What is innovative about the centralized support systems working together?

Often, these types of efforts are conducted by groups who are very distant from each other. The fact that we all get together on a regular basis and work closely with each other is an important advance.

– Anil Malhotra, MD

Bringing together the deep and broad knowledge of all central support teams provides the program with an exceptional range of complementary expertise and skill sets. Additionally, our collective teams’ collaborative approach ensures effective, coordinated solutions to the many challenges a program of this size and complexity faces.
– Mojib Javadi, PhD

Each team brings knowledge and experiences from their respective domain to the table that are critical to ensuring the success of the Integrated Network. The teams do a fantastic job of bringing their knowledge together in a collaborative manner. There is a high degree of trust amongst the groups, enabling unified support for all of the clinical sites.
– Mine Çiçek, PhD

How does the CCC/DCC/biorepository ensure that the data are standardized and comprehensive? How does this help accomplish the goals of the Integrated Network?

Our research group, under the direction of Patricica Marcy, has comprehensive SOPs to maintain clinical data harmonization and standardization. This enables the Integrated Network investigators to rapidly assess the data and will provide the engine for research discoveries as the project moves forward.
– Anil Malhotra, MD

Given the variety of data modalities in the BD² program, data standardization, and harmonization are crucial to ensuring the collection of high-value and quality data. Our engaged community of researchers and central support teams has enabled the formation of working groups that design, vet, and establish data standards through a consensus approach. This ensures broad adoption and supports downstream analyses and insight generation.

– Mojib Javadi, PhD

The biorepository has made a concerted effort to minimize the data entry and management requirements for sites when collecting biospecimens. The specimens are shipped to Mayo for centralized processing, storage, and management, where many of the important biospecimen data points are generated. The biorepository applies its comprehensive quality management system to ensure all data transferred to the DCC is cleaned and harmonized with the clinical lab results generated by Mayo Clinic Laboratories.
– Mine Çiçek, PhD

Have there been any major or surprising learnings over the past year?

It has been a pleasant surprise to see how committed the BD² supporters and administration have been to completing the goals of the ambitious project. It could not be done without them!
– Anil Malhotra, MD

The commitment of the program, sites, and central support teams to community-driven, collaborative approaches in building the foundation of the BD² program has been a very positive and rewarding experience. We look forward to building on the successes of the first year to help BD² achieve its vision.
– Mojib Javadi, PhD

In the past year, we have learned how strong, motivated, and focused this team can be when working towards a common goal. Coming in slightly later than the DCC and CCC, the biorepository was fully embraced by the team. We are grateful for the time and energy everyone has committed to ensuring goals are accomplished in a timely manner and everyone’s voice is heard.
– Mine Çiçek, PhD