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Below are just a few of the ways the Partner Network helped move the needle for the CCTS in 2020.

• The Partner Network worked closely together, continuing collaboration and strategy through virtual versions of their Executive Committee meetings, monthly Partner Teleconferences, and Internal and External Advisory Committee meetings.
• The CCTS investigators from across the Partner Network continued to catalyze discovery to address chronic disease and health disparities in a variety of CCTS award programs, including the Therapeutic Advancement Initiative, the CCTS Interdisciplinary Network Pilot Program, the Deep South Mentored Career Development Program (KL2), and the Predoctoral Clinical/Translational Research Program (TL1).
• The move to virtual trainings, meetings and programs made gatherings more accessible for the entire Partner Network. This shift allowed even more partner interaction and camaraderie as we continued to build a community of scholars.
• Population genomics research is an area where partnership really shined in 2020. Our region includes populations that are saddled with a high burden of chronic, life-threatening diseases such as obesity, diabetes, hypertension, and cancer. The CCTS has four major population genomics initiatives underway, all working to offer solutions to chronic disease. This portfolio set the stage for even greater success with new program grants to advance Precision Animal Modeling (C-PAM), participation in the eMERGE Network and genomic medicine in pediatrics (BabySeq2).

This year called for innovation and perseverance in the conduct of CCTS Training Academy initiatives like never before. Below you’ll find a few highlights from this year:

• With digital engagement already a tenet of the Training Academy, the pandemic pivot to virtual training was swift and without interruption, and attendance for virtual trainings has been robust. Programs included the Specific Aims Intensive and the Grant Proposal Development Academy.
• The Driving Research: An Interdisciplinary, Vibrant, Engaged Network (DRIVEN) program continued to support a diverse cohort of scholars actively engaged in research and career development activities. DRIVEN experienced a 167% increase in membership and shepherded three Research Supplements to Promote Diversity in Health-Related Research (in Medicine, Nutrition Science and Public Health).
• The Predoctoral Clinical/Translational Research Program (TL1) has significantly grown in diversity of the institutions, disciplines, gender, race and ethnicity represented in the training cohort. In 2020, eight of the 15 selectees represented Partner Institutions, up from five the previous year.
• In February, the 5^th Annual CCTS Bioethics Forum hosted record-breaking attendance and covered Engagement of Diverse Populations in Research: Challenges & Lessons Learned from Cohort Studies.
• The 2020 Clinical and Translational Science Training Program (CTSTP) welcomed the largest cohort seen to date!

The purpose of CCTS Special Modules is to help clinical and translational investigators connect with and leverage expertise and unique capacities found within the CCTS Partner Network. Here is a snapshot of the progress made in this domain in 2020.

• The Undiagnosed Diseases Program (UDP) continued its mission to evaluate patients with chronic, undiagnosed diseases and providing access to whole exome and whole genome DNA sequencing in order to identify potential therapeutic targets which can serve as a pipeline to therapeutic discovery. UDP has an ~ 40% rate of diagnoses, with all patients seen having undergone previous extensive workups that failed to achieve a diagnosis. One 2020 diagnosis resulted in expanding the phenotype of a rare form of progressive neuromuscular disease diagnosed in a UDP patient.

• The Hub was recently awarded an NIH-sponsored Center for Precision Animal Modeling (C-PAM), one of three in the country. The C-PAM seeks to analyze sequence variants efficiently and cost-effectively to pursue disease mechanisms and targeted therapeutics. It does so by creating a portal for genomic medicine-enabled projects (e.g., via UDP) leading to the development of computational and animal models for further experimentation to understand biologic impact of genetic variants, in part, by CCTS Partner Network investigators.

• The CCTS Partner Network experimented with a new assay development model, inviting investigator-initiated projects seeking to develop and/or refine an experimental platform –model, reagent, assay, etc. – to accelerate the progression of promising therapeutics along the translational pipeline towards clinical applications and ultimately health impact. Through this CCTS Therapeutic Advancement Initiative (TAI), investigators established novel high-throughput screening platforms, developed organoid methods to assay drug analogs, and demonstrated effectiveness of potential interventions in preclinical models of transplant, multi-organ failure and acute lung injury.

• The All of Us Research Program opened the Researcher Workbench beta version and is inviting researchers to apply for access and to explore the initial dataset and tools. The new Researcher Workbench is a secure, cloud-based platform that offers researchers an opportunity to execute rapid, hypothesis-driven research and build new methods for the future.

• The Alabama Genomics Health Initiative (AGHI) set the stage in 2020 to embedded enrollment into Family Medicine clinical practice in 2021 in Birmingham, Hoover, and Selma, Alabama, setting the stage for precision care that is better-informed and more cost-effective.

Over the past year, the Clinical Translation Domain kept clinical studies moving forward. Below are just a few of the ways Clinical Translation helped move the needing for health in 2020.

Clinical Trials

• Despite the effects of the modified business model due to the COVID-19 pandemic, clinical trial expenditures at the CCTS Hub (UAB) continued to grow by an average of 16% year-over-year. In 2020, this growth enabled advances such as device testing in structural heart and lung diseases, novel therapies for advanced solid tumors, new interventions for mental health conditions, neurologic diseases, genetic disorders, and more!

CITP on the Go

• The CCTS launched our first clinical trials investigator podcast, CITP on the Go, allowing busy investigators to connect with the CCTS Clinical Investigator Training Program and expert presenters, at their convenience and at their own pace.

Clinical Trials Kiosk and New Investigator Onboarding Web Resource

• The newly refined CCTS Clinical Trials Kiosk now contains even more resources, budget tools, source documents, templates, and more for clinical trials investigators, all in one handy place. Additionally, the Clinical Research Support Program (CRSP) team helped created a new onboarding resource for those investigators new to UAB clinical research.

Setting the stage for Precision Bionutrition

• The CCTS Bionutrition Unit has helped facilitate numerous feeding studies with a wide range of dietary requirements. Most recently, supported research includes studies on the ketogenic diet, DASH diet, and diets controlled for specific nutrients such as phosphorus, oxalate and sodium. Facilities, research experience, and trained staff put the Bionutrition team in an unique position to support future research in the new and upcoming area of Precision Nutrition, which promotes an individualized approach to nutrition and diet based on various metabolic, genetic, behavioral, and environmental factors.

Clinical Research Unit Expansion Plans

• As the pandemic halted many business operations, and departments pivoted to a virtual format, the Clinical Research Unit (CRU) remained open and steadfast. Construction has begun on a planned facility expansion to enable the CRU to accommodate more studies requiring extended stays.

The Community Health Innovation Awards call for innovation (it’s in the name, right?), and what could make innovation even more critical than when your organization lands grant funding right before a pandemic hits? We’ve checked in on all five CHIA recipients to see how they’ve fared since COVID-19 took its hold, and here are a few updates.

Chocolate Milk Mommies (Lindsey Rice, Project Director)

Mission: Chocolate Milk Mommies (CMM) is a parenting group working to remove the stigma surrounding breastfeeding—especially in public—in black communities. 

Project Updates:

• Continued their in-home counseling by purchasing a HIPPA-compliant virtual platform for ‘visits’
• Used their resources to distribute COVID-19 relief packages that included masks, hand sanitizer and health information

Growth Potential:

• Received additional funding ($10K) from the Community Foundation of Birmingham, and is exploring expansion of their efforts into Tuscaloosa and Mobile, Alabama
• Has grown their reach on social media, and now hosts over 1,200 people in their Facebook support group    

Link & Lease (Jared Sluss, Project Director)

Mission: Link and Lease/Druid Hills Alliance exists to create a Birmingham where everyone has a place they can call home, by working with housing insecure individuals who deserve an opportunity for fair housing. 
 
Project updates:

• Continues renovating two homes in a historic neighborhood in Birmingham, Alabama, creating pathways for home ownership for underrepresented communities
• Identified a piece of property in Druid Hills that will serve as a local restaurant, which will be the only establishment in the area not associated with the Birmingham, Alabama “Uptown” area. This effort to address the food insecurity in the neighborhood was led with the community in mind, making selection decisions.

Offender Alumni Association (Dena Dickerson, Project Director)

Mission: Offender Alumni Association is dedicated to its mission to empower former offenders and their family members to actively engage in reducing crime and restoring communities. 
 
Project Updates:

• Pivoted seamlessly to online sessions with program participants
• Received a $20,000 donation from United Way Worldwide

Looking Ahead:

• Secured an additional pledge to the program from an anonymous donor and developed a new partnership with B & C Development to assist with a 6-week introductory carpentry class for program participants
• Partnered with UAB Criminal Justice undergraduate student to create a tutoring program with the members of Offender Alumni Association

GASP (Michael Hansen, Project Director)

Mission: GASP is a health advocacy organization with a mission to advance healthy air and environmental justice in Birmingham

Project Updates:

• 25 total air quality sensors have been built, working in partnership with a local group of engineers and designers, and 14 are up and running

Partnering for Success:

• A 1,500+ acre community park in the city of Birmingham has agreed to use their tract of land to install two more sensors

Youth Talk United (Erika Perry, Project Director)

Mission: Youth Talk United provides mentoring, young adult leadership, parent involvement and sports, all as part of its mission to continue to empower and inspire the community. 

Project Updates:

• Zoom has actually allowed more freedom with members talking and being more comfortable in sharing personal challenges
• The Community Foundation of Birmingham provided a grant to Youth Talk to address mental health concerns during the pandemic

Building Partnerships:

• Youth Talk United connected with the Birmingham City Council to create volunteer opportunities for the youth they serve
• Leadership has connected with a local McDonald’s to provide jobs for any participants of Youth Talk United at any McDonald’s location in the Birmingham metro area

Special thanks to Shauntice Allen, PhD, MA, who leads the CHIA effort, and produced the information for this piece.

In a year that started out like any other and quickly forced a shift to new, innovative, and often challenging means of conducting research, the CCTS experienced many successes of note. The following accomplishments couldn’t have come to fruition were it not for the dedication of the individuals and teams that make up CCTS Research Commons. While there are many highlights from this year, below are a few notable accomplishments:

• CCTS research partnerships resulted in $39M new programmatic awards and an additional $5.8M to support COVID investigation.
• CCTS added 650 new members from across the tri-state Partner Network.
• The CCTS was among the first four institutions to join and send data to the National COVID Cohort Collaborative (N3C), a large data enclave that currently integrates 2.6B rows of data on 2.5M patients across 36 sites to gain crucial insights into population health.
• Informatics for Integrating Biology and the Bedside (i2b2) was leveraged by 244 unique investigators for their projects through 64,963 user sessions and resulting in over 600 limited data set downloads.
• CCTS Informatics expanded i2b2 to include 7.1B observations across 1.6M concepts on 1.56M patients.
• CCTS BERD consultations adapted seamlessly to the virtual format, providing scientific design and analytic expertise to 295 researchers on over 350 research projects.
• Kaizen-R2T, the self-directed training in Rigor, Reproducibility and Transparency, launched its first international game this year and hosted 204 participants from 29 institutions.
• Over $3.1 million was awarded to the CCTS to help extend the reach of the I-Corps@NCATS program nationally over the next three years and to engage entrepreneurial teams with game-changing biomedical applications that may improve health. 
• The Southeast Health Alliance for Research (SHARe) continued to support multi-site clinical investigation, identifying study team personnel and recruiting affiliate sites for on-going and new studies, including pivotal COVID treatment trials.
• Shifting to a virtual format, the CCTS conducted more than 152 panels, helping investigators and trainees create more competitive proposals through expert peer review.
• CCTS Pilot awardees overcame pandemic-related delays and challenges to advance critical discovery research in cardiac care, neurovascular function, novel diagnostics, age-related cell instability, health disparities, diabetes risk and breast cancer.

The CCTS Partner Network connects investigators across the Deep South through collaborative research and training efforts. This collaboration was at the forefront of CCTS COVID-19 research and response efforts over the past year.

• The CCTS Southern Commonweal is a platform to exchange ideas and successful strategies in the engagement of communities that spans the Partner Network. Early on in the pandemic, the Mississippi Department of Health launched a community survey to help understand community trust of COVID-19 information, and this work led to a rapid mobilization to provide information to vulnerable communities to reduce the stigma around COVID-19. The strategies to achieve this outreach were disseminated regionally via Southern Commonweal in an effort to inform and to facilitate similar initiatives across the region.
• The NIH Community Engagement Alliance (CEAL) Against COVID-19 Disparities program supports teams in 11 states, including CCTS Partners in Alabama, Louisiana, and Mississippi. CEAL leverages the Southern Commonweal for sharing of successful strategies in engagement.
• Despite the social distancing required over the last year, researchers within the CCTS Partner Network were able to come together through new and evolving collaborative supports. The National COVID-19 Cohort Collaborative (N3C), which launched in early summer, created a secure, central database of electronic health records from coronavirus patients and the All of Us Research Workbench allows the sharing of large data sets.

Take a look at a few of the ways the Training Academy thrived despite the COVID-19 outbreak.

• In the early spring, the Training Academy quickly realized a need for orientation resources to help investigators acclimate to virtual teamwork and to continue to excel in their research from a distance. Through partnerships with experts within our Partner Network, we were able to offer a range of trainings from time management to “How to Thrive in a Virtual World,” to meet this need.

• CCTS Training leaders played a critical leadership role in nurturing bidirectional conversations and critical perspective-sharing surrounding COVID-19 misinformation and mistrust, testing, therapeutics, and vaccinations.  In partnership and synergy with RADx-UP and CEAL initiatives within Alabama and across the region, CCTS investigators and Training Academy alumni supported research and outreach efforts to impact the populations we serve.

• The CCTS, through its Training Academy, facilitated multiple discussion venues, including “Morning Coffees”, “Afternoon Teas” and CCTS Forums, to engage teams to share the latest operational guidelines for conducting research in a quickly evolving pandemic-affected landscape.

The CCTS Special Modules Domain has supported and facilitated many efforts toward understanding and responding to the COVID-19 pandemic.

• COVNET: Large-scale Genome-wide Association Study and Whole Genome Sequencing of COVID-19 Severity: This international effort, organized by the NIH, utilizes a “crowdsourcing” approach to accrue samples from multiple centers throughout the U.S. and Canada, including CCTS Partner Institutions LSU and UAB. The aim of COVNET is to genotype DNA from upwards of 40,000 COVID-19 positive individuals to investigate both common and rare variants associated with differences in disease outcome using a case-case design.

• Investigators at CCTS Partner Institutions Louisiana State University, University of South Alabama, and University of Alabama at Birmingham have assembled the expertise, biosafety measures and technology in viral sequencing to help further the efforts for understanding COVID-19 infection, made all the more imperative in light of novel SARS-CoV-2 variants.

• Work by Richard Whitley, MD, UAB Professor and Co-Lead of the CCTS’s Drug Discovery initiative, and others came to center stage as the drug, Remdesivir, previously developed as a treatment for MERS, was identified as an effective intervention in managing COVID-19 infection.

Here are a few of the ways the Clinical Translation domain contributed to important COVID-19 research efforts.

• The CCTS collaborated on a national seroprevalence study to understand COVID-19 herd immunity in the United States. The study went from concept to full approval in a matter of weeks, enrolling 10,000 study volunteers just weeks later, testifying to the power of teamwork that is central to the CCTS’ mission.

• The CCTS Specimen Processing and Biorepository Unit (SPAN) offers specialized support for the entire continuum of research specimen-associated needs, and the burden of additional COVID-19 processing was met with an incredible tenacity. The SPAN team partnered with the Alabama Vaccine Research Clinic, Pathology & Microbiology Departments, CFAR Clinical Core, and others to support the COVID-19 Enterprise Biorepository, which manages a variety of biospecimens from over 1700 participants.

• The Child Health Research Unit (CHRU) continued to support dozens of pediatric clinical studies despite pandemic limitations, setting the stage for critical investigation of the youth impact, treatment and prevention of COVID-19.

• The Clinical Research Support Team (CRSP) had the privilege of being asked to help provide phlebotomy and nurse coordinators for the Moderna COVID-19 vaccine trial at St. Vincent’s Hospital in Birmingham, Alabama. The CRSP team formed new relationships, followed good clinical practice, and furthered an important trial that impacts our communities.

• The CCTS, through efforts at the Hub (UAB) as well as across the Partner Network, has been deeply involved in the COVID-19 pandemic response from both the treatment and prevention (vaccine) fronts. These efforts have included, but are not limited to, the implementation of the ACTIV (Accelerating COVID-19 Therapeutic Interventions & Vaccines) protocols coordinated by the NIH at SHARe sites such as Tulane University and Ochsner Health, in addition to a myriad of outpatient and inpatient convalescent plasma trials coordinated by Johns Hopkins University through the Trial Innovation Network (TIN). So far, hundreds of patients have participated in dozens of trials just at the Hub, with enrollment ongoing for many.

COVID-19 brought together many communities and stakeholders to battle the novel coronavirus. Here are just a few snippets from efforts that came together rapidly.

• In April and May of 2020, the UAB School of Public Health and CCTS Engagement of Communities Domain, with local churches and community stakeholders, organized three public, virtual events addressing the impact of COVID-19 on communities. These events, “COVID-19 Impact on the Black Community,” “COVID-19’s Impact on Women,” and “COVID-19’s Impact on Food and Shelter Inequality,” were moderated by Drs. Shauntice Allen and Faith Fletcher, and offered an opportunity for community members to ask questions and hear directly from the experts, during a time when information about the disease was still very limited. This successful series, with livestreams exceeding 53,000 views, was featured in the December 2020 issue of Insight into Diversity.

• Community Engagement Alliance Against COVID-19 Disparities (CEAL) Researchers across the CCTS are part of a National Institutes of Health-funded effort for outreach and engagement efforts in ethnic and racial minority communities disproportionately affected by the COVID-19 pandemic. This effort is chiefly designed to overcome scientific mistrust, to address COVID-19 misunderstanding and to bolster diverse participation in clinical investigation. The NIH CEAL program supports teams in 11 states, three of which are in the CCTS Partner Network. CEAL leverages the Southern Commonweal for sharing of successful strategies in engagement.

• CCTS investigators joined leaders in the UAB Center for AIDS Research and the Minority Health and Health Disparities Research Center as part of the NIH RADx-UP programto support projects designed to rapidly implement COVID-19 testing strategies in populations disproportionately affected by the pandemic.

The CCTS is grounded in the power of collaboration, and when it came time to battle the virus that causes COVID-19, a coordinated effort was even more essential.

The COVID-19 Enterprise Research Initiative, was mobilized just weeks after the pandemic was declared, and it continues to shepherd the safe and efficient consent process and collection of specimens and clinical data. CCTS Informatics, with leadership by the Center for Outcomes & Effectiveness Research, Informatics Institute and multiple schools, continue to coordinate clinical data and longitudinal follow-up for rigorous secondary analysis that ensures efficient and respectful engagement of research participants. The effort has shown how much more can be accomplished when everyone comes to the table.

The COVID-19 Enterprise Biorepository team has worked hard to support COVID-19 research, and nearly 1,800 individuals have consented to be part. The biorepository has been especially impressive in its enabling of:

• Recruitment of individuals with current or previous infection or symptoms from both hospitalized and ambulatory settings (or autopsy)
• Collection of a variety of specimen types, including new and/or remnant blood; tissue; oral (cheek, throat)-, nasal-, nasopharyngeal-, vaginal-, rectal- swabs; endotracheal aspirates; urine; saliva; etc.
• Linkage of specimens to clinical information in the electronic health record, external sources (e.g., health claims data, death index) as well as the collection of data through surveys and other PRO-instruments
• Recall of participants for longitudinal follow-up and provision of additional specimens
• Specimen and data sharing for multi-site investigation, including genetic studies

To learn more about this effort, including the working teams and leadership behind it, visit the COVID-19 Enterprise Research Initiative page.