2018-2019 Annual Report

2018-2019 Annual Report

In addition to sharing important research, this year’s annual report contains stories that feature our collaborators and partners, demonstrating how we work with our Duke colleagues, sponsors, and other key stakeholders to ensure the DCRI and Duke remain at the forefront of innovation in clinical research. Click on the buttons below to jump to various sections of the report, including stories, videos, and key stats.

Curtis

Welcome from the Interim Executive Director

I am delighted to share this year’s DCRI annual report, an especially meaningful edition for me as I complete more than a year as interim executive director. The stories here reflect fully how the DCRI is advancing clinical research through groundbreaking studies led by exceptional teams of faculty and operational staff. Under the leadership of our research teams, we continue to introduce new methods and pursue innovative approaches in clinical research for the most pressing issues in patient care. Read more from Lesley Curtis, PhD.

Reflection from the Head of Research Operations

As a member of the DCRI team for more than 12 years, including as head of research operations now, I am especially proud to represent our operational teams in this year’s annual report. Inside, you will find a sampling of the hundreds of projects led by our dedicated clinical research project teams. Nowhere else will you find an academic research organization with the depth of operational expertise to translate thought leadership from the pages of a protocol through study start-up, recruitment, retention, and returning results to our valued study participants. Read more from Ty Rorick.

DCRI, Ty Rorick
ARISTOTLE was honored as 1 of 12 studies that were "practice-changing and lifesaving".
AEGIS-II will enroll over 17,000 patients at about 1,000 sites worldwide.

One Size Doesn’t Fit All: Traditional Trials Meet Pragmatic Approaches

Michael Felker, MD, MHS, a cardiologist at the DCRI, invited his colleague, fellow DCRI cardiologist Adrian Hernandez, MD, MHS, to discuss the evolving clinical research landscape and how the DCRI is responding by continuing to build on its deep expertise of delivering traditional clinical trials while also incorporating pragmatic approaches. View the video conversation above, or read the annual report story.

Read highlights on Traditional Trials from the report:

Answering Important Questions for Older Adults with a Pragmatic Trial

Karen Alexander, MD, discusses PREVENTABLE, a new pragmatic trial she will lead to ascertain whether statins can help prolong survival free of dementia or physical disability in adults 75 years of age or older. PREVENTABLE is the largest pragmatic clinical trial with placebo-controlled drug assignment to date. It is also the first statin trial with a non-cardiovascular primary outcome. View the video at left or read the annual report story.

Industry average recruitment rate for HF studies: .02 patients per site per month; TRANSFORM-HF recruitment rate: >2 patients per site per month.

Taking a Pragmatic Approach Impacts Enrollment

The DCRI’s Robert Mentz, MD, speaks with Patrice Desvigne-Nickens, MD, a medical officer in the Heart Failure and Arrhythmias Branch of the NHLBI and project officer for TRANSFORM-HF, a pragmatic clinical trial on heart failure. Learn what they have to say.

Partnering to Build a Research Network

The DCRI is partnering with Cerner, the world’s largest electronic health record (EHR) company, to conduct clinical research using Cerner’s cloud-based platform. Learn more about the partnership.

Biomedical Data Science across Duke

Laine Thomas, PhD, associate director of DCRI Biostatistics, sat down with David Page, PhD, chair of Duke Biostatistics & Bioinformatics, who is new to his role as of this year, for a discussion on the future of biomedical data science, as well as how machine learning techniques will be incorporated in this work. Read their insights.

Ensuring Data Quality

Data are easily accessible, but not all data are well-suited to answer a given clinical research question. A team that includes DCRI faculty is working to build frameworks to assess whether data can be used in research studies. Learn more.

35 data checks which translate into 1,200+ data check measures
CEC now performs about 30,000 adjudications per year, in comparison with 5,000 per year about 5 years ago.

Innovating Adjudication

As the DCRI’s Clinical Events Classification (CEC) group grows, its leaders are seeking innovations to make their work more efficient. View the video conversation above or read the annual report story.

Valuing Patients as Equal Stakeholders

Renee Leverty, BSN, MA, program lead for DCRI Stakeholder Engagement and DCRI Research Together, discusses how her team works with patients and patient advocates to incorporate the patient perspective in every stage of clinical research, from study design to dissemination of results. View the video at right, or read the annual report story.

Learn more about how the DCRI values stakeholder collaboration:

Helping Clinics Get Evidence-Based Therapy to Patients

Neha Pagidipati, MD, MPH, faculty leader for the COORDINATE-Diabetes trial, discusses the study with Monica Reed, MHA, a clinical research associate who is helping to lead the intervention arm of the trial. The study’s goal is to ensure that patients with diabetes and cardiovascular disease receive life-saving evidence-based therapies. View the video above or read the annual report story.

Although more than $100 billion is spent on biomedical research each year, it can take over a decade for study results to be adopted in clinical practice.

Stakeholders Share Ideas

The DCRI convenes DCRI Think Tanks on a regular basis to inspire collaboration around solving the most critical gaps in clinical research. At its most recent event, participants discussed implementation science. Read more.

Patients_hospital_DeVore

Improving Quality for Better Outcomes

CONNECT-HF, a DCRI-led pragmatic clinical trial, is focusing on improving quality initiatives so that patients with heart failure receive better care and spend less time in the hospital. Learn about the study.

A Longstanding Partnership Built on Trust and Quality

The DCRI often partners with other academic research organizations around the world, such as the Canadian VIGOUR Centre (CVC), in their work to deliver clinical trials. The DCRI’s head of research operations, Ty Rorick, sat down to discuss the success of these collaborations with Tracy Temple, associate director of clinical trials at the CVC. Read their conversation.

Transforming Clinical Trials

No single stakeholder can successfully address the challenges in clinical research. Because of this, the Clinical Trials Transformation Initiative, a public-private partnership co-founded by Duke University and the FDA in 2007, brings together stakeholders from across the clinical research ecosystem to create new solutions for better, more efficient clinical trials. Learn more.

Fostering Collaboration to Improve Pragmatic Trials

The DCRI’s Myles Wolf, MD, MMSc, is exploring how to best manage blood phosphate levels in patients receiving dialysis through the HiLo trial—one of six large-scale pragmatic clinical trials from across the U.S. that were added to the portfolio of innovative Demonstration Projects this year by the NIH Health Care Systems Research Collaboratory program (NIH Collaboratory). Learn more.

Ushering in New Services: Motivating Behavior Change

Charlene Wong, MD, MSHP, and Chuck Scales, MD, co-directors of the Behavioral Research Intervention Science Center, discuss how different types of incentives can be used within clinical research to encourage behavior change in participants and providers.