DCRI study honored as practice-changing by New England Journal of Medicine

May 29, 2019 – The ARISTOTLE study found that apixaban was superior to warfarin in preventing stroke and decreasing risk of bleeding for patients with atrial fibrillation.

A DCRI-led study published in 2011 was recently honored by the New England Journal of Medicine’s editor-in-chief as one of 12 studies that has most changed clinical practice since 2000.

The ARISTOTLE study found that apixaban was superior to warfarin in treating patients with atrial fibrillation who have an increased risk of stroke. Apixaban was not only more effective than warfarin in preventing stroke, but also caused less bleeding. The trial included more than 18,000 patients from 39 countries.

Prior to his upcoming retirement, Jeffrey Drazen, the editor-in-chief of the New England Journal of Medicine, looked back at the science the journal published over the 19 years he spent in the role. From more than 80,000 submissions and nearly 4,000 published studies, he selected 12 to highlight as “Drazen’s Dozen” of “practice-changing and lifesaving papers.”

“This is really quite an honor, as there are plenty of trials that are equally important,” said the DCRI’s Christopher Granger, MD (pictured), who served as a primary investigator and co-chair on ARISTOTLE. “This is a tribute to a great collaboration—both among so many people at the DCRI and worldwide, especially my co-chair Lars Wallentin from Uppsala University in Sweden.”

The DCRI team also credits its industry partners, Bristol-Myers Squibb and Pfizer, with contributing to the success of ARISTOTLE. The DCRI’s John Alexander, MD, MHS, who worked on ARISTOTLE, started studying apixaban with colleagues from Bristol-Myers Squibb in 2005, but the drug had an unfavorable risk-benefit profile in patients with acute coronary syndrome. By contrast, ARISTOTLE, according to Alexander, was “a home run.”

“It has been a rare privilege to be so intimately involved in the development of a drug that has made, and is making, such a difference in patients’ lives,” Alexander said. “I’ve been involved with a lot of trials, but none have had as great an impact on patient care as ARISTOTLE.”

Apixaban is now the most commonly initiated drug for stroke prevention for patients with atrial fibrillation, Granger said. It is easier to use than warfarin because warfarin is associated with several food and drug interactions and requires monitoring.

“It is gratifying to be able to generate evidence that can be used to help improve patients’ lives,” Granger said. “This honor aligns nicely with the DCRI’s mission to share knowledge that improves patient care around the world—we have been able to publish and share knowledge gained from ARISTOTLE that we now use every day in our practice.”

The DCRI’s Renato Lopes, MD, PhD, started working on the trial as a DCRI fellow, and later became part of the core leadership team of the study as a DCRI faculty member.

“When you work on a trial for so long and put in so much effort, it becomes part of your life,” Lopes said. “We are pleased that ARISTOTLE is still generating knowledge and helping patients all over the world, and it’s extremely rewarding and gratifying to be recognized for the work done by so many to make the trial successful.”

In addition to the primary manuscript published in 2011, there have been over 60 publications from ARISTOTLE with over half published in high-impact journals.

Other DCRI faculty who contributed to ARISTOTLE include Hussein Al-Khalidi, PhD, who was the statistician, and Sana Al-Khatib, MD, MHS, who ran clinical events classification for the trial. Many operational staff also contributed to ARISTOTLE’s success.

DCRI faculty member recognized by American Gastroenterological Association

March 4, 2019 – The DCRI’s David Leiman, MD, MSHP was selected as one of 18 participants in this year’s AGA Future Leaders Program.

DCRI gastroenterologist David Leiman, MD, MSHP will be a member of the third class of the Future Leaders Program,  the flagship leadership development program offered by the American Gastroenterological Association (AGA).

The 18-month Future Leaders Program was designed for early career physicians and scientists who have the potential to make a significant impact in their specialty area. The program seeks to shape its participants into the future leaders of the AGA, their home institutions, and within the field of digestive diseases.

“The 2020 class of AGA Future Leaders represents the next generation of leaders in our field,” said Darrell S. Pardi, MD, MSc, AGAF, co-program chair for the AGA Future Leaders Program. “Along with my co-chair, Sheryl Pfeil, MD, AGAF, and the esteemed mentors and faculty participating in this program, we look forward to cultivating these rising stars who stand out for their current achievements, commitment to advancing the field, and potential for future success.”

Leiman’s research focuses on esophageal diseases, swallowing disorders, and gastrointestinal cancer prevention. He is particularly interested in health care delivery, with a focus on clinical effectiveness, practice quality and patient outcomes. He is already involved in the AGA through membership on its Quality Measures Committee and was recently selected as Chair-Elect.

“I am honored to be selected as a participant of the Future Leaders Program and to join an exciting group of talented colleagues from across the country,” Leiman said. “I am looking forward to learning new leadership strategies that can be applied across my research and clinical practice as well as building long-lasting relationships with my peers and future mentors.”

In the Future Leader Program, Leiman joins colleagues from Columbia University, Harvard University, the University of Pennsylvania, and the University of North Carolina at Chapel Hill, among other institutions.

“David has been an outstanding recruit to Duke GI and the DCRI,” said Andrew J. Muir, MD, MHS, director of gastroenterology and hepatology research at the DCRI. “This selection by the AGA recognizes David’s accomplishments in this early phase of his career.  Through his research in esophageal diseases, he is poised to make significant contributions to the field and to our society.”

Leiman earned his medical degree from Vanderbilt and completed both an internal medicine residency and a fellowship in gastroenterology and hepatology at the University of Pennsylvania. He joined the Duke faculty in 2015 and the DCRI in 2017.

Scholarship to honor Kevin Thomas’ advocacy for underrepresented populations

January 23, 2019 – The Kevin L. Thomas, MD Scholarship will be awarded to high school students interested in medical careers.

The DCRI’s Kevin Thomas, MD, has devoted his career to eliminating disparities for patients with cardiovascular disease and helping junior faculty from underrepresented populations advance their medical careers. Thomas’ efforts will now extend to high school students thanks to a new scholarship that has been established in his name.

The Kevin L. Thomas, MD Scholarship will benefit participants in the Health Professions Recruitment and Exposure Program (H-PREP). H-PREP, which has programs at medical schools nationwide, introduces high school students from underrepresented populations to careers in the health sciences. The scholarship will allow H-PREP administrators at Duke to increase the amount of money provided to each participant.

Thomas, who serves as assistant dean for underrepresented faculty development at the School of Medicine and director of faculty diversity and health disparities research at the DCRI, said that at each step in his own career — from medical school to residency to a fellowship to becoming a faculty member — he has identified mentors and been supported by a network of peers.

“As I have advanced through my career, it’s always been important to give back and serve in that capacity for others,” Thomas said. “I find enjoyment in my own success, but maybe even more enjoyment in the success of others’ whose lives I can touch, whether it’s through mentorship, sponsorship, or giving general advice about career paths and development.”

In 2017, Thomas launched a yearlong program to provide professional development for historically underrepresented groups. The first cohort in the program, called Academic Development, Advocacy, Networking, Coaching, and Education for Underrepresented Populations (ADVANCE-UP), was composed of 13 faculty from eight different departments. Most of the participants were Hispanic, Latino, or African-American, and 11 of them were women, which Thomas said fostered important discussions about the intersection between race, ethnicity, and gender.

At the December closing banquet for the program, the cohort had a surprise for Thomas — they had all contributed to establish a scholarship in his name. ADVANCE-UP participants contributed $1,500 to the scholarship, and Duke School of Medicine Dean Mary Klotman matched the funds for a total of $3,000.

“The creation of this scholarship is such an affirmation of Kevin’s impact,” Klotman said. “It allows us to honor him for his incredible work as a leader and mentor, and it provides funding to help introduce research and medicine as a career to high school students from underrepresented populations. Increasing the pipeline of talented, passionate and diverse health professions students is critically important to the future of health care.”

Thomas said he was surprised by the announcement. “It’s one of the most special things I’ve ever been awarded,” he said. “I feel incredibly honored that they thought enough of me to create something like that.”

Gianna Hammer, PhD, an immunologist who has worked at Duke for five years, was a participant in the ADVANCE-UP program. She said the cohort wanted to think of a meaningful way to honor Thomas and all that he has worked for.

“The ADVANCE-UP program was a transformative experience,” she said. “Not only did it provide us with a sense of community, but it empowered and encouraged us. We wanted to also empower and encourage others, and to show Kevin that the program he created resonated. That is why we created this scholarship.”

Jennifer Dominguez, MD, another ADVANCE-UP participant and an obstetric anesthesiologist who has been at Duke for six years, said the group chose H-PREP because the program furthers Thomas’ mission.

“We felt that H-PREP was an appropriate cause to raise money for because the program enables more individuals from underrepresented populations to have access to the health sciences, and the experience may inspire them to pursue a career in medicine,” Dominguez said. “Our hope is that future cohorts of ADVANCE-UP faculty will continue contributing to this scholarship to make a sustainable impact.”

The first year of the scholarship funding will be distributed among the top three H-PREP students, who were evaluated on their performance after a series of interviews and a presentation.

Rita Kibicho, a current high school senior who wants to go to UNC-Chapel Hill, Duke, or Brown, set aside the money she received in her bank account, where she looks forward to using it on books for her first semester.

“I’d like to thank Dr. Thomas and everyone involved in H-PREP for recognizing the lack of support for younger people interested in medicine and trying to give us the exposure that will help them make tough decisions once they get to college,” she said.

Gianni Lacey-Howard, another scholarship recipient, will attend Duke on a full ride from another scholarship, but she said the Kevin Thomas, MD Scholarship will help her with miscellaneous costs associated with college.

Lacey-Howard intends to pursue a career in emergency medical services, a decision she made thanks to her experiences in H-PREP. “I know that medicine is the place I want to go because I enjoy helping people, and EMS is the best fit for me because I enjoy fast-paced thinking,” she said.

Thomas said recruitment for the second cohort of ADVANCE-UP is currently underway. Meanwhile, he is continuing his research at the DCRI on health disparities.

“We all work hard to contribute and make a difference and an impact,” Thomas said. “For me, this was validation of the hard work I’ve been able to do here at Duke thanks to the support I’ve had from many individuals across both the university and the medical system.”

AHA 2018: DCRI founder Robert Califf honored with Braunwald Mentoring Award

November 11, 2018 – The award is given to physicians who demonstrate excellence in mentoring young academic clinicians.

The American Heart Association (AHA) has awarded DCRI founder and former FDA Commissioner Robert M. Califf, MD, the 2018 Eugene Braunwald Award for Academic Mentoring. The award, which is given to physicians who demonstrate a consistent track record of outstanding mentorship of young academic physicians, was presented to Califf Sunday at the AHA’s annual meeting in Chicago.

For Califf, who is currently the director of Duke Forge, vice chancellor for health data science, and Donald F. Fortin Professor of Cardiology at the Duke University School of Medicine, the award recognizes a commitment to teaching and mentoring that has been a recurring theme throughout a four-decade career as a cardiologist, researcher, teacher, and public servant.

With the exception of an internal medicine residency at the University of California – San Francisco and two years serving as Deputy Commissioner and then Commissioner of the FDA, almost all of Califf’s career, including his time as an undergraduate and medical student, has been spent at Duke University. But despite his long association with Duke, Califf remains keenly aware that learning and mentoring are to be found in many places.

“Mentoring is a two-way street,” said Califf, noting that some of the most profound lessons of his career have been imparted outside of academia.

Although perhaps best known as a leading figure in cardiovascular clinical trials and as the founding director of the DCRI, Califf also taught and mentored multiple generations of academic physicians at Duke, incorporating continuous learning and teaching into the fabric of the institution he helped create. In addition to mentoring individual learners, Califf also contributed to the creation of innovative training curricula, including the DCRI Research Fellowship Training Program and the University of North Carolina-Duke Collaborative Postdoctoral Training Program.

“Without question, he is the single most important influence in my professional development as both a cardiovascular clinician and a cardiovascular clinical researcher,” said Robert Harrington, MD, chair of the Department of Medicine at Stanford University and incoming AHA president. Harrington, who spent more than two decades at Duke as a cardiologist and clinical researcher, first met Califf in 1990 upon arriving at Duke to begin a cardiology fellowship.

“He has an amazing ability to push people into areas where they are not yet accomplished, to step back and let them run a bit on their own, but to always be available when things don’t work out,” Harrington continued, noting that Califf’s mentoring style helped trainees to grow into true colleagues.

His extensive contributions as mentor at Duke were honored in 2012 with the Duke Clinical Research Mentoring Award, and the DCRI’s award given to faculty for outstanding mentorship of fellows is named in honor of Califf. Among the numerous clinicians and researchers, and academic leaders that Califf mentored are Harrington and the Chair of the 2018 Scientific Sessions, Eric Peterson, MD, MPH, – both of whom also followed Califf in the role of director of the DCRI.

During Califf’s remarks at the award presentation, he also issued a call to service. Noting that amid deep cultural and political division the United States is currently experiencing significant health challenges that threaten to erode hard-won gains in life expectancy and quality of life, he challenged his audience to continue to engage with the wider world outside of academic medicine.

“Keeping our heads down in our respective academic or clinical foxholes will not solve the daunting problems that we face both as health professionals and as members of society,” Califf said. “We must work together to re-envision and change the ways that we work to achieve better health outcomes.”

Curtis named Fellow of the American College of Medical Informatics

October 9, 2018 – Curtis and 17 others will be formally inducted into the College during the AMIA Annual Symposium next month.

DCRI Interim Executive Director Lesley Curtis, PhD, will be inducted into the American College of Medical Informatics (ACMI) on Nov. 4 at ceremonies during the American Medical Informatics Association (AMIA) 2018 Annual Symposium in San Francisco.

Curtis is one of 18 Fellows who will be inducted this year.

Lesley Curtis“The election of ACMI Fellows represents the strength and diversity of informatics with recognition of 18 accomplished individuals who are national and international subject matter experts in the science of informatics as it relates to clinical care, research, education and policy,” said ACMI President Christopher G. Chute, MD, DrPH, of Johns Hopkins University. “It reflects the growing impact of the field in health care.”

“I’ve had the pleasure of working closely with many informatics experts in the course of my career and have learned a great deal from them,” Curtis said. “It’s truly an honor to be inducted into the College.”

ACMI is an honorary College of elected Informatics Fellows from the United States and abroad who have made significant and sustained contributions to the field of medical informatics and who have met rigorous scholarly scrutiny by their peers. Incorporated in 1984, ACMI dissolved its separate corporate status to merge with the American Association for Medical Systems and Informatics (AAMSI) and the Symposium on Computer Applications in Medical Care (SCAMC), when AMIA was formed in 1989. The College now exists as an entity within AMIA, with its own bylaws and regulations.

AMIA, the leading professional association for informatics professionals, comprises 5,500 informatics professionals from more than 65 countries. AMIA and its members play a leading role in assessing the effect of health innovations on health policy and advancing the field of informatics. AMIA actively supports five domains in informatics: translational bioinformatics, clinical research informatics, clinical informatics, consumer health informatics, and public health informatics.

In addition to serving as interim executive director of the DCRI, Curtis is also chair of the Department of Population Health Sciences. A health services researcher by training, Curtis has spent her career advancing the health of patients with cardiovascular disease, eye disease, and other chronic conditions. An expert in the use of Medicare claims data for health services and clinical outcomes research, she has been a leader in using Medicare claims data along with large clinical registries and epidemiological cohort studies, including the Framingham Heart Study and the Cardiovascular Health Study.

Curtis co-leads the Distributed Research Network Operations Center for PCORI’s National Clinical Research Network (PCORnet), is co-principal investigator of the National Institutes of Health’s Health Care Systems Collaboratory, and co-leads the Data Core for the FDA’s Sentinel Initiative.

Susanna Naggie receives IDSA’s Oswald Avery Award for Early Achievement

October 6, 2018 – The award, which recognizes infectious disease specialists under the age of 45, will be presented at ID Week in San Francisco.

The Infectious Diseases Society of America (IDSA) has presented its 2018 Oswald Avery Award for Early Achievement to the DCRI’s Susanna Naggie, MD, MHS, for her novel research on the treatment of patients co-infected with HIV and hepatitis C virus (HCV).

The award, which will be formally presented at ID Week 2018 in San Francisco, recognizes members or fellows of IDSA age 45 or younger who have demonstrated outstanding achievements in an area of infectious diseases.

“I was very surprised because I had no idea I’d been nominated,” Naggie said. “When I learned that two of my colleagues from outside of Duke nominated me, it meant a lot to know they found my work meaningful. As investigators we hope that our work is impactful and ultimately translates to improved health of our patients.”

Naggie’s research focuses on the mechanisms of accelerated liver fibrogenesis in HIV/HCV-infected patients. Her work has helped define the role of pharmacogenomics and mechanistic studies of HCV treatment response in these patients, including studies of single-nucleotide polymorphisms in HCV therapy and associated liver disease.

Her group was the first to report that black patients who carried the favorable CC genotype had more immune dysregulation than non-black patients without the favorable genotype. This research has laid an important foundation for understanding the disparity in HCV treatment response in co-infected African Americans.

“I have had fantastic mentorship at Duke and in the DCRI as well as externally,” Naggie said. “[Former Gastroenterology director] John McHutchison and Shyam Kottilil enabled me to get exposure that laid the groundwork for the work that we accomplished early on and the work that is ongoing. Many others have given me opportunities, for which I am very appreciative.”

Currently an associate professor of medicine at Duke University School of Medicine, where she has been a member of the faculty since 2009, Naggie is medical director of the Department of Medicine’s Clinical Research Unit and director of infectious diseases research at the DCRI. In addition to her own research, she has served as the primary mentor for many trainees, including interns, residents, fellows, and junior faculty.

Naggie has served as a member and co-chair of the IDSA and American Association for the Study of Liver Diseases HCV guidance panel, as a member of the Department of Health and Human Services Panel on Antiretroviral Guidelines for Adults and Adolescents, and as a member or leader of several other notable national committees and groups. A graduate of Johns Hopkins University School of Medicine, Naggie completed her internship, residency, chief residency, and ID fellowship training at Duke, where she also earned a master of health sciences degree in clinical research.