Data Monitoring Committees Need Complete Data to Protect Patients

November 21, 2019 – Data monitoring committees could be provided more and better data in order to fulfill its role of protecting trial participants.

Data monitoring committees (DMCs) play a critical role in clinical trials by protecting patients—especially in studies involving high-risk populations or potentially harmful treatments—and in order to fulfill this role successfully, these committees should have access to all data at each interim review, wrote the authors of a recent paper published in the Annals of Internal Medicine.

Frank Rockhold, PhDThe DCRI’s Frank Rockhold, PhD, and Robert Bigelow, PhD, served on the writing group for the paper, which provided recommendations for summaries produced by statistical data analysis centers (SDACs) and provided to DMCs, or data and safety monitoring boards.

The authors note that often DMCs only receive the data thought necessary for making decisions about safety. However, they argue, when these groups receive limited data and information, they are lacking important context. “To fulfill its mandate to protect trial participants, the DMC needs timely access to all relevant information, including efficacy data,” the authors write.

The paper also identifies problems with reports currently produced by SDACs, which are often lengthy and difficult to digest. “To foster efficient, informed decision making, reports should be streamlined, concise documents that display important data in optimally informative ways,” the authors recommend.

In addition, the authors advocate for implementation of graphical summaries that integrate benefits and harms. Visuals could help the DMCs make more accurate risk-benefit analyses with less room for bias and misinterpretation of the data. The paper walks through several examples of graphical representations that could provide information that would be helpful to the DMC. This will require investment in resources to develop data visualizations, which can then be reused in future trials.

“In writing this paper, we concluded that several immediate steps can be taken to help DMCs do their jobs more effectively,” Rockhold said. “DMCs will only be equipped to protect patients to the fullest extent when they have complete and easily digestible information to guide their decisions.”

AHA 2019: Machine Learning Not Always the Answer, DCRI Study Finds

November 20, 2019 – A DCRI-led study used two registries to compare three different types of machine learning algorithms with stepwise logistic regression.

Although machine learning is a novel technique that has impressive applications in health care, in some settings, these novel approaches do not improve upon traditional approaches, according to a recent oral abstract DCRI fellow Zak Loring, MD, presented Saturday at the American Heart Association 2019 Scientific Sessions.

The analysis compared three different machine learning techniques—random forests, gradient boosting, and neural networks—with traditional stepwise logistic regression to determine which technique produced the most accurate outcomes model to predict risk for atrial fibrillation patients.

The study team tested the models in two different registries of patients with atrial fibrillation: ORBIT-AF, which includes 23,000 patients, and GARFIELD-AF, which includes 52,000 patients across 35 countries. The team also developed a common data model so that each model could be used across both registries to test external validity.  This is important, Loring said, because often machine learning algorithms are powered for to be highly predictive in one specific patient population.

Zak Loring, MD“Some machine learning algorithms yield impressive results, but may not yield the same results when applied outside the original sample,” Loring said. “Often we build algorithms in clean clinical trial datasets, but when we apply it outside that setting to a wider population that would not have been eligible for the clinical trial, we see weaker performance. It is important to account for generalizability when building these algorithms.”

In comparing the machine learning models to the logistic regression model, the team examined two other measures in addition to external validity: discrimination capacity and calibration. In discrimination capacity, the machine learning method performed as well or slightly worse than traditional regression; in calibration, machine learning performed worse.

In addition, the traditional regression used structured data elements like case report forms, a positive in this scenario because it makes for an interpretable model in which clinicians can identify risk factors.

“One major complaint associated with machine learning models is that they can sometimes be a bit of a black box,” Loring said. “That is, even if they can accurately predict risk, they can’t tell you why that risk is present.”

Loring added that these results show that despite the promise of machine learning, there are likely tasks that are better suited for older techniques. One area that warrants more discussion is the structure of registries. In order to fully harness the power of machine learning, it might benefit researchers to build registries with fewer binary variables and more continuous data.

Other DCRI contributors to this analysis include Jonathan Piccini, MD, MHS; David Carlson, PhD; Eric Peterson, MD, MPH, and former DCRI statistician Karen Pieper, MS.

AHA 2019: Data Highlight Differences in Discrimination of Noninvasive CAD Testing

November 18, 2019 – A new analysis of a DCRI study revealed that younger patients and older patients may need to undergo different types of testing for coronary artery disease in order to more accurately predict risk.

In middle-aged patients with stable symptoms suggestive of coronary artery disease (CAD), anatomic testing with coronary CT angiography (CTA) provided better prediction of risk, also known as prognostic discrimination.

Angela Lowenstern, MD

In contrast, functional (stress) testing provided better prognostic discrimination for older members of this patient population, according to a new analysis of the DCRI-led PROMISE study presented Monday by DCRI fellow Angela Lowenstern, MD, at the American Heart Association Scientific Sessions 2019 in Philadelphia.

“This study indicates that in patients with stable symptoms suggestive of CAD, there are important differences in presentation, test results, and prognostic capabilities of noninvasive testing across age,” Lowenstern said. “Specifically, coronary CTA offers additional risk stratification information for patients aged 45-64, with stress testing results associated with risk for cardiovascular death or myocardial infarction among patients 65 and above. These results support further exploration of age-specific approaches to the noninvasive evaluation of CAD.”

Suspected CAD is one of the most common, potentially life-threatening diagnostic problems encountered by clinicians. As many as five million patients with chest pain undergo noninvasive tests each year, with the goal of confirming the diagnosis and providing information about future risk.

Lowenstern was lead author of the AHA poster, titled “Differences in the Non-Invasive Evaluation for Coronary Artery Disease and Its Prognostic Implications by Patient Age: An Evaluation of the PROMISE Trial.” Other DCRI contributors were Karen Alexander, MD; C. Larry Hill, PhD; Brooke Alhanti, PhD; Michael Nanna, MD; Rajendra Mehta, MD; and Pamela Douglas, MD. The results were published simultaneously in JAMA Cardiology, with Lowenstern as lead author, and the same DCRI contributors.

Sponsored by Duke in collaboration with the National Heart Lung and Blood Institute (NHLBI), the PROMISE study was a prospective, randomized trial comparing the effectiveness of two initial diagnostic strategies—coronary computed tomographic angiography or functional testing—in patients with symptoms suggestive of CAD from 193 North American sites. A total of 8,966 patients were randomized to undergo testing and had interpretable results. The main outcome measure was a composite of cardiovascular death and myocardial infarction over a median follow-up of 25 months.

“Our findings indicate that there is no ‘one size fits all’ diagnostic strategy for patients with suspected coronary artery disease,” said Pamela Douglas, MD, PROMISE principal investigator and the senior author of the JAMA Cardiology publication. “Instead, physicians need to personalize imaging decisions by pursuing the best test for each individual patient after taking into consideration the growing body of data regarding imaging outcomes.”

AHA 2019: Stent Thrombosis is Rare but Serious in Patients with AF and Recent PCI

November 16, 2019 – Rates of stent thrombosis were lowest in patients treated with apixaban rather than a vitamin K antagonist (VKA), such as warfarin, and with aspirin rather than placebo.

Stent thrombosis occurs in less than 1 percent of patients with atrial fibrillation (AF) in the six months after percutaneous coronary intervention (PCI), according to a new analysis of the results from the DCRI-led AUGUSTUS trial.

The analysis also found that rates of stent thrombosis are numerically lower in patients treated with apixaban compared with a vitamin K antagonist (VKA), such as warfarin, and also with aspirin rather than placebo.

Renato LopesThe analysis was presented by the DCRI’s Renato Lopes, MD, PhD, (pictured), principal investigator of AUGUSTUS, on Saturday at the American Heart Association Scientific Sessions 2019, in Philadelphia, PA.

The serious clinical impact of stent thrombosis was confirmed by the trial, which involved current generation drug-eluting stents. The analysis found that among patients with definite or probable stent thrombosis, on the day of the thrombotic event, 70 percent (21 patients) also experienced myocardial infarction; 53 percent (16) had an urgent revascularization; and 40 percent (12) died. There were clinical consequences for all patients who had a stent thrombosis.

AUGUSTUS is an international, multicenter randomized trial designed to compare apixaban with vitamin K antagonists and aspirin with placebo. The trial enrolled patients with AF who develop acute coronary syndrome (ACS) and/or undergo PCI and are receiving a P2Y12 inhibitor antiplatelet drug, such as clopidogrel, prasugrel or ticagrelor. A total of 3,498 patients underwent PCI with stenting during their qualifying clinical event and were at risk for stent thrombosis. Overall, there were 57 stent thrombosis events over six months, of which 20 were definite, 10 probable, and 27 possible. Stent thrombosis was adjudicated by a clinical events committee blinded to randomized treatment allocation and classified according to the Academic Research Consortium. The DCRI’s Clinical Events Classification (CEC) group was responsible for the entire adjudication process of the AUGUSTUS trial.

Lopes was lead author of the AHA presentation, titled, “Stent Thrombosis After Percutaneous Coronary Intervention Among Patients With Atrial Fibrillation Treated With Apixaban or Aspirin: Insights From the AUGUSTUS Trial.” Other DCRI authors of the AHA presentation were Daniel Wojdyla, MS; Christopher Granger, MD; and John Alexander, MD, MHS.

The data were published simultaneously in the journal Circulation. In addition to Lopes, Granger, and Alexander, the DCRI’s Laine Thomas, PhD, contributed to the paper.

“Our study provides important insights about the duration of aspirin therapy after PCI in patients with atrial fibrillation,” Lopes said. “For the majority of patients, the AUGUSTUS data support the use of apixaban and a P2Y12 inhibitor without aspirin during the first six months after PCI, based on the almost two-fold increase in bleeding with aspirin use. It is important to keep in mind that almost all patients used aspirin for the initial days after the PCI—on average for six days—before stopping aspirin therapy.”

“However, in patients with a high risk of stent thrombosis and an acceptable risk of bleeding, using aspirin up to 30 days after PCI should be considered, rather than discontinuing aspirin therapy around the time of hospital discharge. Further studies are warranted to identify the patients who might benefit most from this strategy,” said Lopes.

Bristol-Myers Squibb and Pfizer provided funds for the AUGUSTUS study.

DCRI Contributes to Important Results Presented at AHA 2019

November 16, 2019 –The DCRI served as the statistical and data coordinating center for ISCHEMIA, a late-breaking clinical trial that indicated invasive heart procedures may not reduce the chance of experiencing a major, disease-related event for patients with severe but stable heart disease.

The DCRI played an important role as the statistical and data coordinating center for a late-breaking clinical trial presented today at the American Heart Association’s Scientific Sessions 2019.

Results from ISCHEMIA, which were shared today in Philadelphia via four presentations, indicate that invasive heart procedures may not result in lower rates of major, disease-related events for patients with severe but stable heart disease.

DCRI faculty Sean O’Brien, PhD and Karen Alexander, MD, served as co-principal investigators for the statistical and data coordinating center, participating in all of the data structure and cleaning efforts, as well as data analysis and project oversight. The DCRI’s Frank Rockhold, PhD, also supported statistical work on the trial. Data analysis for the data safety monitoring board was provided by Vanderbilt University’s Frank Harrell, PhD.

The DCRI’s Daniel Mark, MD, oversaw the quality of life outcome assessments, in partnership with John Spertus, MD, at Mid-America Heart Institute.

ISCHEMIA, funded by the NIH’s Heart, Lung, and Blood Institute, sought to determine the most effective course of treatment for patients with ischemia, a chronic, symptomatic condition that is characterized by reduced blood flow to the heart muscle. All patients enrolled in the trial received medication and lifestyle advice, but half of patients underwent routine, invasive procedures—such as stent implants or bypass surgery—while the other half did not. Because intervention can be both risky and costly, the goal of ISCHEMIA was to ascertain whether intervention led to improved outcomes for this group of patients.

Trial results showed that patients who received invasive therapy saw no reduction in five disease-related events when compared to patients who received only medications and lifestyle advice. The five events measured were cardiovascular death, heart attack, hospitalization for unstable angina, hospitalization for heart failure, and resuscitation after cardiac arrest.

However, for patients with symptoms of angina, or chest pain, invasive treatments resulted in improved long-term symptom relief and better quality of life.

To learn more about ISCHEMIA and its results, read the news release.

AHA 2019: Type 2 Myocardial Infarction Results in Higher Risk Than Type 1

November 16, 2019 – Patients who experienced Type 2 myocardial infarction were older and more likely to have comorbidities and risk factors than those who experienced Type 1.

Patients who experience Type 2 myocardial infarction are at higher risk for additional cardiovascular events and death than patients who experience Type 1 myocardial infarction (MI), according to a new analysis from the DCRI.

Chiara Melloni, MDThe analysis, which the DCRI’s Chiara Melloni, MD, presented as an oral abstract Saturday at the American Heart Association Scientific Sessions 2019 in Philadelphia, examined data from three completed DCRI-led trials to shed new light on the differences between patients who experience Type 1 MI and those who experience Type 2 MI.

All three trials—TRACER, which involved patients with acute coronary syndrome; EUCLID, which studied peripheral artery disease; and EXSCEL, which examined patients with Type 2 diabetes—had been adjudicated by the DCRI’s Clinical Events Classification (CEC) group, for which Melloni acts as a faculty adjudicator. This allowed the study team to have access to all the cardiovascular events that had been reported and adjudicated in the three trials and stored in the CEC databases.

Although Type 2 MI was initially defined in 2007, it remains difficult to diagnose because of the heterogeneity of the patient population that experiences it, as well as the different cardiac markers, assays, and cut-off used, said Melloni. While Type 1 MI is caused by a plaque rupture and has clear symptoms, Type 2 MI, which is characterized by a mismatch between oxygen demand and supply in the coronary vessel, is rarer and can be associated with many different comorbidities.

The analysis examined and compared baseline characteristics of patients enrolled in their respective trials based on the type of MI they experienced after inclusion in the study. Patients who experienced a Type 2 MI during the trial tended to be older and were more likely to have comorbidities and CV risk factors—overall, the Type 2 MI group was a sicker population than the Type 1 group.

The study team also examined outcomes of patients who experienced an MI during a trial. When followed from a year after their initial MI, patients with Type 2 MI were at a higher risk for subsequent MIs or death than their Type 1 counterparts.

One of the key messages of the analysis, Melloni said, was that the results held true regardless of the level of the cardiac troponin released in the blood. The rise and fall of troponin levels are used to ascertain whether a patient has experienced MI, and the peak level of troponin was collected for each patient. Even if patients with Type 2 MI experienced relatively lower levels of troponin leak during the time of their first MI compared with type 1 MI patients, they were at higher risk for negative outcomes than patients with Type 1 who had the same levels of troponin leak.

Other DCRI contributors to this analysis include Karen Alexander, MD; Angie Wu, MS; Schuyler Jones, MD; Rajendra Mehta, MD; David Kong, MD; Thomas Povsic, MD; Manesh Patel, MD; Sana Al-Khatib, MD; and Renato Lopes, MD, PhD. Matt Wilson and Marsha Marquess, who both work on the CEC team, were also instrumental in helping the study team identify which trials could provide the most suitable datasets to perform this analysis.

DCRI Teams With American Heart Association to Conduct Pragmatic Clinical Trials and Pursue Implementation Science

November 15, 2019 – The innovative collaboration will enable real-world data from American Heart Association’s Get With the Guidelines programs to power future clinical research and improve patient outcomes.

A new collaboration building on the strengths of the American Heart Association and the Duke Clinical Research Institute (DCRI) in cardiovascular research and data science will deliver insights to enhance quality of treatment for cardiovascular disease and improve patient outcomes.

The American Heart Association, the leading voluntary health organization devoted to a world of longer, healthier lives, collects patient data from more than 2,000 hospitals in its Get With The Guidelines (GWTG) quality improvement programs. The Association and the DCRI will collaborate to design and conduct pragmatic randomized clinical trials in existing real-world nationwide registries. In addition to pragmatic trials, the strategic alliance will also investigate implementation of best-practices to treat cardiovascular illness, improve outcomes, and reduce suffering.

The DCRI is a leader in pragmatic approaches in clinical research. The DCRI, in collaboration with PCORnet, pioneered the ADAPTABLE study, which recently completed enrollment of 15,000 patients using real-world data from electronic health records.

Jonathan Piccini, MD“We are delighted to expand our collaboration and research initiatives with the American Heart Association. Our experience in conducting pragmatic trials makes the DCRI a logical partner for applying pragmatic clinical design approaches with Association’s data-rich Get With The Guidelines program. By uniting our experience and leadership in clinical trials and operational expertise with the Association’s repository and experience in quality improvement, together we can create new clinical evidence and glean insights that will advance cardiovascular health, inform treatment guidelines, and accelerate the adoption of scientific discoveries into clinical practice,” said Jonathan Piccini, M.D., MHS, the principal investigator of the GWTG analytic center at the DCRI.

“The role of real-world data and real-world evidence in health care decision making is continuing to grow,” said John Warner, executive vice president for health system affairs at UT Southwestern and American Heart Association volunteer expert.  “This new collaboration with the DCRI will help us to more effectively use our patient-level and hospital-level data to not only inform guideline developments but also generate new and innovative treatment approaches.”

The American Heart Association’s Get With The Guidelines® (GWTG) data registry is composed of five modules focused on various patient conditions including stroke, heart failure, AFib, resuscitation, and coronary artery disease. Each module shares the goal of improving patient care by promoting consistent adherence to the latest scientific treatment guidelines.

“The premise of the data registry and the quality improvement programs that follow is that when medical professionals apply the most up-to-date evidence-based treatment guidelines, patient outcomes improve,” said Mariell Jessup, chief science and medical officer for the American Heart Association. “Combining the reach of the American Heart Association’s connection to more than 2,000 hospitals and millions of patient data records with the real-world data research experience of the DCRI brings tremendous potential for upcoming pragmatic clinical trials that will result in healthier patients.”

To read the original news release, visit the American Heart Association website.

DCRI to Partner With Amgen on Large-Scale Registry

November 15, 2019 – By enrolling 8,500 high-risk patients with a recent atherosclerotic cardiovascular disease event, cvMOBIUS will be the first large-scale registry to evaluate real-world lipid management and the effectiveness of PCSK9 inhibitors.

Amgen (NASDAQ:AMGN) in collaboration with the Duke Clinical Research Institute (DCRI) today announced plans to initiate the Cardiovascular Multi-dimensional Observational Investigation of the Use of PCSK9 inhibitors (cvMOBIUS) study—the first large-scale real-world study to assess lipid management and the impact of PCSK9 inhibitors on cardiovascular (CV) outcomes in clinical practice. While there is strong evidence demonstrating the efficacy of PCSK9 inhibitors from various randomized clinical trial studies, there is less information on the effectiveness of these medicines on cardiovascular outcomes in real-world practice.

The cvMOBIUS study will be conducted across the U.S. and Canada and will begin patient enrollment this month. A prospective observational registry of 8,500 adults eligible for treatment with a PCSK9 inhibitor will be followed for five years. In parallel, an electronic health record (EHR)-based registry will follow a broader population of adults hospitalized with atherosclerotic cardiovascular disease (ASCVD) at participating sites.

Ann Marie Navar, MD, PhD“Cardiovascular disease is one of the most significant public health issues facing our country today. Gathering robust, large-scale data from diverse patients will better inform lipid management and help decrease the burden of cardiovascular disease in these high-risk patients,” said Ann Marie Navar, M.D., Ph.D., assistant professor of medicine at the Duke University School of Medicine and member of the DCRI. “The clinical evidence supporting the efficacy and safety of PCSK9 inhibitors in patients with cardiovascular disease is well established, but we still have a lot to learn about the benefits of these medicines in the real world.”

Patients who have experienced a recent ASCVD event, including a myocardial infarction (MI), are at higher risk of experiencing another CV event, especially within the first year after.1,2 Lipid lowering is one of the key approaches for reducing a patient’s risk for secondary events.1 Based on large randomized trials, major professional cardiology societies, including the American Heart Association and the American College of Cardiology, acknowledge that lower is better when it comes to low density lipoprotein cholesterol (LDL-C) management in patients who have experienced an MI and other ASCVD events.3

“LDL-C is one of the most important modifiable risk factors for cardiovascular disease, so lipid Eric Peterson, MD, MPHmanagement is an essential element in reducing future CV events and improving clinical outcomes for high-risk patients,” said Eric D. Peterson, M.D., MPH, distinguished professor of medicine at the Duke University School of Medicine and member of the DCRI. “This large registry will examine how care is being delivered in clinical practice to patients—whether we are using the right medicines, whether we are reaching guideline-based LDL-C targets, and the degree to which achieving these goals impacts outcomes in real-world practice.”

“The cvMOBIUS study is important because it is one of the few instances that researchers will utilize data pulled directly from hospitals’ EHR systems for research. This should help set the stage for future big data analyses and pragmatic clinical trials,” said Dr. Peterson.

Two large randomized outcomes trials, including the Repatha® (evolocumab) cardiovascular outcomes (FOURIER) study, have demonstrated that innovative therapies like PCSK9 inhibitors lower LDL-C levels and can reduce the risk of heart attacks in high-risk patients with established cardiovascular disease. Additionally, the VESALIUS-CV trial, initiated in March 2019, is an ongoing randomized outcomes trial, designed to evaluate the long-term effects of Repatha in high-risk cardiovascular disease (CVD) patients without a prior heart attack or stroke. The study will be the first to investigate long-term outcomes in this population with Repatha for a minimum of four years.

“Amgen is committed to building a vast body of evidence for Repatha—clinical trial and real-world effectiveness data sets—to advance the knowledge and treatment of cardiovascular disease,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “This study will generate valuable real-world evidence to help us demonstrate that PCSK9 inhibitors, like Repatha, are an important treatment option for very high-risk patients and can help prevent recurrent cardiovascular events in the real world.”

Drs. Navar and Peterson are co-primary investigators of the study.


  1. Yusuf S, et al. Lancet. 2004;364:937-952. 5. Ference BA, et al. EHJ. 2017;38:2459-2472.
  2. Kuklina, EV. Centers for Disease Control and Prevention. Vital signs: prevalence, treatment, and control of high levels of low-density lipoprotein cholesterol. United States, 1999–2002 and 2005–2008. MMWR. 2011;60(4):109–14.
  3. Grundy SM, et al. JACC. 2018; 1-80.
  4. Repatha Prescribing Information; Amgen, Thousand Oaks, CA, 2018.
  5. World Health Organization. Cardiovascular diseases (CVDs) fact sheet.

DCRI’s Arrhythmia Core Lab Looks to Future in Wearables Work

November 12, 2019 – The Arrhythmia Core Lab is applying its expertise in evaluation and adjudication of electrograms and electrocardiograms to new studies that involve wearable devices.

The American Heart Association’s (AHA) Scientific Sessions are quickly approaching, bringing with it renewed excitement about how wearable technologies can deliver new insights in health care.

Take, for example, new findings slated to be presented from the Apple Heart Study that will share how Apple Watches can detect other clinically important arrhythmias in addition to atrial fibrillation. Results such as these bring new opportunities to make patient care more convenient, identify and diagnose more clinical events, and ultimately improve patient outcomes.

The DCRI’s Arrhythmia Core Lab (ACL) is capitalizing on this momentum behind wearable devices and their potential to further deliver on the DCRI’s mission of pursuing innovative clinical research that improves patient care around the world.

“The ACL is well-poised to build on its long tradition of high-quality work in heart rhythm tracing and device trials,” said the DCRI’s Sean Pokorney, MD, MBA, director of the ACL. “Our work as the core for APPRAISE ATP, the world’s largest randomized clinical trial of implantable cardioverter defibrillator therapy, is evidence of our leadership in working with devices, and we look forward to making an even greater impact in the wearables space.”

The ACL, part of the DCRI’s Clinical Events Classification group, is focused on the evaluation, adjudication, and validation of electrocardiograph and electrogram review. To complete this work, the ACL draws on its members’ extensive experience in clinical cardiac electrophysiology, including ambulatory heart rhythm monitoring and device-based electrogram evaluation, as well as clinical arrhythmia management. Beyond their clinical experience, the ACL adjudicators and clinicians are also leading experts in the design and execution of clinical trials and outcomes research.

The ACL is accustomed to making new discoveries by exploring novel and innovative research areas. It served as the core laboratory for GENETIC-AF, the first pharmacogenetic-guided trial of beta-blocker therapy for the prevention of recurrent atrial fibrillation in patients with heart failure. In another first, the ACL served as the core lab for CAT-HF, the first study of noninvasive ventilation in patients with heart failure and sleep apnea.

The ACL is continuously pursuing new methods to expand its knowledge base. For example, the group’s leaders are exploring ways to incorporate machine learning into their processes. DCRI fellow Zak Loring, MD, explained that machine learning could be used to extract patient-level data from electrocardiograms, which can then be used to build deeper phenotypes of arrhythmias or prediction tools for things like the best site for catheter ablation. These new techniques could enable the ACL to better find the best therapies for each individual patient. In addition, given today’s record number of startups pursuing wearables, the ACL is also considering strategic partnerships that will enable it to remain at the forefront of heart rhythm tracing and event adjudication.

“The ACL’s experience ranges from pre-clinical work and randomized clinical trials to post-marketing Jonathan Piccini, MDtrials and observational studies,” said the DCRI’s Jonathan Piccini, MD, MHS, who also works with the ACL. “No matter what the study calls for, we are prepared to innovate and find efficiencies, and we are excited to pursue more of this work with wearables.”

Pokorney and Piccini will both be presenting at the 2019 AHA Scientific Sessions. Pokorney will present results from a late-breaking clinical trial and participate on a panel called “Device Troubleshooting.” Piccini will give a talk on controversies within the new guidelines for treatment of atrial fibrillation. Read more about their presentations and DCRI’s presence at the conference.

2019 Annual Report: 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 and studies 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.

The past year has brought challenges and change, and also a deeply renewed commitment to our mission throughout the DCRI and across the Duke system. We completed a comprehensive strategic planning effort and launched transformation initiatives aimed at revitalizing our core offerings and advancing new ways of conducting clinical research. The DCRI is an undisputed leader in the areas of using pragmatic approaches and real-world data to improve clinical trial design—the future of clinical research. Our overarching goal is to ensure the DCRI remains distinct in its academic and operational expertise and its approaches—for the benefit of our sponsors, partners, collaborators, and the patients we serve. As expected, we opened a search for a new executive director. In the coming year, I am excited to be able to hand the reins of an invigorated and future-focused organization to a new leader.

I am honored to have led the DCRI. The progress we have made is due to so many—a sincere commitment to improvement from the DCRI operational teams and support from the Duke School of Medicine and my colleagues, both at the DCRI and the Department of Population Health Sciences.

I look forward to an exciting year ahead and many years of growth and contribution as the DCRI continues to achieve its mission to improve the care of patients around the world through innovative clinical research.

Lesley H. Curtis, PhD
Chair and Professor
Department of Population Health Sciences
Interim Executive Director, Duke Clinical Research Institute
Duke University School of Medicine


This article originally appeared in the DCRI’s 2018-2019 Annual Report. View more articles from this publication.