Duke partners with Vivli to engage in a new era of open science

July 19, 2018 – The DCRI’s Frank Rockhold, PhD, will serve on the steering committee for the new data sharing and analytics platform.

Adrian HernandezDuke University School of Medicine has announced a partnership with Vivli, a nonprofit organization that today launched a new data sharing and analytics platform. With the launch of the Vivli platform, researchers worldwide will have a simple yet secure way to discover, share and analyze data from clinical trials, regardless of who sponsored the research or where the research took place.  Vivli, Duke and other partners hope that sharing data from clinical trials will expedite the development of cures and treatments for diabetes, Alzheimer’s, malaria and other diseases.

“Duke University School of Medicine is pleased to partner with the Vivli organization to foster the principles of open science and data access from clinical studies,” said Adrian Hernandez, MD, vice dean of clinical research in the School of Medicine. “At Duke, we are committed to developing research polices, platforms and methods to provide appropriate access to research information, with the ultimate goal of expediting the development of new treatments to improve the health of patients around the world.”

Hernandez added that during fiscal year 2017, Duke led 494 clinical trials that were conducted locally.

The new platform allows researchers to store and share clinical trial data across all diseases, nations and research entities. Vivli also allows researchers to freely combine and analyze data from multiple trials using state of the art tools. This means researchers can validate research findings—from confirming a treatment’s safety to identifying side effects—and avoid duplicative studies, thus reducing costs and shielding research participants from unnecessary risks. The data can also be combined to ask new research questions, such as how a disease evolves over time, and gain information to inform the design of future studies.

Frank Rockhold, PhD, professor of biostatistics and bioinformatics at Duke University School of Medicine and a member of the DCRI, has worked with Vivli for more than four years as scientific advisor and as a member of its leadership team.  As part of this new partnership, he will be the representative for Duke on the Vivli steering committee and will continue as a senior academic advisor.

“The partnership between Duke and Vivli will combine the academic trial and data disclosure expertise of the Duke University School of Medicine with the passion and experience of Vivli and its other partners to provide a huge step forward in making clinical trial data available to researchers in a way that recognizes and respects the rights of patients and the contributions of the trialists,” said Rockhold.

The Vivli platform, powered by Microsoft, was built with grants from the Doris Duke Charitable Foundation, the Laura and John Arnold Foundation and the Leona M. and Harry B. Helmsley Charitable Trust.

Julius Wilder receives Clinical, Translational, and Outcomes Research Award from AASLD

July 11, 2018 -The award is presented to young researchers studying liver disease.

The DCRI’s Julius Wilder, MD, PhD, has received a Clinical, Translational, and Outcomes Research Award from the American Association for the Study of Liver Diseases (AASLD).

The award, which totals $200,000 over two years, is intended to foster career development for individuals performing clinical, translational, or outcomes research in a liver-related area and who have shown commitment to excellence at an early stage of their research study.

Wilder’s award will fund a project to contextualize why poor people, people of color, and people whose native language is not English are at a disadvantage for being listed for liver transplantation. The data generated by Wilder’s study will result in the creation of a intervention project to help patients with end stage liver disease circumnavigate perceived barriers to listing for transplantation.

“Once an individual has end stage liver disease, transplantation is their best option,” Wilder said. “Many lives are lost every year because individuals were unable to gain access to this precious resource. This award will allow me to identify barriers and create solutions for people with end stage liver disease who require a liver transplantation.”

Wilder earned his MD and PhD at Duke and was a DCRI Fellow. He has been a DCRI faculty member since 2016.

The DCRI welcomes new faculty members

July 10, 2018 – The seven new faculty members come from the departments of Pediatrics, Cardiology, Neurology, and others.

Stephen J. Balevic, MD, MHS

Stephen J. Balevic, MD, MHS, joined the DCRI on July 1 as an assistant professor in the departments of Pediatrics and Internal Medicine at Duke University Medical Center. He was most recently an adult and pediatric rheumatology fellow at Duke University, and a pediatric clinical research fellow at the DCRI.

Balevic completed medical school at the Marshall University School of Medicine in his home state of West Virginia, and a combined internal medicine and pediatric residency at the Medical University of South Carolina. He obtained his MHS degree with a concentration in clinical pharmacology through the Clinical Research Training Program at Duke University/UNC School of Pharmacy, and his bachelor’s degree from UNC-Chapel Hill.

Balevic’s research interests are in clinical pharmacology, precision medicine, and clinical trials.

Satasuk Joy Bhosai, MD, MPH

Satasuk Joy Bhosai Satasuk Joy Bhosai, MD, MPH, joined the DCRI on July 1 as a Hospitalist Physician with Duke Health and a member of the executive leadership team for the DCRI Innovations group. Most recently she completed her residency at Duke, during which time she completed the Duke Management and Leadership Program. In that program, Bhosai designed multiple health systems leadership initiatives focused on patient safety, quality improvement, and digital innovations.

She earned her medical degree from the University of California, San Francisco, completing the global health pathways program. She holds an MPH degree with a focus in health management from Yale University, School of Public Health and Yale School of Management, as well as bachelor’s degrees in anthropology and neuroscience from Pomona College. She was a Fulbright scholar at the National Cancer Institute/Prince Mahavahiralongkorn Cancer Center in Thailand.

Bhosai’s work addresses gaps in access to high-quality care. Through previous public health work in Africa and Asia, she developed innovations dedicated to improving access to health services. She is the co-founder of ChatrHealth, a software group that specializes in creating patient safety applications for hospitals and providers, which has been supported by large academic centers and the World Bank. Bhosai has worked with Health 2.0, directing the Matchpoint program, which pairs industry leaders with health tech startups.

Michael L. James, MD, FAHA, FNCS

Luke JamesMichael L. (Luke) James, MD, FAHA, FNCS, joined the DCRI as an associate professor of anesthesiology and neurology on April 1. He is also associate director of Duke Clinical Anesthesiology Research Endeavors (CARE), a departmental initiative to further organize clinical research efforts in all areas of anesthesia and perioperative research at Duke University, and associate director of the Duke Brain Injury Translational Research Center.

James joined the Duke faculty in 2006 and has been the Duke principal investigator for multiple large, multi-center intracerebral hemorrhage and brain trauma trials. He has served in the clinical research unit for anesthesiology, as part of the neurocognitive core for the Cardiothoracic Surgical Trials Network, on the Duke IRB, and at Duke’s sister medical school in Singapore.

In addition to maintaining an active clinical practice, in recent years James’s focus has shifted towards clinical research. He and his research collaborators continue to advance translatable therapeutic opportunities into human investigation for acute intracerebral hemorrhage and brain trauma. Their current research focuses on noninvasive measurement of brain temperature and metabolism, systemic effects of acute neurological injury, gonadal hormone modulation of neuroinflammation, and the therapeutic potential of apoE-mimetic peptides.

James has worked to foster long-term multidisciplinary collaboration in all subspecialties that practice neurocritical care. He has served on the Board of Directors of the Society for Neuroscience in Anesthesiology and Critical Care, represent the Neurocritical Care subspecialty at the United Council of Neurological Subspecialties, and played central roles in the Neurocritical Care Society and Society of Critical Care Medicine.

James received his MD degree from Louisiana State University and his bachelor’s degree from Vanderbilt University. He completed residencies in neurology and anesthesiology with fellowships in neurocritical care, neuroanesthesia, and vascular neurology.

Amber J. Oberle, MD

Amber OberleAmber J. Oberle, MD, joined the DCRI as a medical instructor in the Department of Medicine’s Pulmonary, Allergy, and Critical Care division on July 1.

She earned her medical degree from Creighton University School of Medicine in Omaha, NE and completed a residency in internal medicine and a fellowship in pulmonary and critical care medicine at Indiana University. She holds a BS degree in chemistry from Creighton University.

Oberle’s research focuses on asthma and other pulmonary diseases. While at Indiana University, she founded the Adult Asthma Center, dedicated to managing severe asthma and complex airway diseases. Oberle is a member of the American Thoracic Society and the American College of Chest Physicians.


Kishan S. Parikh, MD

Kishan ParikhKishan S. Parikh, MD, joined the DCRI as an assistant professor in the Department of Medicine’s Cardiology division on July 1. He most recently completed a fellowship in Advanced Heart Failure, Mechanical Circulatory Support, and Transplant at Duke University. Prior to that, he was a cardiology fellow at Duke, where he was chief cardiovascular fellow, and a clinical research fellow at the DCRI under the mentorship of Adrian Hernandez and G. Michael Felker. He also pursed additional coursework in clinical pharmacology training at the UNC Eshelman School of Pharmacy during his DCRI fellowship.

He earned his medical degree from Feinberg School of Medicine, Northwestern University and completed his residency in the Department of Medicine, University of Chicago, where he served as chief resident. He holds a bachelor’s degree in biology from Northwestern.

Parikh’s research interests are focused on improving care for pulmonary hypertension and heart failure, and bringing the fields closer to the concept of targeted therapy. More specifically, he aims to integrate the clinical approach to pulmonary hypertension and heart failure with prediction of therapeutic response. He currently serves as co-principal investigator and principal investigator for several Phase I and II trials of investigational agents and mobile health monitoring in pulmonary hypertension, and he led a first-in-man study of invasive hemodynamic monitoring in pulmonary arterial hypertension. He also has studied use of pharmacogenetics in heart failure.

He served on the Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for Peripheral Venous Disease and continues to serve as a Duke Margolis Center for Policy fellow focused on the use of real-world evidence in regulatory decision making. He helped plan and synthesize a report for a recent DCRI Think Tank on heart failure with preserved ejection fraction.

 Kathleen Welsh-Bohmer, PhD

Kathleen Welsh-BohmerKathleen (Kathie) Welsh-Bohmer, PhD, joined the DCRI on May 1 to lead Alzheimer’s disease trials. She is a professor of psychiatry and neurology at Duke University as well as the chief of the Medical Psychology Clinical Professional Unit, the professional home for the more than 200 academic psychologists within the Duke Health system.

Clinically trained as a neuropsychologist, Welsh-Bohmer’s research activities have been focused on developing effective prevention and treatment strategies to delay the onset of cognitive disorders occurring in later life. She was the principal investigator of the Cache County Memory Study, an epidemiological study of an exceptionally long-lived population that established key environmental modifiers affecting Alzheimer’s disease onset and progression.

Since 2006 Welsh-Bohmer has directed the Joseph and Kathleen Bryan Alzheimer’s Center in the Duke Department of Neurology, where she leads a large multidisciplinary team focused on discovering the biological basis of Alzheimer’s disease and developing methods to enhance early diagnosis and speed drug discovery. Since 2011, she has led the neuropsychology scientific operations of a Phase III global clinical trial to delay the onset of Alzheimer’s disease entitled the “TOMMORROW” study.

Welsh-Bohmer joined the Duke University faculty in 1987. She received her PhD and master’s degree from the University of Virginia, postdoctoral specialization in neuropsychology from the University of Iowa, and her bachelor’s degree from Duke. She is board certified by the American Psychological Association in the practice of neuropsychology.

Christina M. Wyatt, MD

Christina M. Wyatt, MD, joined the DCRI as an associate professor in the Department of Medicine’s Nephrology division and an associate director for the DCRI fellowship program on July 1. Prior to joining the DCRI, she was an associate professor in the Department of Medicine, Division of Nephrology, Icahn School of Medicine at Mount Sinai in New York. Since 2017, she served as Associate Chair for Clinical and Translational Research in the Mount Sinai Department of Medicine.

Wyatt earned her medical degree from Duke University School of Medicine. She completed her residency and was chief resident in the Department of Medicine and completed a fellowship in the Division of Nephrology at the Mount Sinai School of Medicine. She also holds an MS degree in biostatistics with a focus on clinical research methods from Columbia University’s Mailman School of Public Health. She received her bachelor’s degree in history from Duke.

Wyatt’s research focuses on nephrology and kidney disease, particularly kidney disease and medication toxicity in patients with or at risk for HIV infection. She has published extensively on these topics and currently serves on the editorial boards of Kidney International and JAIDS. She is a member of numerous scientific working groups and is on the Executive Committee for Kidney Disease: Improving Global Outcomes (KDIGO), an international guidelines organization.​

Rao named as editor of Circulation: Cardiovascular Interventions

June 25, 2018 – Rao was previously the associate editor for the Journal of the American College of Cardiology and the American Heart Journal.

Sunil RaoThe DCRI’s Sunil V. Rao, MD, will become the new editor-in-chief of Circulation: Cardiovascular Interventions, one of 12 American Heart Association (AHA) scientific journals, on July 1.

Circulation: Cardiovascular Interventions, an American Heart Association journal that launched in 2008, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease and vascular disease, with priority placed on original research and on randomized trials and large registry studies that advance clinical practice and patient outcomes.

“I am honored and thrilled to be editor-in-chief for Circulation: Cardiovascular Interventions,” Rao said. “We have a great team that is dedicated to upholding the impeccable research brand of Circulation and making the journal the leading source of impactful interventional science.”

Rao is Professor of Medicine at Duke University Health System, Chief of Cardiology at the Durham Veterans Affairs Health System, and a member of the DCRI. His main research interests deal with pharmacological and interventional therapies for acute coronary syndromes, as well as bleeding and blood transfusion complications among patients with ischemic heart disease. He has led several clinical trials in the interventional cardiology space, and he has published over 200 papers in leading medical journals.

Rao is a former associate editor for the Journal of the American College of Cardiology and the American Heart Journal. In addition, he was the Editor-in-Chief for the ACC CathSAP 5 and will be the meeting chair for the 2019 Society for Cardiovascular Angiography and Interventions Annual Scientific Sessions.

“We are confident that Dr. Rao will bring the highest level of dedication and commitment to excellence in the publication of cardiovascular intervention research,” said Mark Estes, MD, chair of the AHA’s Scientific Publishing Committee and Professor of Medicine at the New England Cardiac Arrhythmia Center at Tufts University School of Medicine.

Health insurance marketplaces offer better decision-making tools, but cost estimates vary widely

June 21, 2018 – A study by DCRI and University of Pennsylvania researchers found that the same health insurance plan considered by the same patient had widely varying total costs on the public and private exchanges.

From November 2016 to January 2017, more than 12 million Americans selected a health insurance plan on the Affordable Care Act’s public marketplaces and many others used federally approved private online exchanges to select a health plan.

In a study published in the Journal of General Internal Medicine, the DCRI’s Charlene Wong, MD, MSHP, and colleagues from the University of Pennsylvania evaluated consumer-facing web sites to evaluate how the choice environments and availability of decision tools, comparing these resources with those available in the previous year’s open enrollment period. These tools include decision aids like estimators for total out-of-pocket costs, provider lookup, drug lookup and pop-up definitions of insurance and health terminology.

One of the most influential tools for consumers may be those that offer total cost estimates that integrate the premium cost with deductibles and estimates of copays or coinsurance that are based on the consumer’s anticipated use of health care in the upcoming year. However, in the 2016-2017 open enrollment period, the research team found that the same health insurance plan considered by the same patient had widely varying total costs on the public and private exchanges – an average of $1,526 for the same plan in each state reviewed.

“Decision support tools are valuable, but only if consumers understand them and if they are accurate,” Wong said. “We are encouraged that the exchange sites we reviewed all have provider lookup mechanisms – an important factor for continuity of care and avoiding high out-of-network charges – but many sites still lack information on drug formularies and quality ratings. Without accurate information on what drugs are covered under a given plan, patients will have difficulty assessing how much they may owe for prescriptions under a new plan.”

The team also found that the proportion of exchanges presenting plans in order of premium cost has decreased, while best fit and total cost estimate options have increased. Wong and her colleagues previously found that the order in which plans are presented can influence consumer choice. For 2016-2017, the team found that some private exchanges are making explicit and implicit plan recommendations (for example by flagging a plan as “recommended” or displaying certain plans in a separate display area on the page). More research is needed on how the features of the choice environment influence consumer plan choices and whether they accurately address consumer needs in the complex decision-making process of selecting a health plan.

NICHD renews $96 million federal contract for Pediatric Trials Network

June 19, 2018 – The award will fund the network for an additional eight years.

The DCRI’s Pediatric Trials Network (PTN) team has been awarded $96 million by the National Institute of Child Health and Human Development (NICHD) to design and lead pediatric trials over the next eight years.

Daniel Benjamin

An alliance of several of the country’s preeminent pediatric experts and medical centers, the PTN was founded in 2010 with a $95 million grant from the National Institutes of Health (NIH) and conducts the majority of the DCRI’s pediatric clinical trials, studying the formulation, dosing, efficacy, and safety of off-patent drugs and medical devices used in pediatric patients.

“Over the last eight years, we have been able to conduct 26 clinical trials in 13 different therapeutic areas enrolling over 8,000 children, which is more than triple the scope of work that was outlined in the initial NIH contract,” said Daniel Benjamin, Jr., MD, PhD, principal investigator and chair of the PTN.

Benjamin was the original awardee of the NIH contract in 2010. He and the PTN’s program manager, Gary Furda, helped secure the second award for an additional eight years. Additional DCDRI faculty supporting the contract include Christoph Hornik, MD; Kanecia Zimmerman, MD; and Michael Cohen-Wolkowiez, MD, PhD.

“Danny and his primary supporters on the faculty side are outstanding in what they do and their passion for improving the health of children is unmeasured,” said Taylor Nguyen, a senior business development associate at Duke who was part of the grant-writing group. “The incredible results that the PTN team has produced over the course of the last eight years are largely due to their commitment and passion and how they go above and beyond in the work they do.”

“In the first eight years of the PTN, we were able to transform neonatal and obesity trials,” Benjamin said. “Over the next eight, we will have people rethink the way drug studies are done for breastfeeding women and mental health for children.”

Benjamin intends for the PTN to lead the way in revolutionizing the way clinical trials are conducted in children.

“We will continue designing larger trials and make these large trials more efficient,” he said. “With all the operational excellence at the DCRI, the junior and mid-career faculty, and our very determined staff at the PTN sites working together round the clock in various capacities and doing exceptional work for the network, no goal is big enough.”

African-Americans less likely to receive statin therapy at recommended levels, study finds

June 13, 2018 – Researchers used data from the PALM registry to compare treatment of African-American and white patients.

African-Americans are less likely to receive statin therapy at levels recommended by current guidelines, according to a study by DCRI researchers published this week in JAMA Cardiology.

Michael NannaDemographics, clinical characteristics, socioeconomic status, patient beliefs, and clinician factors all contributed to this discrepancy, the researchers said.

African-American patients are at higher risk for atherosclerotic cardiovascular disease, yet previous research has shown that African-Americans are less likely to receive statin therapy when indicated compared with white individuals. The reasons for these differences are not well understood.

In this study, led by Duke Cardiology Fellow Michael Nanna, MD, researchers sought to better understand the treatment patterns of African-Americans receiving statin therapy. To do so, they examined data from the Patient and Provider Assessment of Lipid Management (PALM) registry. PALM is a repository of patients from across the United States with cardiovascular risk factors warranting consideration of lipid-lowering therapies, as well as patients already on statin therapy.

Using the PALM registry, Nanna and his colleagues identified 5,689 patients from 138 health care practices who were eligible for statin therapy. Of these patients, 806 were African-American (14.2 percent) and 4,883 were white (85.8 percent). Among those treated, just 269 African-American patients received statin therapy at the recommended level (33.3 percent), compared to 2,145 white patients (43.9 percent). The median low-density lipoprotein cholesterol levels of patients receiving treatment were higher among African-American than white individuals.

The researchers found that African-American patients were less likely than white patients to believe statins were safe (36.2 percent vs. 57.3 percent) or effective (70.0 percent vs. 74.4 percent). African-Americans were also less likely to trust their clinician (82.3 percent vs. 93.8 percent).

These differing beliefs about statins, cholesterol, and medical care may contribute to ongoing disparities in statin therapy, the researchers noted.

“What we found is that this is a complex issue,” Nanna said. “The treatment differences are partially explained by clinical factors but socioeconomic, patient belief and provider characteristics all contributed as well. What this means is that in order to identify how to improve our treatment, we will need to take a multi-dimensional approach.

“Ultimately, we need to build trust with our patients, be consistent in our application of guideline-recommendations and educate both our clinicians and patients on the appropriate therapies for risk reduction.”

In addition to Nanna, other Duke authors included the DCRI’s Ann Marie Navar, MD, PhD; Pearl Zakroysky, MPH; Qun Xiang, MS; Tracy Y.Wang, MD, MHS, MSc; and Eric D. Peterson, MD, MPH.

State Medicaid programs test whether offering incentives increases adoption of healthy behaviors

June 11, 2018 – A new report found early signs of success in incentive programs for healthy behaviors.

State efforts to help Medicaid beneficiaries engage in specific health behaviors show early signs of success, according to a new report. The report, which discovered 18 state Medicaid programs and nearly all Medicaid managed care plans are offering incentives for health behaviors, found that programs targeting preventive services and smoking cessation sparked the most initial success. The analysis was developed by researchers at the Duke-Margolis Center for Health Policy with funding from the Robert Wood Johnson Foundation. The DCRI’s Charlene Wong, MD, was one of the report’s authors.

The programs provide incentives for Medicaid recipients to lose weight, control diabetes, manage blood pressure, attend pregnancy visits, and more. A range of incentives are used, including gift cards, reduced insurance premiums, and monetary penalties. Among the report’s findings:

  • A Wisconsin program saw 22 percent of Medicaid beneficiaries quit smoking after receiving both financial incentives and counseling, compared to quit rates of 14 percent for smokers who only received counseling.
  • Similarly, an Idaho program saw their “well-child visit” rates jump from 40 percent to 66 percent after incentives were offered.

Overall, researchers found substantial variation in the results of the efforts, and limited and mixed evidence on whether the programs are linked to improvements in people’s health. In addition, while states and Medicaid managed care plans devoted significant effort to advertise and inform beneficiaries about the programs, only two states out of 10 participating in a related federal grant program met their enrollment targets. The report considers further administrative challenges for the programs, including higher than expected costs for administration and data systems.

Researchers note that the long-term viability of these incentive programs will depend on more evidence about the effectiveness of these incentives on long-term health outcomes, optimal program design, and the impact on vulnerable populations.

Curtis and Tcheng named to NESTcc data quality subcommittee

June 7, 2018 – The subcommittee will develop data quality standards for NESTcc partners and make recommendations for their implementation.

The DCRI’s Lesley Curtis, PhD, and James Tcheng, MD, have been named to the Data Quality Subcommittee of the National Evaluation System for health Technology Coordinating Center (NESTcc).

Lesley CurtisThe Data Quality Subcommittee and a Methods Subcommittee will develop data quality and methodological standards for the NESTcc Network Collaborators, the organizations partnering with NESTcc to generate and analyze real-world data. The subcommittees will also design processes for demonstrating conformance to the standards and make recommendations for their implementation. These standards will build upon existing bodies of work and leverage subcommittee members’ knowledge and experience from similar initiatives, including PCORnet, Sentinel, and MDEpiNet.

“Our Data Quality and Methods Subcommittees are comprised of national leaders in the areas of data quality and methods standards. Establishing these subcommittees is an essential step in ensuring confidence in the quality of medical device real-world data and real-world evidence generated by partnerships with NESTcc,” said Rachael L. Fleurence, PhD, Executive Director of NESTcc. “We look forward to their counsel and collaboration as NESTcc prepares to launch its first set of industry test cases to demonstrate the functionality of the NESTcc Data Network and we prepare to open the NESTcc Front Door for public inquiries for collaborating with the NESTcc Data Network.”

Curtis, who is the co-lead of the PCORnet Distributed Research Network Operations Center and previously co-led the Data Core for FDA’s Mini-Sentinel Initiative, will chair the Data Quality Subcommittee.

Data Quality Subcommittee Members

  • Jeffrey Brown, PhD, Harvard Pilgrim HealthCare Institute/ Harvard Medical School
  • Lesley Curtis, PhD, MS, Duke University School of Medicine
  • Sarah Horn, PhD, Medtronic
  • John Laschinger, MD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health (CDRH)/ODE/DCD/SHDB
  • Aaron Lottes, PhD, Cook Research Incorporated
  • Keith Marsolo, PhD, Cincinnati Children’s Hospital Medical Center
  • Frederick Masoudi, MD, MSPH, University of Colorado Anschutz Medical Campus
  • Joe Ross, MD, MHS, Yale University
  • Art Sedrakyan, MD, PhD, Weill Cornell Medicine
  • James Tcheng, MD, Duke University Health System
  • Charles Viviano, MD, PhD, U.S. Food and Drug Administration (FDA)/ Center for Devices and Radiological Health CDRH/ODE/DRGUD

NESTcc was established in 2016 to support the sustainable generation and use of timely, reliable, and cost-effective real-world evidence throughout the medical device lifecycle, using real-world data that meets robust methodological standards and is generated in the course of clinical care and everyday life by patients, providers, or payers, and for the purpose of enhancing regulatory and clinical decision-making.

DCRI-led think tank addresses opportunities and challenges of digital technology in health care

June 4, 2018 – The DCRI brought together national leaders to address the promise and challenges facing digital health technologies in the transformation of health care.

A paper published today in the Journal of the American College of Cardiology summarized the proceedings of a multi-faceted think tank meeting organized by the DCRI in December 2016 in Washington DC. A cross-section of stakeholders including academics, industry and regulatory representatives convened at the meeting to address both the potential of and challenges facing digital health technologies in the transformation of health care in the United States.

“The primary aims of this meeting were to really understand the landscape of digital technology and how it’s currently being used in health care,” said former DCRI Fellow Abhinav Sharma, MD, first author of the study. “We wanted to dive in deep to identify issues and barriers with regards to the development of these technologies and their adoption, and to identify solutions using perspectives from providers, industry, regulatory agencies, payers and professional societies, to use this innovation to drive better delivery of health care.”

According to Sharma, modern health care is literally shifting from clinics and hospitals to the palm of a patient’s hand. There are many examples of how a patient can now enter information on their cellphone and through a dynamic decision algorithm, find out exactly how they should be treated and medicated from the comfort of a familiar home setting. Digital technology is being used not only as a diagnostic tool, but also as a decision support tool, to recruit patients for clinical trials and for informed consent.

“Digital technology is completely revolutionizing the way that we think about health care,” said Sharma, “and it is becoming so much more necessary as our health care costs explode on an unprecedented scale, increasingly lessening our ability to take in, treat and manage complicated diseases in a traditional brick and mortar hospital setting.”

But with all these potential upsides, there are also countless challenges that need to be addressed. According to Sharma, one of the biggest concerns is health data privacy. With a lot of money being pushed into cellphone apps and other digital platforms, it becomes even more critical to ensure there is some degree of regulation on how health data is utilized and the way it is stored and the privacy that comes along with it, so issues like the ones that have happened with popular social media platforms recently can be avoided.

“Interoperability of data is another major challenge, where health record platforms in multiple institutions have no way of connecting with one another,” said Sharma. “There is also an inherent ‘productivity paradox’, where there is a visible decrease in productivity because people don’t really know how to use all this new technology such as gadgets and devices, and the data generated from them to improve the delivery of health care without losing valuable time, energy and resources,” he said.

“Ultimately, we need to make sure our enthusiasm for technology doesn’t outpace our need to validate them,” said Sharma. “Both users and developers need to weigh all new inventions and devices against their preexisting counterparts and see whether or not they improve upon or increase the quality, cost and use of care in comparison.”

The paper strongly advocates the rapid development and implementation of innovation networks on a local, regional and national scale, combining brainpower from academics, entrepreneurs, agencies, associations/societies and regulatory bodies such as the Food and Drug Administration, to review novel technology as soon as it hits the market.

“Digital technology like cellphones have completely revolutionized and changed the way we think about health care,” said Sharma. “When you think of the computational power just in the phone alone, it completely outsmarts most of the computers that we have had in the past.”

According to Sharma, leveraging this phone-based and app-based technology is where a lot of the future is going to be headed. But as digital innovations become more readily available, establishing a proper framework for their appropriate use and rigorous standards of regulation become even more essential.

In addition to Sharma, other authors included Robert A. Harrington, Mark B. McClellan, Mintu P. Turakhia, Zubin J. Eapen, Steven Steinhubl, James R. Mault, Maulik D. Majmudar, Lothar Roessig, Karen J. Chandross, Cheryl A. Boyce, Eric M. Green, Bakul Patel, Andrew Hamer, Jeffrey Olgin, John S. Rumsfeld, Matthew T. Roe and Eric D. Peterson.