In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Michelle Mello discusses a study she and Dr. Steven Goodman recently conducted to determine how clinical trial participants think about having their participant-level data widely shared. In her discussion with Dr. Lesley Curtis, Dr. Mello discusses study results, what she found most surprising, and how the study revealed takeaways for researchers and clinical trial sponsors.
Michelle M. Mello, JD, PhD
Professor of Law, Stanford Law School
Professor of Health Research and Policy, Stanford University School of Medicine
Steven Goodman, MD, MHS, PhD
Associate Dean, Clinical and Translational Research
Professor of Medicine and Health Research and Policy
Stanford University School of Medicine
Vice-chair, PCORI Methodology Committee
Clinical Trial Data Sharing: Perspectives from Participants and PCORI
Clinical research; Data sharing; Data metrics; Patient-Centered Outcomes Research Institute; PCORI; Patient participation; Patient perspective
The presenters conducted a study that explored patients’ perspectives on being included in clinical trials. The study aimed to understand how patients feel about being part of trials and potential risks associated with the use of their clinical data.
The majority of participants indicated that potential health benefits for their children or themselves is their primary reason for their clinical trial participation.
The majority of participants view the benefits of data sharing as greatly outweighing the potential risks.
The distinction between anonymous and de-identified data is an important one. Many people do not know what de-identified means and lack understanding that it is different from data being anonymous.
Data linkage is key in achieving data longevity. It would be interesting to extend some of the findings to better understand how the average American understands how their data could potentially be reused.
While the results of this study are not generalizable to those not actively participating in clinical trials, it is important to note that historical data have shown that most people prefer being asked to use their data for research purposes.
In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Aaron McKethan discusses the idea of rethinking research with state-level data. Dr. McKethan serves as a faculty member in the Department of Population Health Sciences at Duke University and is the Chief Data and Analytics Officer for the NC Department of Health and Human Services. With his unique perspective, Dr. McKethan provides insight into how universities and local governments can best work together to improve data quality, reduce inefficiencies, and improve collaborations.
Aaron McKethan, PhD
Assistant Professor of Population Health Sciences, Duke School of Medicine
Senior Policy Fellow, Duke-Margolis Center for Health Policy
Chief Data Officer, NC DHHS
Policy & Priorities: Rethinking University Research with State Data
State data; Policy implications; Research; Analytic priorities; Front-end technology
In order to effectively incorporate state data in university research, policy implications must be considered at the beginning of the planning process.
There is a need for analytic priorities when determining how to rethink university research with state data.
What is known? What is not known? What are the highest-priority questions? These are the types of questions that must be asked when determining analytic priorities for the inclusion of state data in university research.
Using state data to help support university research provides better front-end technology, collaboration with community-based organizations, and more.
Being explicit about the type of analytics and the research questions we are trying to answer, will improve the process of better understanding how policy and priorities of the state can be used to impact university-level research.
To impact policy, we must be open to arrangements between the state and universities that will potentially generate research results may be hard to publish but could be widely impactful.
The notion of incorporating state data into university-level research is, in a way, related to the work of NIH Collaboratory and PCORnet. All entities are working towards making research more accessible and practical.
NIA recently released an RFA for a new HCS Research Collaboratory focused on AD/ADRD, RFA-AG-19-009.
“The purpose of this FOA is to solicit applications for the AD/ADRD Health Care Systems Research Collaboratory (“Collaboratory,” henceforth) to improve care for persons with dementia (PWD) and their caregivers through health systems. Health and long-term systems for this FOA are defined broadly and include organizations providing care across settings to include primary and specialty outpatient care, acute inpatient care, skilled nursing and other rehabilitation facilities, residential long-term care, and home and community-based services. Organizations may be traditional health care systems (e.g., health maintenance organizations, or HMOs), health insurance companies, managed care plans, home health care providers, memory clinics, nursing homes, assisted living facilities, outpatient clinics, federally-designated health centers, hospitals, and other providers of acute and long-term care. The Collaboratory will: 1) serve as a national resource to promote development of pragmatic trials and demonstration projects to improve care and health outcomes for PWD and their caregivers; 2) support pilot pragmatic trials within the Collaboratory; 3) develop and disseminate technical and policy guidelines and best practices for effectively conducting AD/ADRD research studies in partnership with health care systems; 4) work collaboratively with researchers to provide technical support for scaling up pilot studies; and 5) disseminate best practices for engaging stakeholders, conducting ethical research in the special circumstances of dementia care, and involving long-term and acute-care providers.”
All applications are due September 6, 2018, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.
No late applications will be accepted for this Funding Opportunity Announcement.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
In a new episode of the NIH Collaboratory Grand Rounds podcast, Dr. Amy Abernethy discusses research at scale, with examples from Flatiron Health. In her discussion with moderator Adrian Hernandez, Dr. Abernethy focuses on the goals of Flatiron Health, approaches for building data-sets and underlying infrastructure, what’s next on the horizon for Flatiron Health, and more.
Tracy Y. Wang, MD, MHS, MSc
Director, DCRI Health Service Research
Fellowship Associate Program Director
Associate Professor of Medicine, Cardiology
Duke University Medical Center
Pragmatic Trial Design to Study Health Policy Interventions: Lessons Learned from ARTEMIS
Clinical research; Pragmatic clinical trial; Pragmatic trial design; Health policy; ARTEMIS; Health policy; Health system; Cost-sharing models
The ARTEMIS trial aims to improve patient outcomes by simulating health system and payer consideration of novel cost-sharing models.
Health policy and implementation studies require pragmatic trial design.
The ARTEMIS trial consists of 301 sites across the United States, with 23% classified as teaching hospitals.
Design and execution of the ARTEMIS trial prompted many questions, such as “Can we innovate the design of pragmatic health policy trials?”
As with most pragmatic clinical trials, the ARTEMIS trial is aimed at decision makers. However, in ARTEMIS, the “decision makers” are the healthcare systems, as well as the payers which is unusual as compared to most pragmatic clinical trials.
Variability in payment coverage contributed to the design of the ARTEMIS trial.
While the patient population in the ARTEMIS trial is analogous, the randomization of hospitals and the way in which the work of the hospitals is conducted is highly variable. Linking and data collection helped contribute to ARTEMIS findings.
Amy P. Abernethy MD, MPH
Chief Medical Officer, Chief Scientific Officer, SVP Oncology
Research at Scale – Exploring What is Possible with High-Quality Real-World Data. Examples from Flatiron Health.
Clinical research; Clinical trials; Health data; Cancer research; Flatiron health; Real-world evidence; High-quality data; Real-world data
Flatiron Health is evaluating the emerging role of data and technology to reimagine the clinical trials process from design through execution. Their technology is standardizing electronic health record data to a common data model, enabling millions of electronic health records in a single common dataset.
The 21st Century Cures Act presents an opportunity to use regulatory-grade real-world evidence. Characteristics of real-world data and real-world evidence have the potential to improve the clinical depth and completeness of health data as well as scalability and generalizability.
The addition of other linked datasets will provide a broader set of data and contribute to the expansion of use for other systems. The more datasets, the more “triangular” the sets will become. The more that high-quality real-world datasets are used in concert, the better.
Linkage to data claims is an integral piece of the high-quality real-world data puzzle. With large portions of oncological data, necessary records can be abstracted, providing simplicity in linking.
The objective of the PROVEN trial is to conduct a pragmatic cluster-randomized clinical trial of an advance care planning video shown to nursing home patients with advanced conditions in 2 nursing home healthcare systems.
Distribution of the nursing home sites for the PROVEN trial involves intervention and control centers and is far-reaching across the United States.
A primary challenge of the PROVEN trial is defining compliance and triaging long-stay patients.
Implementing interventions into nursing home healthcare systems in pragmatic clinical trials requires a mandate from senior management and endorsement in standard operating procedures.
The PROVEN trial is a first of its kind. Much has been discovered and additional lessons will be learned over time.
Reducing hospitalization served as an incentive for many of the PROVEN partnering organizations. However, the same incentive is used elsewhere in the market, so the potential of including some sort of financial incentive is something that has been discussed.
The advance care planning videos are intended to serve as a catalyst for better care. Patient and caretaker engagement is the ultimate goal. The videos help provide a more engaged and collaborative environment for patients and can better inform the medical team on why decisions are made by patients and their families.
Currently, there is a lack of the sites in the Midwest region due to the nature of the market.
S. Claiborne “Clay” Johnston, MD, PhD, MPH
Dean and Vice President for Medical Affairs
Dell Medical School, The University of Texas at Austin
How Would You Build an Academic Medical System to Bridge Research and Care if You Could Start from Scratch?
Real-world evidence; Clinical research; Clinical decisions; Healthcare; Medical systems; Patient experience; Physicians; Clinical data
About 20% of major clinical decisions are based on real-world evidence. This low percentage perpetuates an inconsistency between the research that is conducted and the care that is provided to patients.
The recently established Dell Medical School, at The University of Texas at Austin, aims to start from scratch by building a bridge between research and care. This effort involves a cycle of outcomes that includes payment for value, design, clinical expertise, team care, and technology.
To change the relationship between research and care for individuals, we must ask tough questions like, “Can we reduce physician distraction and improve the patient experience?”
Consent is often an underutilized area of routine care. Consent, through the work being done at Dell Medical School, is provided on a case-by-case basis, in addition to “blanket consent.”
New schools, like Dell Medical School, have the advantage to take bigger leaps in exploring the connection between research and care. Demonstrating what works and what doesn’t helps to create a business case for other schools and research entities.
Setting up a medical school in a nontraditional way has a large impact on medical students and residents; for example, the novel curriculum and increased interest in medical school applicants who exemplify leadership and creativity skills.
Key success factor: Prime everyone to truly care about improving health.
For more information on Dell Medical School, visit dellmed.utexas.edu and follow @DellMedSchool.