Chase is senior director for clinical trial operations at Mass General’s Neurological Clinical Research Institute. Goldhahn is medical director of the Institute for Translational Medicine at ETH Zurich.
Eric Perakslis, PhD
Chief Science & Digital Officer
Duke Clinical Research Institute
Professor
Department of Population Health Sciences
Chief Research Technology Strategist
Duke University School of Medicine
Topic
Cyberthreat, Cybersecurity and Cyber Compliance in Clinical Research and Healthcare: One Size Fits None
Over 40 million medical records are compromised each year.
Electronic Health Information is targeted due to its high value with respect to improper medical payments. Medicare estimates over $25 billion in improper payments each year.
The focus for cybersecurity should be on the most vulnerable groups. Women, BIPOC, and elderly populations experience cyberattack and identity theft more often than other populations.
Security objectives should focus on confidentiality, integrity, and availability.
The Cyber Risk Equation: Risk = Threat*Vulnerability*Impact*Likelihood
When starting a study, design with cybersecurity in mind, minimize attack surface, know your weakest link, add InfoSec expertise to the design team, and lean-in to innovation.
Discussion Themes
Researchers should take some responsibility for learning how to secure patient information. Training programs to make researchers more aware of cybersecurity concerns would increase researcher comfort in working with electronic health data.
A research network consisting on multiple sites may have differing needs and capacity to secure data. Treating each research site individually could allow greater representation in research, but those sites may be more vulnerable to cyberattack.
Dr. Agarwal is an assistant professor of emergency medicine at Penn and the clinical innovation manager at the Penn Medicine Center for Health Care Innovation.
The Grand Rounds session will be held on Friday, November 19, at 1:00 pm eastern. Join the online meeting.
In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Megan Ranney and Dr. Adrian Hernandez continue the discussion about using digital technologies in clinical trials and best practices for online participant recruitment. The full May 7 Grand Rounds webinar with Dr. Ranney is also available.
Megan L. Ranney, MD, MPH, FACEP Director, Brown-Lifespan Center for Digital Health Warren Alpert Endowed Associate Professor of Emergency Medicine, Brown University Associate Dean of Strategy and Innovation, School of Public Health, Brown University Chief Research Officer, AFFIRM Co-founder, GetUsPPE
Topic
Online Recruitment in the Era of COVID-19: Pitfalls and Progress
Keywords
COVID-19; Online trial recruitment; Clinical trials; Emergency medicine; Digital health technologies; Remote interventions; Electronic informed consent
Key Points
The Center for Digital Health at Brown University is a research and education hub that explores innovative solutions to urgent health challenges. The Center has supported studies involving the use of digital health technologies for recruiting participants and delivering behavioral health interventions.
Due to disruptions caused by the COVID-19 pandemic, many research studies pivoted from in-person contact toward the use of digital technologies such as smartphone apps and remote telehealth.
To advance clinical trials in a post-pandemic world, we will need to establish best practices for digital health technologies—and recognize when online recruitment is appropriate and when it is not. Hybrid recruitment models offer a solution.
Discussion Themes
It remains clear that the relationship between study staff and participants is essential to forming positive alliances and determines the likelihood of follow up.
For social media advertising, it’s possible that an IRB could approve a group of images, headlines, and content that study teams can combine in different ways to optimize the advertising over the course of a study.
The Pew Research Center provides recent data on which social media platforms are used most by Americans. Read more about digital health science at the Center for Digital Health.
A recent Grand Rounds webinar presented by C. Michael Gibson, MS, MD, described how open access, patient empowerment, social media, and digital health are transforming clinical trials. Dr. Gibson is a professor of medicine at Harvard Medical School and president and CEO of Baim and PERFUSE Research Institutes.
Among the key points:
The COVID-19 pandemic has been a call to arms to physicians to combat not only the virus but the misinformation.
As the internet is replacing the printing press, “copyleft” is replacing copyright in this new open-access era. It is a participatory community with bidirectional flow of information through social media.
Health data does not equal health care. Patients are looking to physicians to curate health information.
In this new world of clinical research, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.
Patient-empowered trials have the potential to provide more generalizable study results and to lead to patient-specific predictions through use of artificial intelligence.
C. Michael Gibson, MS, MD Professor of Medicine Harvard Medical School President and CEO Baim and PERFUSE Research Institutes
Topic
The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research
Keywords
Clinical research; Open access; Social media; Artificial intelligence; Heartline study; WikiDoc; WikiPatient
Key Points
As the internet is replacing the printing press, “copyleft” is replacing copyright in the open-access era. It is a participatory community with bidirectional flow of information through social media.
Health data does not equal health care. Patients are looking to physicians to curate health information from huge volumes of data.
Social media and open access during the COVID-19 pandemic has meant that physicians are citizen journalists, innovators, activists, and educators.
In this new world, patients are enrolling in virtual trials via a phone app and will be followed up online through claims data and patient-reported outcomes.
Discussion Themes
The COVID-19 pandemic has been a call to arms to clinicians to combat not only the virus but the misinformation. As educators we must set the path and not allow uninformed people to take control.
Enabling patient-empowered trials has the potential for more generalizable study results and can lead to patient-specific predictions through use of artificial intelligence.
How do we validate the quality of open-access data and reports that are not peer-reviewed?
How can we diminish the hazards of skewed research outcomes arising from trial participant conversations on social media?
In case you missed the May 1 keynote address by Robert M. Califf, MD, MACC, you can now listen to the recorded webinar and Q&A. Dr. Califf, head of strategy and policy for Verily Life Sciences and Google Health, kicked off the Collaboratory’s Grand Rounds workshop series, Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials.
His presentation outlined several opportunities to drive change and rebuild clinical research in the aftermath of COVID-19, including:
Evaluate what has and has not worked in the changes that have been made in response to the crisis
Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
Do everything possible to fix the “purposefulness issue”:
Create methods for deciding the most important questions
Reward behavior that gets important questions answered quickly
Develop inclusive networks driven by people with the health problems of interest; increase incentives for clinicians and investigators that lead to reliable and faster evidence generation (balance financial focus with purpose); and automate mapping of EHR data beyond individual systems
“The effective use of digital information such as electronic health records, telehealth, applications, and patient-reported outcomes should free up effort to fix the human components that are holding us back.” – Dr. Robert Califf
Recording June 30, Available July 7, 2020: Podcast: Summary Expert Panel Discussion (Patrick J. Heagerty, PhD; Keith Marsolo, PhD; Wendy Weber, ND, PhD, MPH; Moderator: Lesley H. Curtis, PhD)
Robert Califf, MD, MACC Head of Strategy and Policy Verily Life Sciences and Google Health
Topic
Advances at the Intersection of Digital Health, Electronic Health Records, and Pragmatic Clinical Trials: Keynote-Can the COVID-19 Crisis Lead to Reformation of the Evidence Generation Ecosystem?
Keywords
Electronic health records; Digital health; Mobile health; Coronavirus; COVID-19; Ecosystem; Clinical trials; Evidence generation
Key Points
The HERO Registry and RECOVERY Trial are good examples of a rapid clinical research response to the urgent COVID-19 health crisis.
Among the essential steps to move the evidence generation system in the right direction:
Evaluate what has and has not worked in the changes made in response to the crisis
Allocate a significant part of recovery funding to transition issues in evidence generation, especially at the interface of medicine and public health
Increase purposefulness by creating methods for deciding the most important questions and rewarding behavior that gets those questions answered quickly
Discussion Themes
The COVID-19 pandemic has shone a spotlight on disparities in our current healthcare delivery system. How can we avoid leaving the most vulnerable of society behind?
Telemedicine can be a framework for the integration of research and clinical care. But the digital element must be integrated with the human element. The routine and effective use of digital information should free up effort to fix the human components that are holding us back.
We’ve been trying to modernize clinical trial design for decades (factorial/sequential/adaptive designs for example). While some positive movement in the past month has been made, the research enterprise remains largely conservative when it comes to design modernization. How do we make more rapid progress?
NIH Collaboratory Grand Rounds will launch a special workshop series next month to explore challenges and opportunities in using electronic health records (EHRs) in pragmatic clinical trials. The series will highlight advances in digital health, new approaches and evolving standards for EHRs, and implications for researchers conducting pragmatic trials.
The webinar series, Advances at the Intersection of Digital Health, Electronic Health Records and Pragmatic Clinical Trials, will kick off on May 1 with a keynote presentation by Dr. Robert Califf, head of strategy and policy for Verily Life Sciences and Google Health.
The new Grand Rounds series will include moderated panel discussions that focus on the use of digital technologies in pragmatic clinical trials, case examples from the NIH Collaboratory Demonstration Projects, and recent initiatives from the Office of the National Coordinator for Health Information Technology to reshape standards and drive the evolution of EHRs in healthcare and research. A podcast discussion with a panel of experts will wrap up the series in July.
In this Friday’s PCT Grand Rounds, Marianne Chase of Massachusetts General Hospital and Dr. Jörg Goldhahn of ETH Zurich will present “CTTI’s Digital Health Trials Hub: Multi-Stakeholder Resources to Conduct Effective Digital Health Trials.” The Grand Rounds session will be held on Friday, September 30, 2022, at 1:00 pm eastern.
In the latest episode of the 