September 6, 2019: Transforming Medical Evidence Generation with Technology-Enabled Trials (Matthew T. Roe, MD MHS)

Speaker

Matthew T. Roe, MD, MHS
Senior Investigator, Professor of Medicine
Duke Clinical Research Institute

Topic

Transforming Medical Evidence Generation with Technology-Enabled Trials

Keywords

Mobile clinical trials; Real-world evidence; Real-world data; Study design; Regulatory oversight; Digital health; Mobile health applications; Biosensors; Electronic health records

Key Points

  • Digital health applications and electronic health records provide tremendous opportunities for improving trial efficiencies, broadening patient participation, and reducing cost.
  • Novel approaches that can help reduce data collection burden for study sites include importing EHR data directly into the trial database, collecting patient-reported outcomes through web-based portals, and incorporating digital health data from wearables and biosensors.
  • To realize the potential of new technology, cross-sectional partnerships are needed among research participants, researchers, biopharma device industries, professional medical associations, insurers, FDA, clinicians, health IT, contract research organizations, and health systems.

Discussion Themes

How many potential patients might we lose if having a smart phone is an inclusion criterion for a clinical study?

How can we ensure that the clinical trial infrastructure is inclusive of minority populations, especially those in rural settings?

What is the role of physicians in reaching a large number of participants who are not near an academic research center?

Ultimately, in clinical trials, the data are what matter and what decisions are based on. We need to understand data quality and standards for the data to be accepted.

Read more about digital health at FDA’s Digital Health website.

Tags

#pctGR, @Collaboratory1, @MTRHeart

August 16, 2019: Introducing the Digital Medicine Society (Andy Coravos, MBA, Jen Goldsack, MS, MBA)

Speakers

Andy Coravos
CEO, Elektra Labs
Fellow, Harvard-MIT Center for Regulatory Science
Co-founder, Digital Medicine Society (DiMe)

Jen Goldsack, MS, MBA
Interim Executive Director, DiMe
Portfolio, Strategy & Ops, HealthMode

Topic

Introducing the Digital Medicine Society

Keywords

Digital medicine; Mobile health; Digital technologies; Wearable health devices; Connected devices; Cybersecurity

Key Points

  • Digital medicine is a rapidly evolving field that is by nature multidisciplinary and introduces new considerations for the healthcare community.
  • The Digital Medicine Society (DiMe) sits at the intersection of two communities: healthcare and technology. The Society is helping to move the field of digital medicine forward by developing a common language for diverse stakeholders from engineers and ethicists to payers and providers.
  • The U.S. healthcare system has strong protections for patients’ biospecimens like blood or genomic data, but what about digital specimens?

Discussion Themes

Are digital medical technologies worthy of the trust we place in them?

Should there be a Hippocratic Oath for manufacturers, organizations, and individuals delivering care through connected medical devices?

Read more about the emerging field of digital medicine and learn more about the Digital Medicine Society (DiMe), the professional home for those who practice and develop products in the digital era of medicine.

Tags

#DigitalMedicine, #pctGR, @Collaboratory1, @_DiMeSociety

August 2, 2019: AI and the Future of Psychiatry (Murali Doraiswamy, MBBS)

Speaker

Murali Doraiswamy, MBBS
Professor of Psychiatry and Behavioral Sciences
Duke School of Medicine

Topic

AI and the Future of Psychiatry

Keywords

Artificial intelligence; Machine learning; Psychiatry; Ethical adoption of technologies; Mental health; Wearables; Mobile health

Key Points

  • There is growing evidence from randomized controlled trials of the efficacy of using digital tools in mental health diagnosis and treatment.
  • Could artificial intelligence (AI) and machine learning technologies be used to:
    • Reduce the stigma associated with mental health treatment?
    • Predict the risk for future suicide?
    • Detect Alzheimer’s years before diagnosis?
  • Categories of AI applications include low-risk apps that measure but do not diagnose, and apps used in diagnosis or treatment that must meet the same high standards of evidence as medications.
  • Clinicians still struggle with how to integrate patient data from wearable devices. AI technology might help if it could be used to synthesize the data into a risk profile for an individual.

Discussion Themes

What are the roles of stress, exercise, and sleep in mental health, and can autonomic data from wearables help explain the variance in mental health symptoms?

To develop evidence thresholds for AI, we need larger scale public-private partnerships as well as pragmatic trials addressing key clinical questions.

Read more from Dr. Doraiswamy in How to Use Technology Ethically to Increase Access to Mental Healthcare.
Tags

#AI, #pctGR, @Collaboratory1

July 26, 2019: Digital in Trials: Improving Participation and Enabling Novel Endpoints (Craig H. Lipset)

Speaker

Craig H. Lipset
Former Head of Clinical Innovation, Pfizer

Topic

Digital in Trials: Improving Participation and Enabling Novel Endpoints

Keywords

Digital tools; Clinical trials; Participant experience; Patient engagement; Clinical Trials Transformation Initiative

Key Points

  • To improve trial participation, start by understanding the user/consumer; ie, the trial participant and his or her trial experience.
  • Digital improvements in clinical trials can involve these incremental steps:
    • Study planning that is data-driven, crowdsourced, and informed by artificial intelligence
    • Patient engagement that implements electronic consent, flexibility in location, digital concierge support, and data ownership
    • Study conduct that integrates remote monitoring, digital biomarkers, and electronically sourced data
    • Analysis and reporting that is automated and includes dissemination to trial participants

Discussion Themes

Will digital tools in medicine development enable improvement, disruption, or displacement?

Digital tools in development focus on breaking down barriers to participation, using digital to improve existing measurement or enable new endpoints, and automating processes and tasks while improving quality.

Tags

#pctGR, @Collaboratory1

July 2, 2019: New Living Textbook Section on Inpatient Endpoints in Pragmatic Clinical Trials

A new section in the Living Textbook describes the considerations for using “real-world” data for inpatient-based event ascertainment. There are many sources for acquiring this information, and they have different time lags in their availability and varying degrees of error and bias. In order to use inpatient endpoints in pragmatic clinical trials, these factors must be understood during the design, conduct, and analysis phases of an embedded pragmatic clinical trial.

“The pragmatic trial community needs to collectively determine which endpoints are relevant for pragmatic trials, how they can be measured and validated, and how the accuracy of these measurement methods may impact hypothesis testing sample size estimates.” —Eisenstein et al 2019

Topics in the chapter include:

  • Pragmatic trial inpatient endpoints
  • Inpatient event data sources
  • Patient-reported data
  • Secondary data sources: EHR
  • Secondary data sources: claims
  • Case studies: ICD-Pieces, TRANSFORM-HF, ADAPTABLE, and TRANSLATE ACS
  • Data source accuracy

 

May 10, 2019: Treating Data as an Asset: Data Entrepreneurship in the Service of Patients (Eric Perakslis, PhD)

Speaker

Eric D. Perakslis MS, PhD
Rubenstein Fellow, Duke University
Lecturer, Department of Biomedical Informatics
Harvard Medical School

Topic

Treating Data as an Asset: Data Entrepreneurship in the Service of Patients

Keywords

Digital health; Health data; General Data Protection Regulation (GDPR); Data sharing

Key Points

  • The only 100% common element of digital transformation across all industries is data.
  • With data and digital transformation, patients are changing: They are active, connected, informed, and savvy.
  • Security, compliance, and privacy are different things.

Discussion Themes

Is there any hope of data sharing policies helping to bridge the micro and macro silos of healthcare data?

As data starts to flows through institutions, it ends up in multiple places. Part of sharing data is protecting a single source of truth.

If something is relevant to the bedside, it’s worth doing.

Read Dr. Perakslis’s commentary in The Lancet (May 2019).

Tags

#healthdata, #pctGR, @Collaboratory1

July 30, 2018: Registration Open for 3rd Seattle Symposium on Health Care Data Analytics

Registration is open for the 3rd Seattle Symposium on Health Care Data Analytics. The symposium will bring together biostatisticians, health informaticists, epidemiologists, and other data scientists to discuss health research and methods that involve large health care databases.

Experts involved in national research initiatives that use large health care databases will discuss methodological challenges encountered in this setting and share ideas for addressing them. Speakers will share their research on:

  • statistical approaches to learning from electronic health care data;
  • methods for precision medicine; and
  • health policy.

Space is limited, and registration is required.

The event is sponsored by the Biostatistics Unit at Kaiser Permanente Washington Health Research Institute and the Department of Biostatistics at the University of Washington.

Mobile Health (mHealth) Research Platform to Launch


In recent health information technology news, the University of California, San Francisco (UCSF), has received a 5-year National Institutes of Health award to support its launch of a cardiovascular mHealth platform. The research platform, to be named Health ePeople, will build on the successes of UCSF’s Health eHeart Study, which began in 2013. That study, with more than 30,000 participants worldwide, uses the power of mobile technologies to collect cardiovascular data and patient-reported outcomes (PROs) from study participants.

The Health ePeople platform will advance mHealth by providing researchers with easy access to a large cohort of volunteers, along with a quick, affordable means for collecting their health data through mobile and wireless technologies. Though the platform will not be ready to enroll new participants for several months, people who want to participate in the cohort can sign up through the Health eHeart Study website.

For information and short videos on mHealth technologies, visit the Living Textbook’s chapter on mHealth and PROs.


Latest Truven Health Analytics–NPR Health Poll on Medical Data Privacy


How concerned are people about the privacy of their medical information? Not very—according to the November 2014 Truven Health Analytics–NPR Health Poll (opens as PDF). The poll asked how respondents feel about sharing their electronic health information and other data with researchers, employers, health plans, and their doctors. The majority expressed a willingness to share their anonymized health information with researchers; less than a quarter expressed willingness to share non-healthcare data with their healthcare providers.

Each month, the Truven Health Analytics–NPR Health Poll surveys approximately 3,000 Americans to gauge attitudes and opinions on a wide range of healthcare issues. Poll results are reported by NPR on the health blog Shots. Among the results of this survey:

  • 74% of respondents indicated that their physician uses an electronic medical record system.
  • 68% of respondents would share their health information anonymously with researchers.
  • 44% of respondents have looked through their health information kept by their physician.

The survey analyses were stratified by age, education, generation, and income. Poll questions were posed by cell phone, land line, and online during the first half of August 2014. The margin of error was plus or minus 1.8 percentage points. An executive summary of the survey, including questions and survey data, is here.