data sharing

November 3, 2020: Disseminating Trial Results: We Can Have Faster and Better

Posted on by Karen Staman

Healthcare cover imageNIH Collaboratory investigators Drs. Greg Simon, Rachel Richesson, and Adrian Hernandez published an opinion piece in Healthcare arguing that clinical trials investigators should align their dissemination processes with industry-sponsored trials to favor speed, and that years-long delays in dissemination reduce the relevance of clinical research.

“Delays reduce the ability for researchers to apply trial findings to new research questions, impede clinicians from having the most up-to-date information, and perhaps most importantly, are a disservice to patients who could benefit from the information.”

The authors use experiences with pragmatic trials supported by the NIH Collaboratory to explore faster dissemination of results, and suggest the following solutions:

  • Real-time access to outcome data
  • Continuous data curation and cleaning
  • Immediate data analysis
  • Rapid reporting of trial results

Much change is needed to reach these goals. The authors suggest that by modeling processes after industry-sponsored trials, researchers may be able to improve the speed and quality of results reporting.

“Cultural incentives are aligned in industry sponsored trials to favor speed: readiness for generalizing topline results is considered valuable to shareholders, and the culture encourages a system where data are liquid, available, and continuously cleaned and curated, such that topline results can be reported within a timespan of two weeks rather than two years.”

As part of the NIH Collaboratory’s commitment to dissemination and sharing, all NIH Collaboratory Trials are expected to share data and resources, and topline results are reported in our weekly Grand Rounds Webinars.

 

September 11, 2020: Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (Gordon Bernard, MD; Sonia Thomas, DrPH)

Posted on by Gina Uhlenbrauck

Speakers

Gordon R. Bernard, MD
CONNECTS ACC Science Unit P
Professor of Medicine
Executive Vice President for Research
Senior Associate Dean for Clinical Science
Vanderbilt University Medical Center

Sonia Thomas, DrPH
CONNECTS ACC Principal Investigator
Senior Research Statistician
RTI International

Topic

Launching CONNECTS: Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies

Keywords

COVID-19; CONNECTS; NHLBI; Collaborative research; Data sharing; Adaptive trials; Data standardization; ACTIV; Therapeutic agent prioritization

Key Points

  • The Collaborating Network of Networks for Evaluating COVID-19 and Therapeutic Strategies (CONNECTS) is a research partnership coordinated by the Research Triangle Institute, Vanderbilt University Medical Center, and the National Heart, Lung, and Blood Institute (NHLBI) of the NIH.
  • CONNECTS aims to build on existing clinical research networks to better understand the risk of severe illness from COVID-19 and to identify therapies that will slow or halt the disease progression and speed recovery. Studies will enroll participants with health conditions that are known to increase their risk for severe complications from COVID-19.
  • The immediate goal is to design and implement master protocol-driven adaptive clinical trials, including outpatient, inpatient, and recovering master protocols.
  • CONNECTS is part of a larger ecosystem in the Department of Health and Human Services that includes the FDA, CDC, BARDA, Operation Warp Speed, and NIH. More than 34 trial networks and 1,000 sites are participating in CONNECTS.

Discussion Themes

Are the CONNECTS resources, such as the common data elements manual, draft protocols, and case report forms, publicly available?

In your effort to reach underrepresented communities, have you considered collaborating with Historically Black Colleges and Universities (HBCUs), particularly those that conduct health research?

While COVID-19 is providing you with plenty to focus on, do you see the potential for sustainability of CONNECTS beyond this pandemic?

Read more about CONNECTS.

Tags

#pctGR, @Collaboratory1

August 18, 2020: Grand Rounds Podcast With C. Michael Gibson on the Democratization of Medicine Is Available

Posted on by Gina Uhlenbrauck

In the latest episode of the NIH Collaboratory Grand Rounds podcast, Dr. Adrian Hernandez and Dr. C. Michael Gibson continue the discussion of how medicine and medical research are being transformed through patient empowerment and information sharing. Their conversation provides a deeper look into the power of social media and the role of physicians as citizen journalists, innovators, activists, and educators. The full August 7 Grand Rounds webinar with Dr. Gibson is also available.

August 11, 2020: Grand Rounds Webinar Discusses the Democratization of Medical Research

Posted on by Gina Uhlenbrauck

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.

Watch the complete webinar and download the slides.

Read more in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (Gibson, JAMA Cardiology, 2017) and learn about the Heartline Study as an example of a “giga trial.”

August 7, 2020: The Democratization of Medicine: Open Access, Social Media, AI, Apps, and Empowering the Patient as the Future of Clinical Research (C. Michael Gibson, MS, MD)

Posted on by Gina Uhlenbrauck

Speaker

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?

Read more from C. Michael Gibson in The Democratization of Medical Research and Education Through Social Media: The Potential and the Peril (JAMA Cardiology 2017).

Tags

#pctGR, @Collaboratory1

July 8, 2020: NIH Collaboratory COVID-19 Grand Rounds Series Continues With the National COVID Cohort Collaborative Data Enclave

Posted on by Damon Seils

The NIH Collaboratory Coordinating Center is using its popular Grand Rounds platform to share late-breaking research and promote resources in support of clinical researchers affected by the COVID-19 public health emergency.

In this week’s COVID-19 Grand Rounds session, Dr. Ken Gersing of the National Center for Advancing Translational Sciences and Dr. Robert Star of the National Institute of Diabetes and Digestive and Kidney Diseases will present “COVID Open Science Collaborative Analytics Platform: National COVID Cohort Collaborative (N3C).” The Grand Rounds session will be held on Friday, July 10, at 1:00 pm eastern. Join the online meeting.

Drs. Gersing and Star will discuss the recent launch by the NIH of a centralized data repository and analytics platform, the N3C Data Enclave, to store and study large quantities of medical record data from people diagnosed with COVID-19 in the United States.

Previous COVID-19 Grand Rounds:

For more news and resources related to the COVID-19 public health emergency, see the COVID-19 Resources page.

June 5, 2020: PCORnet COVID-19 Common Data Model Design and Results (Thomas Carton, PhD, MS; Keith Marsolo, PhD; Jason Perry Block, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Thomas W. Carton, PhD, MS
Chief Data Officer
Louisiana Public Health Institute

Keith Marsolo, PhD
Associate Professor
Department of Population Health Sciences
Duke Clinical Research Institute
Duke University School of Medicine

Jason Perry Block, MD, MPH
Associate Professor of Population Medicine
Department of Population Medicine Harvard
Pilgrim Health Care Institute
Harvard Medical School

Topic

PCORnet COVID-19 Common Data Model Design and Results

Keywords

COVID-19; PCORnet; Common Data Model; CDM; Data query; Health disparities; Distributed data network

Key Points

  • For data to be useful in research, they have to be standardized across systems. The PCORnet Common Data Model standardizes data into a single language, enabling fast insights.
  • All the core data elements needed to support COVID-19 research and surveillance have a home in the PCORnet CDM. The goal for PCORnet is to characterize the cohort of COVID-19 patients and provide detailed information on demographics and pre-existing conditions.

Discussion Themes

Can PCORnet partners stand up a version of the CDM with more up-to-date information to allow for a faster characterization of the PCORnet COVID-19 population?

Is there a query to discover and address COVID-19 health disparities and social determinants of health?

Can PCORnet and NCATS’ National COVID Cohort Collaborative (N3C) work together?

Read more about PCORnet’s code lists and case definitions on GitHub.

Tags

#COVID19, #pctGR, @Collaboratory1

May 18, 2020: Two New Sections in the Living Textbook Describe Incentives for Sharing Data Sets and Preparing for Data Sharing

Posted on by Karen Staman

Drs. Adrian Hernandez, Greg Simon, and Rich Platt of the NIH Collaboratory have authored two new sections of the Living Textbook as part of an ongoing commitment to sharing resources and data.

  • Incentive Structure and Citations for Data Sets
    • This section calls for a revision of the appointment, promotion, and tenure (APT) process to incorporate effective data sharing into decision-making and to recognize and credit creators of data sets that gain meaningful use by others.
  • Preparing for Data Sharing
    • This section describes how to prepare for data and resource sharing throughout the embedded PCT (ePCT) lifecycle, including during grant submission, trial registration, conduct, and dissemination.

All NIH Collaboratory Trials are expected to share data and resources, such as protocols, consent documents, public use datasets, computable phenotypes, and analytic code. During the onboarding process, NIH Collaboratory Trials are given a Data and Resource Sharing Informational Document and an Onboarding Data and Resource Sharing Questionnaire to assist clinical investigators in developing data sharing plans. At closeout, NIH Collaboratory Trials are provided a Closeout Data and Resource Sharing Checklist and are expected to utilize this checklist to provide a final data share package.

For more on data sharing, see the Living Textbook chapter, Data Sharing and Embedded Research.

April 3, 2020: Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research (Harlan Krumholz, MD; Bala Hota, MD, MPH; Graham Nichol, MD, MPH)

Posted on by Gina Uhlenbrauck

Speakers

Harlan M. Krumholz, MD
Harold H. Hines Jr. Professor of Medicine, Yale University
Director, Yale New Haven Hospital Center for Outcomes Research and Evaluation
Co-Founder Hugo Health

Bala Hota, MD, MPH
Professor of Internal Medicine, Rush University
Chief Analytics Officer, Rush University Medical Center

Graham Nichol, MD, MPH
Medic One Foundation Endowed Chair for Pre-hospital Emergency Care
Professor of Emergency Medicine
University of Washington

Other Panelists:

Jacqueline Rollin, Administrative Fellow
Rush University Medical Center

Wade Schulz, MD, PhD
Assistant Professor of Laboratory Medicine
Director, CORE Center for Computational Health

Matthew J. Thompson, MB, ChB, DPhil
Helen D. Cohen Endowed Professorship in Family Medicine
Professor of Global Health and Medicine, University of Washington

Deb R. Chromik, Participant Experience
Hugo Health

Dave Hutton, Product Lead
Hugo Health

Topic

Innovative Support for Patients with SARS-COV-2 Infections Registry (INSPIRE): Participant-Centered, Rapidly-Deployed, Digitally-Enabled Research

Keywords

Coronavirus; Virus pandemic; INSPIRE Registry; COVID-19 directed research program; SARS-COV-2; Longitudinal data; Hugo Health digital research platform

Key Points

  • In the face of the coronavirus pandemic, there is an urgent need for rapid knowledge generation and actionable insights. Evidence needed includes:
    • The number of cases, including milder ones
    • Risk factors and timing of transmission
    • Severity and attack rate
    • Risk factors for infection and severe outcomes, including death
    • Infectiousness timing and intensity
  • Patients must be considered part of the team; involved, engaged, and respected, with agency over their data.
  • To better understand the experience of people with COVID-19, Rush University Medical Center and Hugo health are piloting the COVID INSPIRE registry. INSPIRE is a rapidly-deployed, digitally-enabled, participant-centered platform to collect longitudinal data and facilitate observational and experimental studies.

Discussion Themes

Even with social distancing, the coronavirus is in a rapid escalation phase; this rapid pace has our attention.

People are interested in participating in research now more than ever. The call to action is to build a human-connected system that treats patients compassionately and supports patients in real time.

Are there existing systems that could be built on or adapted for COVID-19? Are there potential for linkages to other systems?

Tags
#pctGR, @Collaboratory1, @HMKYale, @BalaHota, @GrahamNichol

March 16, 2020: New Video Interviews Highlight NIH Collaboratory Data and Resource Sharing

Posted on by Karen Staman

Recently, the NIH Collaboratory Coordinating Center conducted a video interview with Drs. Wendy Weber, Cathy Meyers, and Lesley Curtis to discuss the NIH Collaboratory Data Sharing Policy, including special requirements for the NIH Helping to End Addiction Long-term (HEAL) Initiative projects, and tips for sharing data and resources.

“For all the Demonstration Projects, primary data sets should be made available with the publication of the primary results paper. The Collaboratory policy also recognizes that there are additional considerations that must be incorporated into the policy because data sets are derived from the electronic health records of partnering healthcare systems, and additional precautions might be relevant to making these data sets available.” —Cathy Meyers, MD

The PRISM (Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing) Demonstration Projects are part of the HEAL Initiative to address the national opioid crisis. The special requirements for these pragmatic trials include:

  • All publications must be open access so the public has immediate access to the results of the trials.
  • The underlying primary data must be shared through a repository, which will be set up for all of the projects funded through the HEAL Initiative.

To support sharing, the NIH Collaboratory Data and Resource Sharing Page on the Living Textbook holds links to datasets and data dictionaries, study tools, ethics and regulatory documentation, computable phenotypes and analytic code, data collection forms, study design papers, main outcomes papers, and other information from the Demonstration Projects that might be useful to others.

Demonstration Projects are given a Data and Resource Sharing Informational Document and an Onboarding Data and Resource Sharing Questionnaire during the onboarding process to assist clinical investigators in planning early for the sharing of these resources,. At closeout, Demonstration Projects are provided a Closeout Data and Resource Sharing Checklist, and investigators from the completed projects use this checklist to provide a final data sharing package.