June 7, 2018: NIH Releases First Strategic Plan for Data Science

On June 4, the National Institutes of Health (NIH) released its first Strategic Plan for Data Science. The plan outlines steps the agency will take to modernize research data infrastructure and resources and to maximize the value of data generated by NIH-supported research.

Data science challenges for NIH have evolved and grown rapidly since the launch of the Big Data to Knowledge (BD2K) program in 2014. The most pressing challenges include the growing costs of data management, limited interconnectivity and interoperability among data resources, and a lack of generalizable tools to transform, analyze, and otherwise support the usability of data for researchers, institutions, industry, and the public.

The goals of the NIH Strategic Plan for Data Science are to:

  • support an efficient, effective data infrastructure by optimizing data storage, security, and interoperability;
  • modernize data resources by improving data repositories, supporting storage and sharing of individual data sets, and integrating clinical and observational data;
  • develop and disseminate both generalizable and specialized tools for data management, analytics, and visualization;
  • enhance workforce development for data science by expanding NIH’s internal data science workforce and supporting expansion of the national research workforce, and by engaging a broader community of experts and the general public in developing best practices; and
  • enact policies that promote stewardship and sustainability of data science resources.

As part of the implementation of the strategic plan, the NIH will hire a chief data strategist. For information about the position, see the job announcement.

April 27, 2018: Collaboratory Investigators Pen Editorial Calling for Pragmatic Trials of Nonpharmacologic Dementia Interventions

NIH Collaboratory investigators Dr. Susan Mitchell and Dr. Vincent Mor coauthored an editorial for an upcoming issue of JAMDA highlighting the need for pragmatic trials of nonpharmacologic interventions in Alzheimer disease and related dementias. The editorial summarizes conclusions from a recent workshop at the National Institute on Aging (NIA), where experts discussed the state of the science for pragmatic trials to improve dementia care.

The goals of the NIA workshop were (1) to identify criteria for determining the readiness of dementia interventions for pragmatic trials, and (2) to describe the research infrastructure needed to support such trials.

Read the full editorial: Identifying and Supporting Nonpharmacological Dementia Interventions Ready for Pragmatic Trials: Results From an Expert Workshop

Drs. Mitchell and Mor are co-principal investigators of the NIH Collaboratory’s Pragmatic Trial of Video Education in Nursing Homes (PROVEN), which is evaluating the effectiveness of advance care planning video tools in nursing home settings. The editorial mentions that a supportive infrastructure for pragmatic research in dementia could be modeled after the NIH Collaboratory’s Coordinating Center, including Core Working Groups “focused on building investigator capacity, supporting pragmatic trial design, and maintaining the resource and knowledge base.”

Full citation: Baier RR, Mitchell SL, Jutkowitz E, Mor V. Identifying and supporting nonpharmacological dementia interventions ready for pragmatic trials: results from an expert workshop. J Am Med Dir Assoc. doi: 10.1016/j.jamda.2018.02.011.

April 13, 2018: PCORI Launches Tool for Exploring Literature on Engagement in Health Research

Seeking to advance the study and practice of engagement in health research, the Patient-Centered Outcomes Research Institute (PCORI) recently launched the Engagement in Health Research Literature Explorer. Locating relevant research articles about engagement can be challenging because of a lack of standard terminology. The new tool searches a curated database of peer-reviewed literature on engagement. Articles are included in the database if they describe engagement experiences, report research findings on engagement practices, or present theories, concepts, or views on engagement. The database is updated monthly and is one way PCORI is helping to promote meaningful involvement of patients, caregivers, clinicians, and other healthcare stakeholders throughout the research process.

Read more information about the explorer tool and how it was developed.

You can also learn more about stakeholder engagement in the Living Textbook chapter.

February 20, 2018: National Academies Release Workshop Summary on Real-World Evidence in Medical Product Development

The National Academies of Sciences, Engineering, and Medicine released a summary of the first workshop in a 3-part series on the development and use of real-world evidence in medical product development. The report, Examining the Impact of Real-World Evidence on Medical Product Development: I. Incentives, focuses on the role of incentives in supporting the collection and use of real-world evidence in product review, payment, and delivery.

In clinical research, data from observational studies, registries, claims, safety surveillance, and other sources are increasingly recognized as valuable supplements to randomized controlled trials. The 3-part workshop, sponsored by the US Food and Drug Administration, is intended to “advance discussions and common knowledge about complex issues relating to the generation and utilization of real-world evidence.”

NIH Collaboratory investigators Dr. Gregory Simon and Dr. Richard Platt served on the planning committee for the workshop series. Dr. Simon opened Workshop 1 by summarizing the core qualities of real-world evidence. Dr. Platt presented lessons from the Sentinel Initiative, an example of the successful use of real-world evidence to answer questions of efficacy and effectiveness.

The second workshop in the series, “Practical Approaches,” will explore what types of data are appropriate for which purposes and will recommend practical approaches for data collection. Registration for Workshop 2 is open now.

January 31, 2018: NIH Collaboratory Launches Monthly Email Newsletter

The NIH Collaboratory is pleased to announce the launch of its new monthly email newsletter. The newsletter offers a convenient monthly wrap-up of NIH Collaboratory news, along with featured stories and a look at what’s coming in the month ahead. Every newsletter will contain useful tips for investigators and links to resources for pragmatic clinical trials.

The inaugural January issue of the newsletter includes recent news about training opportunities and regulatory requirements, Grand Rounds and podcast highlights, a spotlight on the Trauma Survivors Outcomes and Support (TSOS) trial, and more.

Read the January newsletter and subscribe to future issues of the newsletter.

January 10, 2018: NCI Announces Training Institute in Dissemination and Implementation Research in Cancer

The National Cancer Institute’s Division of Cancer Control & Population Sciences is accepting applications for a Training Institute in Dissemination and Implementation Research in Cancer (TIDIRC). Designed for investigators at all levels who conduct dissemination and implementation research in cancer control, the training institute will consist of a 4-month online course and a 2-day in-person training.

There are no costs associated with the training institute, though applicants who are accepted into the program must cover travel-related expenses for the in-person meeting in Bethesda, Maryland.

This cancer-focused training program is adapted from a broader curriculum offered in previous years, the Training Institute in Dissemination and Implementation Research in Health (TIDIRH). Read an article in Implementation Science about the development of the program: “The U.S. Training Institute for Dissemination and Implementation Research in Health.”

The application window for the training institute will close on February 9, 2018. Read the announcement and submit an application: https://cancercontrol.cancer.gov/IS/training-education/tidirc/index.html.