August 3, 2023: NCI’s David Chambers Discusses Role of Implementation Science in Pragmatic Research

This year’s Annual Steering Committee Meeting for the NIH Pragmatic Trials Collaboratory featured implementation science as one of the topics of focus. In an interview after his keynote presentation, Dr. David Chambers, deputy director for implementation science at the National Cancer Institute, shared his thoughts on opportunities for implementation science in the context of pragmatic trials.

Why Implementation Science Is Important in Pragmatic Research

Chambers described the overlap between implementation science and pragmatic research and how this creates several benefits. Implementation science gives a heightened focus on how to get interventions to be as accessible, well used, and beneficial as possible to populations within the systems and communities in which people are seeking and receiving healthcare.

“The earlier researchers can think about their interventions being used beyond the trial, the better,” Chambers explained. “Implementation science helps to provide a lens for multiple levels of change that may be needed, including supports for patients and families, clinicians, clinics, systems, policymakers, and other key decision-makers.”

Furthermore, implementation science methods can save time in identifying barriers and facilitators for delivering interventions with high quality-knowledge which can be applied toward the ultimate use of interventions.

Chambers encourages researchers to embrace the dynamism that is reflected in our health systems, which is particularly apt for research conducted in the setting of routine care. “It is a given that there will be deviations from the design of an intervention and its implementation, so how can researchers learn from this?” he said.

In terms of sustaining an intervention, a more dynamic approach is needed to how the intervention and the context will change over time, he explained. “Too often we think of sustainment in terms of fixing things in their original state. Sustainment needs to think about how to build in evolution-medicine and our practices are evolving.”

Role of the NIH Pragmatic Trials Collaboratory

According to Chambers, the NIH Pragmatic Trials Collaboratory provides a natural setting for implementation activities because of the close partnerships between the investigative teams and the health systems and community settings where the research occurs. As a result, the program is poised for ongoing learning from the strategies health systems are using to implement a range of different interventions.

There is also an opportunity for pooling lessons across the NIH Collaboratory Trials, such as common measures that can be used to better characterize adaptation, understanding perspectives and needs of patients and clinicians, and approaches related to long-term sustainment or deimplementation of interventions.

Increasingly for NIH Collaboratory trials, issues related to implementation are baked into both the design of interventions and the approach used to test the interventions, which is a testament to the program’s ongoing progress in encouraging the use of implementation science concepts and methods.

Learn more about the NIH Collaboratory’s Implementation Science Core.

How NIH Is Advancing Implementation Science

For over 20 years, NIH has recognized the gaps in knowledge needed for successful implementation of evidence-based interventions. Across NIH institutes, centers, and offices, they have discussed the common challenges observed when investigators saw a positive result in their trial and were frustrated that it could not be replicated and scaled up in the real world.

NIH funds dissemination and implementation research grants and has a standing review panel, the Science of Implementation in Health and Healthcare, focused on this area where any applicant to NIH can suggest that their grant be reviewed. In addition, NIH supports training opportunities in the field and cohosts an annual scientific conference in partnership with AcademyHealth.

NIH continues to explore the interface between effectiveness and implementation, think about deimplementation, and work on tackling misinformation, all towards advancing how to better apply the evidence generated in research to optimize population health and healthcare.

June 22, 2023: Taunton Paine Discusses New NIH Data Sharing Policy at Annual Steering Committee Meeting

Photo of Taunton Paine
Taunton Paine, Director of the NIH Scientific Data Sharing Policy Division

At the annual NIH Pragmatic Trials Collaboratory Steering Committee meeting in May, we interviewed Taunton Paine, director of the NIH Scientific Data Sharing Policy Division, about the NIH’s new Data Management & Sharing Policy, which took effect in 2023.

Under the new policy, all NIH-funded research requires a submission plan that describes how, where, and when data will be shared.

“We want to advance the rigor and reproducibility of research and promote public trust in research,” Paine said. He highlighted some key points to help researchers comply with the new policy:

  • Scope: The policy applies to all NIH-supported research generating scientific data of sufficient quality to validate and replicate research.
  • When: Share data no later than publication or end of award (for data underlying findings not published in peer-reviewed journals).
  • Where: For suggested repositories, see NIH-supported data repository list. It is also acceptable to use other repositories.

“The number  one thing I would recommend for investigators is to look at sharing.nih.gov for guidance on how to write a data management and sharing plan, example plans, guidance about repositories, and frequently asked questions,” Paine said.

One key difference between the new policy and the 2003 Data Sharing Policy is that there is much more guidance and support.

“The new data management and sharing policy has a lot more guidance about what we are asking people to do and what’s acceptable. It also has information about  monitoring and compliance mechanisms,” Paine said

NIH Pragmatic Trials Collaboratory leadership advocated for data sharing in an article in the Annals of Internal Medicine, suggesting that data sharing is not rising to its potential. At the Steering Committee meeting, investigators from the NIH Collaboratory Trials reviewed their trials’ data sharing plans and discussed potential barriers, a process that the program has used to bring planning for data sharing to the forefront.

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

In the coming weeks, we will share more interviews with program leaders from the 2023 Steering Committee meeting. All of the materials from the 2023 Steering Committee meeting are now available.

Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)

Speaker

Stacey J. Adam, PhD
Associate Vice President, Research Partnerships
Foundation for the NIH

 

 

Keywords

ACTIV, COVID-19, FNIH

 

Key Points

  • The normal timeline for public-private partnerships is around 9 months of planning. ACTIV was stood up in about a month, launching on April 17, 2020, to develop a coordinated research response to speed COVID-19 treatment and vaccine options. There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical.
  • In the therapeutics arm, the most promising therapeutic agents for COVID-19 were prioritized. Candidate agents were triaged based on concurrent clinical trials, completion of a multiple ascending dose study, and availability of preclinical data before being scored based on predefined criteria. From this review, 11 ACTIV master protocols were developed.
  • Having the ability to use the resources from the public and private sectors as much as possible, having sufficient funding and staffing, and having clear communication were all quintessential to getting things running quickly.
  • Since the protocols have launched, 20,000+ patients have enrolled at more than 620 sites across numerous networks, 11 protocols were developed, 10 launched, with 26 publications across 13 journals. The team reviewed 800 candidates over 2 years time. We selected 35 and completed testing of 27 of them. Six agents showed really good results and either changed clinical practice or showed efficacy and improved patient care. Five agents are still in testing.
  • Each protocol has had many lessons learned. Across all is the need for clear communication, resources, and partnerships.

Discussion Themes

How did the public-private partnership contributed to the success of ACTIV? Having the companies at the table, bringing the resources (man power, willingness to test, openness of conversation) was amazing and contributed to success of the program.

Foundation for NIH was involved from the beginning because we had successfully done the public-private partnerships for other initiatives, we had the stakeholder relationships to get everyone to the table, and our involvement allowed for rapid, targeted donations from private sector.

 

Read more in Annals of Internal Medicine and Critical Care Medicine.

View the Summary of NIH-Funded ACTIV/ACTIV-Associated Clinical Trials.

Tags

#pctGR, @Collaboratory1

February 18, 2022: Building a Resource: The Process of Developing a Trans-stakeholder Framework to Enable Pediatric Drug Development (Perdita Taylor-Zapata, MD)

Speaker

Perdita Taylor-Zapata, MD
Best Pharmaceuticals for Children Act (BPCA) Program Lead and NICHD Program Officer
Obstetric and Pediatric Pharmacology and Therapeutics Branch
National Institute of Child Health and Human Development

Keywords

NIH Best Pharmaceuticals for Children Act; Pediatric Trial Network; Trial design; Pediatric drug development

Key Points

  • The current model for pediatric drug development can be slow and neglect neonates and rare pediatric conditions.
  • The NIH Best Pharmaceuticals for Children Act (BPCA) allows the NIH to conduct clinical trials with off-patent drugs in children.
  • Goals of the BPCA program include developing novel trial designs and including diverse and understudied populations.
  • A new framework to enable pediatric drug development could identify resources to assist in drug development, identify areas in need of further research, provide a pathway for integrating approaches, and connect pediatric researchers.
  • The BPCA went through a rigorous systematic approach to develop a comprehensive resource listing for best practices for pediatric drug trials.

Discussion Themes

Most data collected through the opportunistic model presented is PK data to determine dosing so that a more traditional drug trial can be conducted in the future.

With the right infrastructure in place, such as the Pediatric Trials Network, can substantially improve time to conduct trials.

 

Read more about the BPCA and their commitment to diversity in pediatric drug trials.

 

Tags

#pctGR, @Collaboratory1

Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)

Inclusion of Diverse Participants in Pragmatic Clinical Trials: NIH-Hosted Workshop (May-August 2021)

A workshop focused on the inclusion of diverse participants in pragmatic clinical trials with insights about planning for diversity, engaging participants, learning from implementation science to maximize diversity, and developing a pipeline of diverse investigators

October 20, 2020: All of Us Research Program Issues Funding Opportunity for New Engagement Partners

The All of Us Research Program has issued a new funding opportunity seeking partnerships with national, state, and local engagement partners to recruit and engage participants in the landmark NIH program. Through these partnerships, All of Us aims to create bidirectional and co-equal relationships that engage communities that have historically been underrepresented in biomedical research.

Logo for the All of Us Research Program

All of Us, a historic effort to accelerate research and improve health, launched nationally in 2018 to create one of the most comprehensive and diverse biomedical data resources of its kind. More than 358,000 participants have enrolled in the program. This latest funding opportunity illustrates the program’s commitment to partnering with organizations that are influential in their respective communities, especially those organizations that work with diverse communities.

The program anticipates funding at least 6 awards in fiscal year 2021 through this latest funding opportunity, each with a total project period of 5 years. Applications are due on November 23, 2020.

All of Us encourages eligible applicants with experience working with and engaging underrepresented communities to apply for this funding. All of Us considers the following populations underrepresented in research: racial and ethnic minority groups; children and seniors; sexual and gender minorities; people living with disabilities; people with barriers in access to care; people who have low income or low educational attainment; and rural residents.

For full details regarding this opportunity, please see the funding announcement.

October 27-30: Simplifying Informed Consent – OHRP Virtual Workshop at the NIH Office of Extramural Research Fall Regional Seminar

The NIH Office of Extramural Research (OER) will host its semi-annual regional seminar virtually this fall from October 27-30. Registration is required, and the event is free.

Mark your calendars to join OHRP on Friday, October 30, 1:00-2:45pm EDT for an extended session about informed consent, including practical tips on integrating the revised Common Rule requirements into your consenting processes.

And don’t miss a special Q&A with OHRP session on Tuesday, October 27, 3:00-4:00pm. Once registered for the regional seminar, find the link to attend the Q&A session under the NIH Human Subjects, Clinical Trials, and Inclusion Booth Events.

Registration and more information as is it available at: nihvirtualseminar2020.vfairs.com/

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

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.

March 16, 2020: NIH Announces Guidance for Clinical Trials Affected by COVID-19 Emergency

The NIH today announced new guidance describing the flexibility available to recipients who are conducting NIH-funded clinical trials or human subject studies affected by the COVID-19 public health emergency. The new guidance addresses the safety of research participants and research staff, delays in research progress, and unanticipated costs.

Last week, the NIH created a new public web page—Coronavirus Disease 2019 (COVID-19): Information for NIH Applicants and Recipients—to serve as a central location for information about application deadlines, proposal submission and award management, and flexibility available to applicants and recipients. The page also includes links to COVID-19 information from the NIH, the Centers for Disease Control and Prevention, and the World Health Organization. The web page will be updated as events require.

March 13, 2020: NIH Shares COVID-19 Guidance and Resources for Applicants and Recipients

A new public web page offers guidance and resources for NIH applicants and recipients in response to the COVID-19 public health emergency declared by the Secretary of Health and Human Services.

Information for NIH Applicants and Recipients includes information about application deadlines, proposal submission and award management, and flexibility available to applicants and recipients. The page also includes links to COVID-19 information from the NIH, the Centers for Disease Control and Prevention, and the World Health Organization.

The new web page will be updated as events require.