NIH

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

Posted on by Damon Seils

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

Posted on by Damon Seils

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.

January 9, 2020: NIH Collaboratory Investigators Respond to Draft NIH Policy on Data Sharing

Posted on by Karen Staman

NIH Collaboratory leadership and NIH Collaboratory Trial principal investigators, along with their colleagues, responded this week to the recently released Draft NIH Policy for Data Management and Sharing and supplemental draft guidance. The draft policy proposes that applicants for research funding submit a plan describing how scientific data will be managed and shared.

“We applaud the NIH’s policy and commitment to making the results and outputs of the research it funds and conducts available to the public. We enthusiastically support data sharing and agree with the principles of this policy. However, we believe more detail is warranted about the different types of research (ie, embedded pragmatic research), the associated protections, and acceptable mechanisms for sharing data, such as public and private archives and enclaves.” —Response to Draft NIH Policy for Data Management and Sharing

The main topics covered in the response are:

  • Support for the goals of the draft data sharing policy
  • Assessing and mitigating re-identification risk
  • Protecting secondary subjects
  • Use of data enclaves
  • Crediting those who share data

Other signatories include participants in the National Academy of Medicine’s Clinical Effectiveness Research Innovation Collaborative of the Leadership Consortium for Value and Science-Driven Health Care, and leaders of the Health Care Systems Research Network.

The full letter is available for download and includes the list of signatories.

Comments are due no later than January 10, 2020, and may be submitted online.

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

December 13, 2019: Reissuance of Funding Opportunity Announcement for HEAL Initiative/PRISM Coming January 2020

Posted on by Gina Uhlenbrauck

The National Center for Complementary and Integrative Health (NCCIH), with other NIH Institutes, Centers, and Offices, intends to reissue Funding Opportunity Announcement (FOA) HEAL Initiative: Pragmatic and Implementation Studies for the Management of Pain To Reduce Opioid Prescribing (PRISM) (UG3/UH3 Clinical Trial Optional).

This RFA solicits applications for phased cooperative research applications to conduct efficient, large-scale pragmatic or implementation trials to improve pain management and reduce the unnecessary use of opioid medications in the health care delivery setting. The re-issuance of the FOA will prioritize the following areas for pragmatic trials to integrate multimodal or multiple interventions that have demonstrated efficacy into health care systems or implement health care system changes to improve adherence to evidence-based guidelines:

  • Pain management in emergency departments, dental clinics, primary care, and hospitals
  • Chronic overlapping pain conditions
  • Pain management in individuals at risk of or with opioid use disorder
  • Pain management in those with co-occurring mental health disorders
  • Noncancer pain management in persons with medical comorbid conditions

The FOA is expected to be published in January 2020 with an expected application due date in March 2020.

The announcement is part of the NIH Heal (Helping to End Addiction Long-term) Initiative, which was created in April 2018 in an effort to speed scientific solutions for addressing the national opioid public health crisis.

 

November 22, 2019: NIH Releases Draft Policy for Data Management and Sharing

Posted on by Karen Staman

The NIH recently released a Draft NIH Policy for Data Management and Sharing and supplemental draft guidance for public comment.

In the draft, the NIH reiterates its commitment to making available the results and products of the research it funds, and acknowledges that data sets come from a variety of sources that may have unique data sharing concerns. Therefore, the draft policy proposes that applicants for research funding submit a plan describing how scientific data will be managed and shared.

 “Under this Policy, individuals and entities would be required to provide a Data Management and Sharing Plan (Plan) describing how scientific data will be managed, including when and where the scientific data will be preserved and shared, prior to initiating the research study.” —Draft NIH Policy for Data Management and Sharing

The elements of the Plan are described in detail in the Draft Policy and will require a description of data type and quantity, a rationale for decisions about data sharing, metadata and associated documentation, and plans for protecting confidentiality.

Comments are due no later than January 10, 2020. Comments may be submitted online.

For information on the NIH Collaboratory Data Sharing Policy, see the Data and Resource Sharing informational document, questionnaire, and checklist.

September 27, 2019: NIH Collaboratory to Serve as Coordinating Center for New Pragmatic Trials Addressing Opioid Crisis

Posted on by Gina Uhlenbrauck

The NIH Health Care Systems Research Collaboratory program is excited to announce that it has received funding to serve as the Resource Coordinating Center for a new group of large-scale embedded pragmatic clinical trials (ePCTs) on pain management and reducing opioid prescribing. As part of the NIH Collaboratory, the Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing (PRISM) Resource Coordinating Center will provide technical support and pragmatic trial expertise for the research that this program funds. PRISM trials will determine the effectiveness of multiple non-opioid interventions for treating pain and assess the impact of implementing interventions or guidelines to improve pain management and reduce reliance on opioids.

The PRISM Resource Coordinating Center funding and new research awards, described below, are part of the NIH’s Helping to End Addiction Long-term Initiative (NIH HEAL Initiative). This federal research initiative, launched in early 2018 by NIH Director Francis S. Collins, aims to apply scientific solutions to improve treatments for chronic pain, curb the rates of opioid use disorder and overdose, and achieve long-term recovery for opioid addiction.

“The NIH Collaboratory Coordinating Center is excited to be supporting these novel pragmatic trials that address an urgent health crisis. We hope the patients, clinicians, researchers, and health systems will benefit from knowledge we’ve gained supporting complex trials embedded in health care systems over the past 7 years, which will help deliver improvements in pain management to the American public faster.” – Adrian Hernandez, MD, MHS, Vice Dean for Clinical Research, Duke University School of Medicine.

The PRISM awards total approximately $35.7 million and are supported by 8 participating NIH institutes, centers, and offices. With these awards, the NIH Collaboratory will add 4 new large-scale ePCTs to its portfolio of innovative NIH Collaboratory Trials. The trials will be conducted at Boston Medical Center, Massachusetts; Kaiser Foundation Research Institute, California; Mayo Clinic, Minnesota; and University of Iowa. They include:

  • Non-pharmacological Options in postoperative Hospital-based And Rehabilitation pain Management (NOHARM) pragmatic clinical trial
  • Fibromyalgia TENS in Physical Therapy Study (TIPS): An embedded pragmatic clinical trial
  • Group-based mindfulness for patients with chronic low back pain in the primary care setting
  • Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults

The NIH Collaboratory aims to improve the way clinical trials are conducted by creating a new infrastructure for collaborative research with healthcare systems. The Collaboratory has 5 Core Working Groups of experts that help research teams address challenges of conducting research embedded in clinical care, and they collect and disseminate knowledge and best practices learned throughout the process. The ultimate goal is to ensure that healthcare providers and patients can make decisions based on the best available clinical evidence.

Related links:

NIH press release

Duke press release

NIH HEAL Initiative website

The Coordinating Center of the National Institutes of Health (NIH) Health Care Systems Research Collaboratory is supported by the NIH Common Fund through a cooperative agreement from the Office of Strategic Coordination within the Office of the NIH Director. Read more about the NIH Collaboratory Trials and the Core Working Groups.

November 12, 2018: Participate in the NIH Office of Disease Prevention’s Research Expertise Survey

Posted on by Gina Uhlenbrauck

The National Institutes of Health (NIH) Office of Disease Prevention (ODP) needs your help to enhance the quality of research supported by the NIH. The ODP is building a directory of experts in research methods and study designs that can help NIH Scientific Review Officers identify the most appropriate reviewers for NIH research applications. Adding your name and expertise to the directory is easy – simply share your methodological and content area expertise by filling out the ODP’s Prevention Research Expertise Survey (PRES).

 

The survey covers 7 areas related (but not limited) to prevention research:

  • Study Design Topics
  • Research Methods
  • Content Topics
  • Settings
  • Populations
  • Regions
  • Income Categories

The PRES takes approximately 15-25 minutes and is strictly voluntary. Based on your skill set and interest, NIH or Department of Health and Human Services (HHS) staff may invite you to serve as a peer reviewer for research applications, or you may be asked to sit on a panel, committee, or workgroup; or to speak at a seminar or workshop. Your responses and information will not be shared with anyone outside of HHS.

The ODP believes the participation of highly qualified methods experts will enhance the quality of peer review; improve the rigor, reproducibility, and impact of research supported by the NIH; and ultimately lead to stronger clinical practice, health policy, and community health programs.

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention and disseminating the results of this research to improve public health. For more information about the ODP and its work, visit the ODP website.

Thank you in advance for taking the survey – your participation helps improve the rigor, impact, and value of research supported by the NIH.

April 16, 2018: Registration Now Open for Workshop on Embedded Pragmatic Clinical Trials of Therapeutic A vs. B Interventions

Posted on by Karen Staman

Registration is now open for a one-day workshop sponsored by the NIH Common Fund and organized by NIH Collaboratory thought leaders. The workshop, to be held on May 16, will focus on expanding the understanding of a specific type of pragmatic trial, the A vs. B trial, which compares two or more distinct therapeutic medical interventions. Over the past 6 years, the NIH Collaboratory has launched NIH Collaboratory Trials that address questions of major public health importance in real-world settings with usual care as a control arm. Much has been learned about the design, conduct, and dissemination of pragmatic clinical trials through this work. As a next step, there is considerable excitement at the prospect of exploring pragmatic clinical trials for comparing medical interventions.

The workshop will include a series of moderated discussions of opportunities and approaches for partnering with healthcare systems, and other stakeholders, to conduct embedded A vs. B trials. Speakers will include representatives from NIH, FDA, OHRP, health systems, academia, and industry.

The workshop will take place from 8:00 AM – 4:15 PM ET on Wednesday, May 16. Participants can join in person at the Bethesda Marriott in Maryland or via webcast. Choose an option for attendance on the registration page.

The organizing committee for the workshop includes Adrian Hernandez & Richard Platt (Co-Chairs), Laura Dember, Susan Huang, Catherine Meyers, Wendy Weber, and Dave Wendler.

 

 

NIH & FDA seek feedback on new clinical trial protocol template

Posted on by Gina Uhlenbrauck

As part of their ongoing effort to improve the speed and efficiency of conducting clinical trials, the NIH-FDA Joint Leadership Council has created a draft clinical trial protocol template. The template contains instructional and sample text intended to assist NIH-funded investigators in writing protocols for phase 2 or 3 clinical trials that require Investigational New Drug (IND) or Investigational Device Exemption (IDE) applications. Feedback is sought from investigators, investigator-sponsors, institutional review board members, and other stakeholders involved in protocol development and review.

Our goal is to provide an organized way for creative investigators to describe their plans so that others can understand them. – Dr. Pamela McInnes, NIH

Details on the rationale and development of the protocol template are on these blog posts:

Notice Number: NOT-OD-16-043. Responses accepted through April 17, 2016.

You can access the template document as well as a template shell, comment form, and other resources at NIH’s Clinical Research Policy website.

NIH Issues Draft Policy Proposing Use of Single IRB for Multisite Clinical Research Studies

Posted on by Gina Uhlenbrauck

On December 3, 2014, the National Institutes of Health (NIH) issued a draft policy promoting the use of a single institutional review board (IRB) for multisite studies. IRBs play a critical role in assuring the ethical conduct of research, and studies must be reviewed and approved by an IRB before they can begin. Yet over time, the clinical research landscape has become increasingly complex, expanding from studies formerly conducted at single institutions to large, diverse studies across networks and multiple sites. This situation challenges the practicality of using local IRBs to conduct initial and ongoing reviews for such studies.

The goal of permitting use of a single IRB—also called a central IRB or IRB of record—is to enhance and streamline the process of IRB review for multisite studies so that research can proceed efficiently without compromising ethical principles and protections. While both the FDA and Office for Human Research Protections support the use of a single IRB, too few institutions involved in multisite studies are taking advantage of the option.

 Read the NIH draft policy here.

“By using single IRBs in multi-site studies, we reduce duplication of effort, speed the initiation of important research, and save time and taxpayer funds.”
Francis S. Collins, MD, PhD, NIH Director

Among the current NIH programs incorporating the use of a single IRB are:

  • National Cancer Institute’s Central Institutional Review Board (CIRB)
  • National Institute of Neurological Disorders and Stroke’s Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT)
  • Network for Stroke Research (NIH StrokeNet)

Dr. Sally Rockney, NIH deputy director for extramural research, explains the NIH perspective in her blog. Public comment on the draft policy extends for 60 days, through January 29, 2015. When finalized, the policy will apply to all NIH-funded multisite studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program.