Neuroscience

NIH Comment Deadline: Draft Data Management and Sharing Policy and Supplemental Guidance

The National Institutes of Health (NIH), Office of Science Policy, seeks public comments on a draft policy and supplemental draft guidance on data management and sharing. The purpose of this draft policy and supplemental draft guidance is to promote effective and efficient data management and sharing to further NIH's commitment to making the results and accomplishments of the research it funds and conducts available to the public.

NIH's mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability. Sharing scientific data advances this mission by enhancing NIH's stewardship of taxpayer funds and maximizing research participants' contributions. Moreover, increasing access to scientific data resulting from NIH-funded or conducted research advances biomedical research by enabling the validation of scientific results, allowing analyses to be strengthened by combining data, facilitating reuse of hard-to-generate data, and accelerating future research.

Members of the public may submit comments online at this NIH website. More information is available at this Federal Register notice and at this NIH website.

NASEM Meeting: Standing Committee to Advise the US Department of State on Unexplained Health Effects on US Government Employees and their Families at Overseas Embassies

The National Academies of Sciences, Engineering, and Medicine (NASEM), Board on Global Health, will hold a data gathering meeting of its Standing Committee to Advise the US Department of State (DOS) on Unexplained Health Effects on US Government Employees and their Families at Overseas Embassies. The standing committee will provide a public forum to review the current medical investigations through presentations by lead scientific researchers closely affiliated with these cases. 

Since 2016 there have been reports of unexplained health effects on US Government employees and their families who were working at overseas embassies. While the scientific community is still deciphering the possible causes for these health effects, determining these causes and preventing future cases has remained a pressing DOS priority.

In order to facilitate the Department of State in implementing its responsibility to protect US government employees and their family members overseas, the Health and Medicine Division of the National Academies of Sciences, Engineering, and Medicine has formed a Standing Committee to Advise the US DOS on Unexplained Health Effects on US Government Employees and their Families at Overseas Embassies. The standing committee will evaluate current DOS practices for pre- and post-assignment health screening, provide expertise on potential epidemiologic studies, help with characterizing and understanding the current cases of potential trauma, and develop a  better understanding of possible causes of these cases and approaches for future incidents whether of an apparent acoustic nature or a different environmental or clinical presentation. The standing committee will also keep DOS abreast of any emerging concerns, interventions, and protective measures as these come available.

Members of the public may attend in person with advance registration. More information is available at this NASEM website.

CDC Comment Deadline: Data Calls for the Laboratory Response Network

The Centers for Disease Control and Prevention (CDC) seeks public comment on a proposed data collection activity titled "Data Calls for the Laboratory Response Network." This project is for data collected from its members concerning their capacity to respond to public health emergencies.

The Laboratory Response Network (LRN) was established by the Department of Health and Human Services, CDC, in accordance with Presidential Decision Directive 39, which outlined national anti-terrorism policies and assigned specific missions to Federal Departments and agencies. The Administration has stated that it is the policy of the United States to use all appropriate means, to deter, defeat, and respond to all terrorist attacks on our territory and resources, both with people and facilities. The LRN's mission is to maintain an integrated national and international network of laboratories that can respond quickly to suspected acts of biological, chemical, or radiological terrorism, emerging infectious diseases, and other public health threats and emergencies.

Members of the public may submit comments online at Regulations.gov, or by mail. More information is available at this Federal Register notice.

NIH Event: NCATS Day 2019

The National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS), will hold its 2019 NCATS Day. Agenda items include updates from NCATS, a panel discussion on sharing scientific data, and networking opportunities.

The collection and analysis of data is important for translating research results into new prevention strategies and treatments, that can improve human health. Sharing of scientific data helps validate research results, enables researchers to combine data types to strengthen analyses, facilitates reuse of hard to generate data or data from limited sources, and contributes to ideas for future research directions. Central to data sharing is the recognized need to make it as available as possible while ensuring the confidentiality and autonomy of research participants.

NCATS is committed to placing patients and their communities at the center of all our efforts and constantly looks for opportunities to include the patient perspective. At NCATS Day 2019, NCATS will discuss data sharing from different viewpoints, including the research participant, community, researcher, federal funder, and industry. It is important to hear different perspectives and participate in a dialogue that includes stakeholders from diverse backgrounds.

Members of the public may attend in person or via webcast with advance registration by December 10, 2019. More information is available at this NIH website.

HRSA Comment Deadline: Evaluation of the Pediatric Mental Health Care Access Program and the Maternal and Child Health Bureau Screening and Treatment for Maternal Depression and Related Behavioral Disorders Program

The Health Resources and Services Administration (HRSA), Maternal and Child Health Bureau, seeks public comment on two proposed data collection projects, evaluations of the Pediatric Mental Health Care Access Program and the Maternal and Child Health Bureau Screening and Treatment for Maternal Depression and Related Behavioral Disorders Program. These programs aim to increase identification of behavioral health conditions by screening specified populations (e.g., children, adolescents, young adults, and pregnant and postpartum women, especially those living in rural, isolated, and underserved areas); providing clinical behavioral health consultation; care coordination support (e.g., communication/collaboration, accessing resources, referral services) and training to health care providers; and increasing access to clinical interventions including by telehealth. Provider education and training will support the knowledge and skills acquisition needed to accomplish this goal.

 In order to evaluate progress made toward the programs' goals, this data collection will use four instruments: Health Care Provider (HCP) Survey, Practice-Level Survey, Program Implementation Survey, and Program Implementation Semi-Structured Interview. This information is needed to evaluate the programs by providing HRSA with the necessary information to guide future policy decisions regarding increasing health care providers capacity to address patient's behavioral health and access to behavioral health services. Specifically, data collected for the evaluation will be used to study the efforts of awardee programs to achieve key awardee outcomes (e.g., increase in access to behavioral health services; providers trained; available community-based resources, including counselors or family service providers) and to measure whether and to what extent awardee programs are associated with changes in these key awardee outcomes. The evaluation will also examine changes over time, within a state and/or across the programs, with regard to (1) enrolled providers/practices related to screening, referral, and care coordination for behavioral health conditions; (2) provision of behavioral health services for mental health conditions in primary care settings by enrolled health care providers; (3) use of consultative services; and (4) facilitation of access to behavioral health services for mental health conditions.

Members of the public may submit comments by email or mail. More information is available at this Federal Register notice.

NIH Webinar: Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance

The National Institutes of Health (NIH), Office of Science Policy, will hold an informational webinar on the Draft NIH Policy for Data Management and Sharing and Supplemental Draft Guidance. The purpose of this webinar is to provide information on the draft policy and answer any clarifying questions about the public comment process. 

Members of the public may attend the webinar. More information is available at this NIH website.

FDA Workshop: Developing Novel Therapies for Stimulant Use Disorder

The Food and Drug Administration (FDA), in partnership with the Duke University Margolis Center for Health Policy, will hold a workshop titled "Developing Novel Therapies for Stimulant Use Disorder." 

In recent years, there has been an increase in the number of overdoses that involve a psychostimulant, such as methamphetamine, cocaine, or prescription. In response to growing rates of stimulant misuse, addiction, and overdose, stakeholders across the US health care system are working to implement strategies designed to ensure that patients with stimulant use disorder are treated appropriately. For public policy, regulatory, and clinical decision-makers, understanding the shifting trends in addiction is critical to improving patient health outcomes and public health. Currently, there are no pharmacological treatments approved by the FDA stimulant use disorder. New therapies are needed to address treatment gaps for patients with stimulant use disorder.

Through a cooperative agreement with the FDA, this public workshop will examine the complexities of stimulant use disorder with a focus on methamphetamine and cocaine abuse. The goals of this workshop are to explore emerging trends in illicit and prescription stimulant abuse, review drug development paradigms for novel treatments, and explore potential innovative therapies for stimulant use disorder. Participants will discuss future directions for drug development and regulation as well as strategies for patient engagement. This meeting will bring together experts and key stakeholders from federal agencies, academia, and professional organizations. This workshop will lay the groundwork for understanding this complex landscape and promoting the exchange of innovative ideas to advance the development of novel therapies for stimulant use disorder.

Members of the public may attend in person with advance registration. More information is available at this FDA website.

SAMHSA Teleconference: Interdepartmental Serious Mental Illness Coordinating Committee

The Substance Abuse and Mental Health Services Administration (SAMHSA) will hold a teleconference meeting of its Interdepartmental Serious Mental Illness Coordinating Committee (ISMICC). The meeting will include information on federal efforts related to serious mental illness (SMI) and serious emotional disturbance (SED); including updates on the following focus areas: Data, Access and Engagement, Treatment and Recovery, Justice, and Finance; and discussion on Pediatric Behavioral Health Federal Work.

The ISMICC was established on March 15, 2017, in accordance with section 6031 of the 21st Century Cures Act, and the Federal Advisory Committee Act, 5 U.S.C. App., as amended, to report to the Secretary, Congress, and any other relevant federal department or agency on advances in SMI and SED, research related to the prevention of, diagnosis of, intervention in, and treatment and recovery of SMIs, SEDs, and advances in access to services and support for adults with SMI or children with SED. In addition, the ISMICC will evaluate the effect federal programs related to serious mental illness have on public health, including public health outcomes such as (A) rates of suicide, suicide attempts, incidence and prevalence of SMIs, SEDs, and substance use disorders, overdose, overdose deaths, emergency hospitalizations, emergency room boarding, preventable emergency room visits, interaction with the criminal justice system, homelessness, and unemployment; (B) increased rates of employment and enrollment in educational and vocational programs; (C) quality of mental and substance use disorders treatment services; or (D) any other criteria as may be determined by the Secretary. Finally, the ISMICC will make specific recommendations for actions that agencies can take to better coordinate the administration of mental health services for adults with SMI or children with SED. 

Members of the public may attend the teleconference. More information is available at this Federal Register notice.

FDA Workshop: Medication Adherence: Landscape, Strategies, and Evaluation Methods

The Food and Drug Administration, in collaboration with the Robert J. Margolis, MD, Center for Health Policy at Duke University, will hold a workshop titled "Medication Adherence: Landscape, Strategies, and Evaluation Methods." This public meeting will explore the state of the science of clinical research evaluating medication adherence involving FDA-regulated products.

Medication adherence—the extent to which patients take medications as prescribed in agreement with their health care provider—is an ongoing public health priority. Although the prevalence of medication non-adherence varies by disease and condition, increased adherence can improve health and reduce economic burden. Numerous strategies, including innovative tools and technologies, are used to assess and enhance medication, with variable success. 

Specific topics include:

  • Current landscape of interventions intended to (a) track (monitor) medication adherence, (b) improve medication adherence, and (c) improve clinical outcome(s) due to increased medication adherence;
  • Measurements of medication adherence; and
  • Study designs to evaluate the effectiveness of FDA-regulated products intended to track and/or improve medication adherence, with or without an association to clinical outcomes.

Members of the public may attend in person with advance registration, or via webcast. More information is available at this FDA website.

AHRQ Comment Deadline: Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression

The Agency for Healthcare Research and Quality (AHRQ) is seeking public comments on a proposed data collection titled "Outcome Measure Harmonization and Data Infrastructure for Patient Centered Outcomes Research in Depression." 

On November 6, 2019 (84 FR 59811), AHRQ extended the comment deadline from October 21, 2019, to December 6, 2019. 

AHRQ funded a prior project to harmonize the outcome measures collected across patient registries and routine clinical practice, with the goals of supporting the development of a robust data infrastructure that can consistently and efficiently collect high-quality data on outcome measures that are relevant to patients and clinicians and supporting patient-centered outcomes research and quality improvement. Harmonized outcome measures would also form the foundation for learning healthcare systems. Of note, AHRQ has supported the development of the Outcome Measures Framework (OMF). The OMF is a conceptual model for classifying outcomes that are relevant to patients and providers across most conditions. AHRQ, in collaboration with the US Food and Drug Administration and the National Library of Medicine, recently supported an effort to use the OMF as a content model for developing harmonized outcome measures in specific disease areas, including depression.

Major depressive disorder (MDD) is a common mental disorder that affects an estimated 16.2 million adults and 3.1 million adolescents in the United States. Characterized by changes in mood, cognitive function, and/or physical function that persist for two or more weeks, MDD can reduce quality of life substantially, impair function at home, work, school, and in social settings, and result in increased mortality due to suicide. MDD also is a major cause of disability, with an economic burden of approximately $210.5 billion per year in the United States.

Despite the burden of MDD and the availability of treatment, the condition is often undiagnosed and untreated. In 2016, the U.S. Preventive Services Task Force recommended screening for depression in the general adult population, including pregnant and postpartum women, and in adolescents. While routine screening is intended to improve diagnosis and treatment of MDD, many questions remain, such as about the comparative effectiveness of different treatment approaches, the incidence of adverse events, when to add medications for patients who do not respond to an initial course of treatment, how and why depression recurs, and how to classify and treat treatment-resistant depression. Patient registries capture a wealth of data on depression treatment patterns and outcomes in the United States and could serve as the foundation for a national research infrastructure to address these and other research questions. Yet, a lack of harmonization in the outcome measures collected by each registry makes it challenging, if not impossible, to link and compare data across registries and related efforts. As documented in the prior project, existing registries use different outcome measures (e.g., remission as defined by the PHQ-9 vs. HAM-D) and capture data at different timepoints.

Depression registries offer an excellent opportunity to demonstrate the feasibility and value of implementing the harmonized outcome measures. Existing registries already capture some of the harmonized depression measures for quality reporting, although at different timepoints; capture of these measures and the additional measures at consistent intervals will enable the registries to generate more robust data suitable for research purposes.

AHRQ is now proposing to implement the harmonized depression outcome measures developed under the prior project in two patient registries (the PRIME Registry and PsychPRO) and a health system setting. The purpose of this project is to demonstrate that capturing the harmonized outcome measures in the clinical workflow and submitting these data to different registries can improve clinical care, reduce the burden of registry participation, and increase the utility of registry data for research purposes. The objectives of the project are to:

  • Demonstrate that collection of the harmonized outcome measures is feasible, sustainable, and useful for clinicians participating in primary care and mental health patient registries.
  • Demonstrate that collection of the harmonized outcome measures is feasible, sustainable, and useful for clinicians in a health system setting.
  • Evaluate whether collection of the harmonized measures increases the utility of registry data for research purposes.

Members of the public may submit comments by email. More information is available at this Federal Register notice.

NASEM Meeting: Science and Innovation Leadership for the 21st Century: Challenges and Strategic Implications for the United States

The National Academies of Sciences, Engineering, and Medicine, Board on Science, Technology, and Economic Policy, will hold a meeting of its project titled "Science and Innovation Leadership for the 21st Century: Challenges and Strategic Implications for the United States." Items on the agenda for the public session of the meeting include introductory remarks from the co-chairs and presentations by four invited speakers. 

This ad hoc committee, under the auspices of the Board on Science, Technology, and Economic Policy in cooperation with the Committee on Science, Technology, and Law (CSTL), will explore the implications of the loss of US economic capability and leadership relative to other countries on issues such as national security, unemployment or underemployment of the US. workforce, and international development and global stability. The committee will convene a series of public workshops to help gather information and produce a consensus report with findings and recommendations to: 1) draw attention to the most overlooked challenges, based on current research on US competitiveness and trade, technology, and innovation policies; 2) develop a future agenda for needed research in areas that have not been fully explored; 3) identify current government infrastructure that hinders the United States' ability to address these challenges; and 4) produce recommendations for the federal government to effectively meet these challenges.

Members of the public may attend in person. More information is available at this NASEM website.

FDA Workshop: Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making

The Food and Drug Administration (FDA) will hold a workshop titled "Patient-Focused Drug Development: Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making." The FDA intends the workshop to gather input from the wider community of patients, patient advocates, academic researchers, expert practitioners, drug developers, and other stakeholders. The workshop will address a range of issues and considerations related to the collection and analysis of clinical outcome assessment (COA) data for drug development and regulatory decision making.

The purpose of this public workshop is to obtain feedback from stakeholders on considerations for:

  1. Endpoint development
  2. Estimands and analysis models
  3. Addressing heterogeneity in disease symptoms and functional status between patients and within the same patient over time
  4. Data collection, storage, transmission, and analysis

This public workshop is intended to support FDA implementation of requirements for guidance development under section 3002 of the 21st Century Cures Act (Pub. L. 114-255) and to meet a performance goal included in the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). Section 3002 of Title III Subtitle A of the 21st Century Cures Act directs FDA to develop patient-focused drug development guidance to address several areas including methodologies, standards, and technologies to collect and analyze COA data for purposes of regulatory decision making.

In addition, FDA is committed to meet certain performance goals under PDUFA VI. As part of the FDA Reauthorization Act of 2017 signed by the President on August 18, 2017, PDUFA VI includes a number of performance goals and procedures that are documented in the PDUFA VI Commitment Letter.

Members of the public may attend in person with advance registration, or via webcast. More information is available at this FDA website.