Outline. Mission. NCCIH Research Priorities HSR Community Conference September 11, National Center for Complementary and Integrative Health

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NCCIH Research Priorities HSR Community Conference September 11, 2015 Wendy Weber, ND, PhD, MPH Chief, Clinical Research Branch, Division of Extramural Research Outline NCCIH Mission & Strategic Plan

1 NCCIH Research Priorities HSR Community Conference September 11, 2015 Wendy Weber, ND, PhD, MPH Chief, Clinical Research Branch, Division of Extramural Research Outline NCCIH Mission & Strategic Plan Funding Opportunities for Investigators Complementary Health Approaches Utilization in the US NCCIH Clinical Research Policies to Enhance Rigor and Reproducibility Framework for Developing & Testing Interventions Clinical Research Oversight Natural Product Integrity Clinical Research Toolkit and Resources Mission National Center for Complementary and Integrative Health To define, through rigorous scientific investigation, the usefulness and safety of complementary and integrative health interventions and their roles in improving health and health care Vision Scientific evidence informs decision making by the public, by health care professionals, and by health policymakers regarding use and integration of complementary and integrative health approaches 1

2 What is NCCIH? Federal Government's lead agency for scientific research on Complementary and Integrative Health Approaches 1 of 27 institutes/centers within the National Institutes of Health (NIH) Established in 1998 Annual appropriation - $124.1M (FY2015) What are Complementary Health Approaches? Many definitions, none perfect Group of diverse medical and health care interventions, practices, products, or disciplines that are not generally considered part of conventional medicine NCCIH Strategic Plan Strategic Objectives I. Advance Research on Mind and Body Interventions, Practices and Disciplines II. Advance Research on CAM Natural Products III. Increase Understanding of Real-World Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion IV. Improve the Capacity of the Field to Carry Out Rigorous Research V. Develop and Disseminate Objective, Evidence- Based Information on CAM Interventions Guiding Principles for NCCAM Natural Products Exploratory Research Necessary to understand biological effects and mechanisms of action Powerful high throughput tools and technologies should be actively pursued Important to elucidate relationships between natural products and host biology Needs for development of better tools and methods for plant characterization analysis 2

NCCAM Priorities for Mind and Body Clinical Trials Portfolio Focused and aligned with NCCAM Strategic Plan Conducted at the

timeframes and budgets Test hypotheses that will guide future research Outline NCCIH Mission & Strategic Plan Funding

Enhance Rigor and Reproducibility Framework for Developing & Testing Interventions Clinical Research Oversight Natural

3 NCCAM Priorities for Mind and Body Clinical Trials Portfolio Focused and aligned with NCCAM Strategic Plan Conducted at the appropriate stage based current evidence Statistically powered to assess clinically meaningful outcomes Propose realistic timeframes and budgets Test hypotheses that will guide future research Outline NCCIH Mission & Strategic Plan Funding Opportunities for Investigators Complementary Health Approaches Utilization in the US NCCIH Clinical Research Policies to Enhance Rigor and Reproducibility Framework for Developing & Testing Interventions Clinical Research Oversight Natural Product Integrity Clinical Research Toolkit and Resources Active Funding Opportunity Announcements 3

4 NCCIH Funding Opportunities Exploratory Clinical Trials of Mind and Body Interventions for NCCAM High Priority Research Topics (R34) PAR up to $450K (direct) over 3 years Biology of Manual Therapies (R21, R01) PA , PA Mechanisms, Models, Measurement, and Management in Pain Research (R01) PA Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01) PAR Research on Chronic Overlapping Pain Conditions (R01, R21) PA , PA Outline NCCIH Mission & Strategic Plan Funding Opportunities for Investigators Complementary Health Approaches Utilization in the US NCCIH Clinical Research Policies to Enhance Rigor and Reproducibility Framework for Developing & Testing Interventions Clinical Research Oversight Natural Product Integrity Clinical Research Toolkit and Resources 13-yr Trends in Mind and Body Practices in the US 4

5 Selected Mind and Body Practices in % of US Adults Yoga Spinal Manipulation Meditation Massage Therapy Accupuncture Clark et al., (2015), National Health Statistics Reports #79 Most Use Complementary Health Approaches to Manage Pain Outline NCCIH Mission & Strategic Plan Funding Opportunities for Investigators Complementary Health Approaches Utilization in the US NCCIH Clinical Research Policies to Enhance Rigor and Reproducibility Framework for Developing & Testing Interventions Clinical Research Oversight Natural Product Integrity Clinical Research Toolkit and Resources 5

gov/grants/mindbody/framework https://nccih.nih.

6 Framework for Developing and Testing Mind and Body Interventions NCCIH Clinical Research Oversight 6

7 NCCIH Clinical Terms of Award NCCIH reviews and approves study documents before participant recruitment IRB-approval must be submitted to NCCIH Changes to the study that are not administrative in nature require approval by NCCIH before implementation NIH NOT Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval: Updated Notice NCCIH Clinical Terms of Award On-Site Monitoring NCCIH provides independent auditing for many research studies involving human subjects Program assists NCCIH and grantees to ensure participant safety and investigator adherence to applicable regulations Verifies data quality, completeness, and accuracy Regular monitoring of accrual and assessment of study feasibility is essential for the ethical conduct of human subjects research and the proper stewardship of public funds FDA Requirements IND/ IDE Research studies must be done in accordance with FDA guidelines when applicable If an exception is granted by the FDA, it must be granted in writing The awardee/grantee must notify the NCCAM program officer within 3 business days if the FDA places the study on clinical hold 7

8 NCCIH Product Integrity Process Dietary supplements represent a $25 billion industry NCCIH is committed to supporting research into the safety and efficacy of natural products Botanical products have some well-documented quality concerns Implemented a Product Integrity Policy to ensure products used in NCCIH funded studies are well characterized There is no one method for botanical characterization Investigators must develop quality control protocols prior to funding Works closely with FDA to coordinate policies Product Spectrum Complex Proper taxonomy Manufacturing details Fingerprint analysis Refined Focus on chemical characterization Require independent analysis Intended Use Spectrum In vitro animal human Proper taxonomy Fingerprint analysis Supplier Reserve samples + Stability Manufacturing + Reproducibility Formulation IND? Statement from supplier Harvest details Voucher specimen Bioavailability 8

9 Outline NCCIH Mission & Strategic Plan Funding Opportunities for Investigators Complementary Health Approaches Utilization in the US NCCIH Clinical Research Policies to Enhance Rigor and Reproducibility Framework for Developing & Testing Interventions Clinical Research Oversight Natural Product Integrity Clinical Research Toolkit and Resources What is available in the Toolkit Protocol Templates Case Report Forms Informed Consent Template Informed Consent Checklist DSMP Template Description of the On-Site Monitoring Program Links to NIH Policies and Guidance Essential Components of a Regulatory Binder Pharmacy Forms Resources for GCP training Accrual Resources 9

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11 Conclusions Many efforts at NIH to improve quality of clinical research NCCIH recommends utilizing the Conceptual Framework for staging non-pharmacological intervention research Contact NCCIH Program Directors to discuss your research concept Questions? nccih.nih.gov 11

NCCIH s New Approach to Funding Clinical Trials Informational Webinar. April 18, 2017

NCCIH s New Approach to Funding Clinical Trials Informational Webinar April 18, 2017 Introductions Wendy Weber, N.D., Ph.D., M.P.H., Branch Chief, Clinical Research in Complementary and Integrative Health