National Health Science Foundation Accredited Independent Mark of Efficacy (AIME TM ) Session 2
“Many stakeholders believe in the need to provide an independent review of products to accredit those which have robust specific evidence to support them” RATIONALE FOR RECOGNITION OF CLINICALLY PROVEN PRODUCTS
Options for Consumer Information Source Development by the NHSF Recommended
What is the AIME Service? It is an independent way of providing consumers with the ability to • understand whether the clinical claims made for product they are buying has been supported by clinical evidence It provides both an on-pack logo and an online support mechanism • There is a limited database of information about the product (containing • basic product summary information, but not an extensive database) Application for inclusion is made by the company marketing the product • (and in some cases by the ingredient manufacturer)and is controlled through a strict system linked through bar coding) The review of the application by an independent panel (the Clinical • Advisory Board – which is distinct from the Clinical Round Table) The service will be revenue neutral or revenue positive for the NHSF • Both the NHSF and member companies will commit to the promotion of • the Service to ensure it becomes recognised as a mark of product excellence The Panel will also be able to offer advice to companies with an interest • in improving the quality of the their clinical trials with a view to improved chance of publication in preferred journals
Rationale The clear identification of the point of • differentiation of the well developed products in the industry will provide a clear rationale for being a part of the organisation It will start to focus consumer awareness on • Initial the standard they should be seeking Recommendation It will be self funding and provide funds to • promote both the service and the organisation in its formative years It provides a visible means of highlighting • product excellence and is a critical means of raising the bar for all players The detailed database solutions, either • alone or with the ABC continue to be important but given the limited resources of the organisation the early efforts need to focus on the activities that will provide the widest interest. The next stage of database development • should be considered at approximately Year 3-4of the organisations operational life
The Assessed Independent Mark of Efficacy HOW DOES IT WORK
What does the AIME Service Do and How does it Work On Pack “Tick” Administered by the NHSF • Secretariat Denoting Levels of Evidence All product inclusion • Facility to accommodate high recommendations are Quality Ingredient Sources completely at the discretion of Equivalent Products ? TBC the Independent Advisory Board The Advisory board is made up of • Global experts in the Clinical Trials Review Services development and assessment of Pre-Trial review service to assist clinical evidence companies to ensure that their trial design is robust and will Costs associated with the • provide a meaning answer to the question they are posing, and Advisory Committee are covered will meet the standard of well by the assessment fees recognised peer reviewed journals The NHSF and Member • Post trial review of results Companies commit to the promotion of the “Tick” and the Clinical Trials Advisory service
Clinical Advisory Board The Clinical Advisory Board (CAB)is a group of 6 independent • experts with global recognition in their area of specialty and with a proven track record in successful clinical trial development and assessment, a strong list of publications, and editorial experience on a range of peer reviewed clinical journals The role of the CAB is: • – To determine the criteria for product inclusion in the AIME – Review all applications for product inclusion into the AIME and approve / reject and assign status – Sign off on final documentation posted on the AIME – CAB Chair to advise the CEO of key issues, opportunities for improvement and concerns pertaining to the AIME; and to provide advice to the Board as required – The CAB Chair is not a member of the Board of Directors
Proposed CAB Membership Chair Professor John Funder AC MD BS PhD FRACP FRCP LLD (Hon Monash University), • DMedSci (Hon University of Melbourne), MD (Hon. University of Sydney) Chair of NICM Advisory Board; Member of NICM Research Committee – John Funder was President of the Australian Society for Medical Research (1979)and the – Endocrine Society of Australia (1984), and (1996 – 2000) Chairman of the International Society for Endocrinology. In 1990 he resigned as a Senior Research Fellow of the National Health and Medical Research Council to become Director of the Baker Medical Research Institute (1990 – 2001). He is a Senior Fellow at Prince Henry's Institute of Medical Research at Monash Medical Centre, and a Professorial Fellow at the Centre for Neuroscience at the University of Melbourne. Having published over 500 scientific papers, Funder is an expert in mineralocorticoid receptors and aldosterone biology and serves as a consultant to many pharmaceutical companies engaged in this field. Dr. Gerry Bodeker researches and advises on international public policy on traditional • (indigenous), complementary & alternative medicine and wellness. Having completed Doctoral studies at Harvard, he has held research and teaching – appointments in the Division of Medical Sciences at Oxford University for two decades. Dr. Bodeker has been chair of the Commonwealth Working Group on Traditional & Complementary Medicine and done work on medicinal plant conservation for the World Bank, the Global Environment Facility, UNU, and the UN Food & Agriculture Organization. He is co-founder of the WHO-affiliated Research Initiative on Traditional Antimalarial Methods (RITAM). He has written extensively on traditional medicine and is editor-in-chief of the WHO Global Atlas on Traditional and Complementary Medicine and serves on the editorial boards of several journals. He has authored chapters in the Encyclopedia of Public Health (Elsevier 2008, 2017) on "The health of indigenous peoples" and on "Integrative medicine".. He is a Fellow of the International Union of Pure & Applied Chemistry
Proposed CAB Membership - Continued Sir Peter David Gluckman, ONZ, KNZM, FRS, FMedSci, FRSNZ is a New Zealand • paediatrician. He is currently the inaugural Chief Science Advisor to the New Zealand Prime Minister. Associate Professor David Eisenberg - Associate Professor of Nutrition at Harvard T.H. Chan • School of Public Health and Executive Vice President for Health Research and Education at the Samueli Institute.. From 2000-2010, Eisenberg served as the founding Director of the Osher Research Center at Harvard Medical School and the founding Chief of the Division for Research and Education in Complementary and Integrative Medical Therapies. He simultaneously served as the Director of the Program in Integrative Medicine at the Brigham & Women’s Hospital. His current educational and research interests include: (1) studies to assess the safety, clinical, and cost effectiveness of complementary and integrative medical therapies; (2) the systematic evaluation of herbal medicines using state of the science technologies; and (3) novel multi-disciplinary strategies to optimize lifestyle and self-care behaviors (e.g., diet, exercise and stress management) to prevent, treat and manage common medical conditions. Eisenberg is a graduate of Harvard College and Harvard Medical School. He completed his fellowship training in general internal medicine and primary care and is Board Certified in Internal Medicine. Eisenberg has served as an advisor to the National Institutes of Health, the Food and Drug Administration, and the Federation of State Medical Boards with regard to complementary, alternative and integrative medicine research, education, and policy.
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