• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Exclusives
    • Nutraceuticals
    • Markets
    • Health
    • Jobs
    • Events
    • Buyers' Guide
    • Showcases
    • More
  • Magazine
  • News
  • Exclusives
  • Nutraceuticals
  • Markets
  • Health
  • Jobs
  • Events
  • Buyers' Guide
  • Showcases
  • Current & Past Issues
    Features
    Columns
    Editorials
    Digital Edition
    Subscribe Now
    Advertise Now
    eNewsletter
    Editorial Guidelines
    Top Features
    Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains

    Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality

    Nutrition and Flavor: Formulating for Modern Product Preferences

    What Do Consumers Know About the Gut Microbiome?

    How Will the European Green Deal Impact Dietary Supplements?
    Breaking News
    Certifications, Approvals and Patents
    Exclusives
    Industry & Market News
    People
    Products
    Regulatory
    Research
    Supplier News
    Supplier Insights
    Live From Shows
    Top News
    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion

    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy

    Lauren Aronson Joins Amin Talati Wasserman, LLP

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Exclusives
    Blogs & Guest Articles
    Health E-Insights
    Area Code 420
    eBook
    Antioxidants
    Dairy-Based Ingredients
    Enzymes
    Fatty Acids
    Fiber & Carbohydrates
    Green Foods
    Herbs & Botanicals
    Marine Nutraceuticals
    Minerals
    Omega 3s
    Probiotics & Prebiotics
    Proteins, Peptides, Amino Acids
    Sweeteners
    Vitamins

    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion

    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression
    Consumer Trends
    Contract Manufacturing
    Cosmeceuticals / Nutricosmetics
    Delivery & Dosage Technologies
    Dietary Supplements
    Flavors & Colors
    Functional Foods & Beverages
    Healthcare Trends
    Medical Nutrition
    Mergers & Acquisitions
    Natural/Organic
    Nutrition Bars
    Packaging
    Pet Nutraceuticals
    Quality & Safety
    Regulations
    Research
    Testing
    World Markets

    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion

    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy

    Lauren Aronson Joins Amin Talati Wasserman, LLP

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Bone & Joint Health
    Cancer Risk
    Cardiovascular Health
    Cognitive Function
    Diabetes & Blood Sugar Management
    Digestive Health
    Energy
    Eye Health
    Healthy Aging
    Immune Function
    Infant & Children's Health
    Inflammation
    Men's Health
    Mood Health & Sleep
    Oral Health
    Sexual & Reproductive Health
    Skin Health
    Sports Nutrition
    Weight Management/Weight Loss
    Women's Health

    Vitamin K2 May Ameliorate Polycystic Ovary Syndrome

    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

    Omega-3 Fatty Acids Linked to Reduced Episodes of Depression

    Charlotte’s Web Sports Product Line to Undergo NSF Certification Process

    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    Industry Events
    Live From Show Events
    Webinars
    All Companies
    Categories
    Trade Associations
    Company Capabilities
    International Buyers Guide Companies
    KLK OLEO

    BGG World

    Verdure Sciences

    Sabinsa Corporation

    Xsto Solutions
    Companies
    Product Releases
    News Releases
    Literature / Brochures
    White Papers
    Jobs
    VIdeos
    Services
    Add New Company
    International Buyers Guide Companies
    KLK OLEO

    BGG World

    Verdure Sciences

    Sabinsa Corporation

    Xsto Solutions
    • Magazine
      • Current / Back Issue
      • Features
      • Editorial
      • Columns
      • Digital Edition
      • eNewsletter Archive
      • Editorial Guidelines
      • Subscribe Now
      • Advertise Now
    • Breaking News
    • Buyers' Guide
      • All Companies
      • Categories
      • Trade Associations
      • Company Capabilities
    • Nutraceuticals
      • Antioxidants
      • Dairy-Based Ingredients
      • Enzymes
      • Fatty Acids
      • Fiber & Carbohydrates
      • Green Foods
      • Herbs & Botanicals
      • Marine Nutraceuticals
      • Minerals
      • Omega 3s
      • Probiotics & Prebiotics
      • Proteins, Peptides, Amino Acids
      • Sweeteners
      • Vitamins
    • Markets
      • Consumer Trends
      • Contract Manufacturing
      • Cosmeceuticals / Nutricosmetics
      • Delivery & Dosage Technologies
      • Dietary Supplements
      • Flavors & Colors
      • Functional Foods & Beverages
      • Healthcare Trends
      • Medical Nutrition
      • Mergers & Acquisitions
      • Natural/Organic
      • Nutrition Bars
      • Packaging
      • Pet Nutraceuticals
      • Quality & Safety
      • Regulations
      • Research
      • Testing
      • World Markets
    • Health
      • Bone & Joint Health
      • Cancer Risk
      • Cardiovascular Health
      • Cognitive Function
      • Diabetes & Blood Sugar Management
      • Digestive Health
      • Energy
      • Eye Health
      • Healthy Aging
      • Immune Function
      • Infant & Children's Health
      • Inflammation
      • Men's Health
      • Mood Health & Sleep
      • Oral Health
      • Sexual & Reproductive Health
      • Skin Health
      • Sports Nutrition
      • Weight Management/Weight Loss
      • Women's Health
    • Online Exclusives
    • Webinars
    • Slideshows
    • Blogs & Guest Articles
    • Health E-Insights
    • Videos
    • Podcasts
    • Infographics
    • eBook
    • Whitepapers
    • Research
      • TrendSense
      • Monograph Center
      • White Papers
      • Research News
    • Jobs
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Supplier Showcases
      • Companies
      • Product Releases
      • News Releases
      • Literature / Brochures
      • White Papers
      • Jobs
      • VIdeos
      • Services
    • About Us
      • About Us
      • Contact Us
      • Advertise With Us
      • Privacy Policy
      • Terms of Use
    Features

    Dietary Supplement Clinical Research in the Age of COVID-19: Challenges & Opportunities

    The fundamental importance of ensuring studies are well-designed has been magnified by challenges brought about by COVID-19.

    Dietary Supplement Clinical Research in the Age of COVID-19: Challenges & Opportunities
    Related CONTENT
    • Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    • Fact or Myth: Antioxidants Negatively Impact Iron Absorption
    • IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    • Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    • People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds
    07.23.20
    By Annahita Ghassemi, PhD, Director, Global Product Safety & Clinical Affairs, Church & Dwight Co. Inc., (and Chair of CRN’s Senior Scientific Advisory Council) & Luke Huber, ND, MBA, Vice President, Scientific & Regulatory Affairs, Council for Responsible Nutrition (CRN)

    Research will continue to play a key role in developing innovative ingredients and finished products, as top research organizations adapt to the changes required by COVID-19—underscoring the importance of a culture of agility with rapid implementation of new processes.
     
    A CRN-convened webinar included insights from the following experts who discussed their experiences conducting clinical trials in the midst of the pandemic: John Marshall, MBA, general manager, Biofortis Clinical and Sensory Research; Andrew Gregg, director, Clinical Research, dicentra; Joshua Baisley, vice president, Clinical Design & Delivery, Nutrasource Pharmaceutical & Nutraceutical Services; and Catherine Kwik-Uribe, PhD, Global Scientific & Regulatory Affairs director, Mars Edge.
     
    In the U.S., the Food and Drug Administration (FDA) addresses challenges with conducting research while under a shelter-in-place order in its guidance for industry sponsors, investigators, and institutional review boards (IRBs)—a document that research administrators should familiarize themselves with, especially with a resurgence of COVID-19 predicted, Marshall advised.
     
    Marshall described one of Biofortis’ multi-site study’s shift to a mix of three different scenarios: one site shut down completely; another site stayed open and conducted the visits with little interruption; and the third site modified visits to capture only primary endpoints. “There were unavoidable protocol deviations,” he observed. FDA recognizes that changes to protocols are inevitable in these times and emphasizes that these modifications should be well documented.
     
    Sponsors, investigators, and IRBs should make every effort to maintain the safety of trial participants and study integrity. Clear documentation is indispensable to ensuring all parties are aligned, Marshall counseled. For example, Biofortis implemented enhanced preparation procedures, checking in with participants the day prior to their site visit and clearly communicating the new measures in place to keep them safe, including outdoor check-in prior to entry into the building, required facial coverings, and use of hand sanitizer and gloves. In addition, tightened controls over participant movement in the facility, with staff rotating through the trial visit one at a time, allows for better participant traceability and a complete wipe-down of the areas occupied by participants—all noted in updates to protocol documentation.
     
    Enhanced communication among staff as well as with trial participants and sponsors is another key factor driving success, Marshall observed. He noted that while this can require technology and training investments, these costs are often offset by the savings from fewer in-clinic visits. “The effort Biofortis put into adjusting operations and communicating with trial candidates has paid off,” he stated. “We've actually seen an increase in study participant interest.”
     
    Gregg echoed Marshall’s comments regarding the ease with which his firm, dicentra, is retaining study participants even during the pandemic. He noted Canada’s regulatory body Health Canada emerged following the last comparable pandemic, The Spanish Flu of 1918, with further regulatory reform for dietary supplement research—an expedited pathway—arising from the COVID-19 pandemic. He noted Canada’s regulatory framework for the clinical research of dietary supplements (Natural Health Products, or NHPs) encompasses the International Conference on Harmonisation (IHC) Good Clinical Practice (GCP) Guidelines. These global quality standards, while the primary foundation of the clinical research industry, are meant to complement additional inputs, Gregg advised. “Now more than ever it's important to remember that GCP guidelines include not only the ICH guidelines themselves but local regulation and law as well as best practices.” These include safety management and exposure reduction efforts in accordance with local and global guidelines, and enhanced, protocol-specific participant safety considerations.
     
    Industry sponsors are looking to re-establish research operations as soon as possible—many in Q3 and Q4 2020 after project re-evaluation and site re-selection, Gregg noted. He advised that global disruption of trials slated to begin in Europe and the U.S. has led to considerable site re-selection by industry sponsors. “Canadian sites accommodated many of these projects due to a lesser degree of industry disruption compared to other jurisdictions,” he stated.
     
    Baisley, whose firm, Nutrasource Pharmaceutical & Nutraceutical Services, also headquartered in Canada, provided a global perspective on how regulatory guidance unfolded as COVID-19 spread in early 2019. Similarities across most global regulatory guidance include prioritization of subject safety, which should always be the case in any clinical trial, Baisley noted. Minimizing the risk to data integrity and maintaining compliance with GCPs are also common goals among the guidances. “They're looking to ensure sponsors and [contract research organizations (CROs)] are conducting risk assessments on the programs that they’re either currently undertaking or looking to undertake,” he explained. Other key similarities include calls for thorough documentation of protocol deviations. Similarities notwithstanding, he noted the importance of maintaining awareness of updates to guidances, especially when conducting multicenter, multi-jurisdictional trials, observing significant differences among various EU countries.
     
    The panelists emphasized that preparing for the possibility of ongoing shutdowns and resurgence of the virus is critical. Agencies around the world are expecting this, they agreed, and contract reviews—who's responsible for what—and additions of contingency plans are must-dos. “We should be looking for business continuity plans and seeing what processes and contingencies are in place if this comes up again with wave two or three,” Baisley advised.
    The panelists acknowledged that delays will likely result in extended overall program timelines that can also delay measurements if there are differences among analytical labs. Further, they noted the importance of amending outpatient assessments, optimizing remote reporting procedures and following up on adverse events—especially those related to COVID-19.
     
    Some sponsors are finding new opportunities in studies already underway, such as with the COSMOS trial examining multivitamin and cocoa flavanol effects on various health endpoints. Kwik-Uribe discussed how Mars Edge has proactively added to its data collection based on the impact of COVID-19 among its 22,000 participants. “Because of the fact that there's such comprehensive data being collected on the study participants, we do expect that if there is an impact on COVID-19 or anything related to the study outcomes we'll be able to capture this information, as well,” she noted. COSMOS will now also explore how risk factors and a subject’s diet and lifestyle habits play into susceptibility and severity of outcomes. The researchers are leveraging the biospecimen collection to learn more about the mechanism of action of SARS CoV-2, the virus that causes COVID-19.
     
    The fundamental importance of ensuring studies are well-designed has been magnified by challenges brought about by COVID-19. The pandemic has also shown that attentive, engaged, and communicative partnerships among research organizations and their sponsors is critical.
     
    Hear more from these expert panelists via CRN’s webinar on demand. Get details here:www.crnusa.org/CRO.  
     
     
     
    Related Searches
    • Dietary Supplements
    • Quality & Safety
    • Healthcare Trends
    • Research
    Related Knowledge Center
    • Research
    • Dietary Supplements
    • Regulations
    Suggested For You
    Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    Fact or Myth: Antioxidants Negatively Impact Iron Absorption Fact or Myth: Antioxidants Negatively Impact Iron Absorption
    IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations
    Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits
    People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds
    Chenland Nutritionals Self-Affirms GRAS for Cumin UP60 Ingredient Chenland Nutritionals Self-Affirms GRAS for Cumin UP60 Ingredient
    Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds Flower Pollen Extract Benefits Women’s Urinary Incontinence, Study Finds
    Vital Nutrients Launches First Vegan Omega Supplement with SPMs Vital Nutrients Launches First Vegan Omega Supplement with SPMs
    Earth Mama Organics Achieves Earth Mama Organics Achieves 'Plastic Neutral' Certification
    TopGum Gummies Receives USDA Organic Certification TopGum Gummies Receives USDA Organic Certification
    VITAL Ancillary Study Finds No Link Between Vitamin D and Bone Fracture Risk VITAL Ancillary Study Finds No Link Between Vitamin D and Bone Fracture Risk
    What People Were Reading in July 2022 on NutraceuticalsWorld.com What People Were Reading in July 2022 on NutraceuticalsWorld.com
    JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients JAMA: FDA Warning Letters Fail to Result In Removal of Illegal Supplement Ingredients
    FDA Issues Final Guidance on NAC Supplements FDA Issues Final Guidance on NAC Supplements
    Krill Oil Study Provides Evidence of Osteoarthritis Benefits Krill Oil Study Provides Evidence of Osteoarthritis Benefits

    Related Breaking News

    • Breaking News | Medical Nutrition | Research | Research News | Sports Nutrition | Vitamins
      Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

      Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise

      A small trial on overweight women with non-alcoholic fatty liver disease found that a daily dose of vitamin D offered hepatoprotective benefits.
      08.15.22

    • Antioxidants | Delivery & Dosage Technologies | Herbs & Botanicals | Minerals | Research
      Fact or Myth: Antioxidants Negatively Impact Iron Absorption

      Fact or Myth: Antioxidants Negatively Impact Iron Absorption

      Recent studies show curcumin administered in the bioavailable form HydroCurc® does not harm iron absorption or iron stores.

    • Consumer Trends | Vitamins | World Markets
      IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations

      IADSA Calls for Addressing Discrepancies in Vitamin C Recommendations

      Aligning guidance can help ensure that people around the globe are receiving the optimal dose, the organization reported.
      08.10.22


    • Breaking News | Cognitive Function | Dietary Supplements | Energy | Herbs & Botanicals | Research | Supplier News
      Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits

      Caffeine-Free Energy Supplement Linked to Alertness, Fatigue Benefits

      OmniActive Heatlh Technologies’ EnXtra improved subjects’ performances in a five-hour assessment.
      08.10.22

    • Dietary Supplements | Digestive Health | Probiotics & Prebiotics | Research
      People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds

      People with Low-Fiber Diets Benefit the Most from Fiber Supplements, Study Finds

      Three different types of fiber all resulted in butyrate production in a group of 28 participants that was based on baseline fiber intake.
      08.09.22

    Loading, Please Wait..
    Trending
    • Study Examines Vitamin K2 Content In Cheese
    • Chenland Nutritionals Self-Affirms GRAS For Cumin UP60 Ingredient
    • Omega-3 Fatty Acids Linked To Reduced Episodes Of Depression
    • Pycnogenol Evidenced To Have Skin Benefits In Dermatology Study
    • ADM And Benson Hill Partner To Scale High Protein Soy For U.S. Market
    Breaking News
    • Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion
    • BASF Venture Capital and Aqua-Spark invest in Sea6 Energy
    • Lauren Aronson Joins Amin Talati Wasserman, LLP
    • Vitamin K2 May Ameliorate Polycystic Ovary Syndrome
    • Vitamin D May Prevent Changes to Liver Enzymes and Lipid Profile After Exhaustive Exercise
    View Breaking News >
    CURRENT ISSUE

    July/August 2022

    • A Growing Herbal Products Market Still Faces Formidable Threats, Challenges
    • Analytical Testing in Nutraceuticals: Methods and Mindsets to Uphold Quality
    • Nutrition and Flavor: Formulating for Modern Product Preferences
    • Contract Manufacturing: Trials & Tribulations of Today’s Supply Chains
    • How Will the European Green Deal Impact Dietary Supplements?
    • What Do Consumers Know About the Gut Microbiome?
    • View More >

    Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
    You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

    • About Us
    • Privacy Policy
    • Terms And Conditions
    • Contact Us

    follow us

    Subscribe
    Nutraceuticals World

    Latest Breaking News From Nutraceuticals World

    Herbalist and Alchemist Celebrates 40th Anniversary, Announces Expansion
    BASF Venture Capital and Aqua-Spark invest in Sea6 Energy
    Lauren Aronson Joins Amin Talati Wasserman, LLP
    Coatings World

    Latest Breaking News From Coatings World

    Ashland Completes Sale of Land in Ajax, Canada
    Chemours Begins Commissioning New Sand Mine in Clay County, FL
    Evonik Increases Production Capacities for ACEMATT Matting Agents
    Medical Product Outsourcing

    Latest Breaking News From Medical Product Outsourcing

    M1 MedTech Announces Fall 2022 Cohort
    Preceptis Medical’s Tympanostomy Tube System Cleared for Expanded Indications
    Dyad Medical’s Echocardiogram Application Cleared by FDA
    Contract Pharma

    Latest Breaking News From Contract Pharma

    Grand River Aseptic Manufacturing Completes Phase II Expansion
    WCG Appoints Rahul Bafna Chief Product Officer
    WuXi STA Breaks Ground for New Pharma Mfg. Campus in Middletown, DE
    Beauty Packaging

    Latest Breaking News From Beauty Packaging

    SOS Beauty Fills Several Senior Leadership Positions
    Beauty Sales to Higher Income Consumers in U.S. Increase Double-Digits in 2022
    Johnson & Johnson to Discontinue Global Sales of Talc-Based Baby Powder
    Happi

    Latest Breaking News From Happi

    Net Sales Down 5% in Second Quarter Results for Bath & Body Works
    Legacy Skincare Brand Albolene Launches New Line of Facial Cleansers
    Arm & Hammer Laundry Continues Partnership with Dress for Success as Presenting Sponsor of 2022 Virtual Power Walk
    Ink World

    Latest Breaking News From Ink World

    DuPont Selects 2022 Lavoisier and Pedersen Award Medalists
    Chemours Begins Commissioning Newest Sand Mine in Clay County, FL
    Marabu to Present Safe Inks for Indirect Contact with Food at K 2022
    Label & Narrow Web

    Latest Breaking News From Label & Narrow Web

    ePac Flexible Packaging announces global expansion
    Tharstern offering free 3-month trial of new Tharstern Cloud at Labelexpo
    Simco-Ion Industrial expands application engineering expertise
    Nonwovens Industry

    Latest Breaking News From Nonwovens Industry

    Because Market Expands into Retail Stores
    Tranzonic Acquired by Private Investment Firm
    Monadnock Earns EcoVadis Gold Rating
    Orthopedic Design & Technology

    Latest Breaking News From Orthopedic Design & Technology

    FDA OKs VySpine's VyPlate Anterior Cervical Plates
    Moximed Raises $40M for Knee OA Shock Absorber Implant
    Exactech Rolls Out Spartan Stem and Logical Cup
    Printed Electronics Now

    Latest Breaking News From Printed Electronics Now

    DuPont Names 2022 Lavoisier and Pedersen Award Medalists
    Photonic Glasses Give Solar Panels Pleasing Colors
    SEMI Appoints John Cooney to Lead Global Advocacy and Public Policy

    Copyright © 2022 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

    AD BLOCKER DETECTED

    Our website is made possible by displaying online advertisements to our visitors.
    Please consider supporting us by disabling your ad blocker.


    FREE SUBSCRIPTION Already a subscriber? Login