Future Perspectives: What does the mHealth and wearable ‘revolution’ mean for trial design and management?
1:00pm CET (Paris)
The rapid growth of mobile health technologies, apps and wearable devices in recent year provides the clearest evidence of changing times and accelerated innovation in the mHealth space. This session will explore how these new technologies are impacting the design and management of clinical trials.
From the ability to better recruit participants, to how new technologies will drive improvements in measuring health outcomes and increase compliance in trial settings, our expert panellists will discuss the future of digital clinical trials.
Human challenge models for infection resistance as valuable tools to substantiate the beneficial health effects of food ingredients
1:45pm CET (Paris)
Presenter: Alwine Kardinaal
Human clinical trials to support health benefits of food ingredients in the healthy population are generally large-sized studies, requiring substantial investments. There is a large gap between preclinical work, and the generation of evidence in humans. To bridge this gap, the use of human challenge models can reduce the risk of failure in field trials. In these smaller-sized trials, a controlled challenge is provided to healthy subjects, to measure the effect of food ingredients on resilience to the stressor. For infection resistance, we apply an E. coli challenge model (gut infection), a rhinovirus challenge model (upper respiratory tract infection), and a vaccination model (immune function related to infection resistance). The presentation will discuss the design and primary outcomes of these models, illustrated with results from interventions.
Challenge models and data driven experimental design…? How to improve the efficiency of your experimental design?
Presenter: Wynand Alkema
In order to capture the most value from your clinical trial, a large number of secondary or tertiary endpoints can be measured for analysis. With the technological advances in multiplexing and miniaturization techniques, it is now possible to simultaneously measure the levels of thousands of metabolites, proteins and transcripts in human blood as well as the occurrence of hundreds of microorganism at various body sites.
Harvesting, processing and understanding these big data sets, can shed light on the underlying mechanisms of (lack of) efficacy and possible side effects of the intervention. Similarly, such data can be obtained on predictive in-vitro or animal models, which may help to prospectively improve trial design with respect to e.g. subject selection, dose optimisation and biomarker identification.
In this talk we will outline and illustrate such data driven clinical trial approaches.
Making a Claim: Regulatory Considerations
2:30pm CET (Paris)
Clinical trials are an insurance policy for claims purposes. Designing good randomized clinical trials that can prove efficacy for dietary supplements is challenging. For clinicians to be convinced of the value of Dietary Supplements, they need the proof of their safety and efficacy. Study designs should be tailored to answer specific questions about whether the intended claim is broad or specific.
What You Will Learn:
• Research Requirements for Claims Substantiation in North America
• Key elements of Study Design
• Subgroup Analysis
• Statistical Significance vs. Clinical Relevance
• Current changes in regulations to support paradigm changes to support subgroups.
Speakers: Najla Guthrie
Exploring Human Food Clinical Trials
3:15pm CET (Paris)
In highly competitive industries, differentiation is key. The alimentary and nutraceutical sector has faced multiple challenges within the last few years, particularly, in terms of the regulation around the marketing of functional foods and their associated health claims. With the market expecting to reach a value of $ 300,000 million by 2022, overcoming these hurdles is a must for those companies willing to compete for success.
The first step for differentiation is to prove the health benefits potentially associated with functional foods, beverages, probiotics or medical foods. Randomised Controlled Trials (RCT’s) are considered the gold standard method for the scientific substantiation of claims by EFSA & FDA. Join us to unveil the secrets of RCT’s within the nutraceutical industry.