WORLD LEADERS IN DISTINGUISHING PLACEBO FROM ACTIVE IN MEDICAL FOODS AND LIVE THERAPEUTICS
Clinical Trial Design: Cognitive and Mental Health Best Practices
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Duration: 10 min
Abstract: Join Suszie Tyree, Research Manager PhD at Atlantia Clinical Trials, our Research manager who assists in the development of clinical trial protocols studying probiotics, nutraceuticals and medical foods speaks through the main clinical considerations. Gain valuable insight into the clinical trial design for trials investigating the gut-brain axis, including cognitive assessment tools, trial duration, considerations for making regulatory claims, and other aspects of clinical trial design to consider while developing your studies.
Clinical trial design is an important aspect of interventional trials that serves to construct a study that would be able to derive a valid and meaningful scientific conclusion. The basic concept of experimental study design is to study the effect of an intervention, but there are many aspects of clinical trial research where careful thought is required to ensure the success of your clinical trial. While defining your study population, it is important to select the population that is the best representative of the people for whom the treatment is intended. If a product is intended to be used by a healthy population, the clinical trials assessing its efficacy should be performed using healthy participants. Selecting appropriate assessment tools for your research project is also a key area of protocol development, it is important to understand whether the selected assessment tool is likely to capture real change if it occurs. This issue relates to the properties of sensitivity and responsiveness. Sensitivity is an indicator of the instrument’s ability to detect a change in a population beyond measurement error, whereas, responsiveness provides an indicator of the degree of change on a measure that represents real-world, meaningful difference. Knowing details about the sensitivity and responsiveness of your selected assessment tools can also feed into selecting an appropriate duration of your clinical trial. While these details can seem like easy decisions, they should be made with care, as defining the wrong study population or selecting inappropriate tools could have a significant impact on the outcomes of your study, and the outcomes of regulatory claims.
SUSZIE TYREE | Scientific Officer at Atlantia Clinical Trials
Suszie Tyree is a Medical Writer for Atlantia Clinical Trials with a background in scientific research. Suszie received her Master’s degree from Otago University (New Zealand) studying the role of high-fat diet and dietary hormones on brain functions related to anxiety. Following that, Suszie gained her PhD from the University of Potsdam (Germany) in collaboration with the German Institute of Human Nutrition studying food choice behaviours and neural processing of taste information. Prior to joining the team at Atlantia, Suszie also spent three years as a Postdoctoral Research Fellow at Stanford University (California, USA). At Atlantia Suszie develops research protocols and ethics application documents for clinical trials testing food and microbiome-based products on a range of health measures including cognition, microbiome analysis, glucose-response, bone-health, etc. Suszie is also involved in developing clinical study reports to present findings from the studies carried out at Atlantia.