LONDON, ON (October 29, 2019) – A significant shift has taken place in scientific and statistical concepts in the nutraceutical space – a shift that Dr. Mal Evans, Chief Scientific Officer, KGK Science, and her team has been advocating for since 2014. A recent announcement by the American Statistical Association (ASA) and New England Journal of Medicine (NEJM), on the “non-significance of the p value in determining the success of the efficacy of a product” moves away from the model commonly used in pharmaceutical science which Dr. Evans says is a major win for the supplement industry.
“Strong science and biostatistical methodology are fundamental in providing appropriate evidence for claims substantiation and direction to an industry that has long struggled to gain traction under the constraints of the pharmaceutical model,” stated Evans.
For the past 5 years, Dr. Evans has espoused the need for regulators to focus away from p values to more appropriate measures of evaluating the success of supplements in clinical trials. In 2017, Dr. Evans and her team proposed new concepts for study design to augment the traditional randomized controlled trial (RCT) model as well as a global index as a measurement tool better suited to assess the multifaceted nature of supplements. Two years later, KGK Scientists presented at the American Society of Nutrition’s Nutrition 2019 conference how aggregated N-of-1 studies can be used with a global index to assess the effectiveness of probiotics.
Dr. Evans is pleased to see the wave of innovative ideas presented by her team gaining traction in the industry. According to the NEJM, “Journal editors and statistical consultants have become increasingly concerned about the overuse and misinterpretation of significance testing and p values in the medical literature. Along with their strengths, p values are subject to inherent weaknesses, as summarized in recent publications from the American Statistical Association. … Finally, the notion that a treatment is effective for a particular outcome if p < 0.05 and ineffective if that threshold is not reached is a reductionist view of medicine that does not always reflect reality.”
KGK Lead Statistician and former Chief Technology Officer and Pharmacovigilance Consultant at the WHO Collaborating Centre for Advocacy and Training in Pharmacovigilance, Dr. Abdul Malik Sulley commented: “The ASA and NEJM have finally moved in a direction that has been long held at KGK, a direction that involves looking beyond the significance level or its adjustments. The case for challenging the practice of adjusting for multiple outcomes is much stronger in the nutraceutical space, where people often have endogenous levels of nutrients, which often tend to have effects on multiple health outcomes. This results in very small effect sizes that may be clinically significant yet testing each outcome at a fraction of a significance level of 0.05 increases the chance that effective interventions are not discovered.”
KGK Science has been at the forefront of scientific research in the nutraceutical industry for over 20 years; experience that they are now transitioning over into the evolving world of cannabis. “We are encouraged by this new era in the supplement industry,” says KGK President and CEO, Najla Guthrie. “Our esteemed team of scientists and researches continue to be a step ahead of the curve which is a reflection of their experience and dedication to advancing natural health and wellness.”
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About KGK Science Inc.
As a global Contract Research Organization (CRO), KGK Science performs a productive and pioneering role in the realm of scientific study. For over two decades, it has offered well-designed, customized solutions to each of its clients, consolidating its scientific, clinical, commercial, and regulatory abilities into one full-service package. Equipped with state-of-the-art technologies, novel research techniques, and a seasoned team of thought leaders, KGK Science remains at the forefront of its industry. By seamlessly matching its experience with its drive for innovation, this CRO can respond effectively to expanding trade and consumer demands.