Surrogate endpoints could be beneficial to dietary supplement industry

WASHINGTON The use of surrogate endpoints to help measure efficacy in clinical trials would be of benefit to the dietary supplement industry, Andrew Shao, SVP scientific and regulatory affairs for the Council for Responsible Nutrition, testified before the Institute of Medicine of the National Academies Monday during a discussion forum around the use of biomarkers and surrogate endpoints in clinical trials.

"The lack of validated biomarkers for exposure to nutrition interventions and as surrogate endpoints for chronic disease limits the amount of research that can be conducted, especially using prospective randomized, controlled intervention trials, due to cost and logistical issues,” Shao said. “This, in turn, limits the ability to derive answers to important questions relating to the ability of diet, food and food components to promote health and reduce the risk of chronic disease.”

And that translates into fewer actionable health claims that either patients or their healthcare professionals can reference when constructing a disease-state-preventative wellness diet.

“We anticipate that a formal biomarker evaluation process will add clarity to product development,” Shao told the panel consisting of members of IOM’s Food and Nutrition Board, Board on Health Care Services and Board on Health Sciences Policy.

Surrogate endpoints are used in place of clinical endpoints in the evaluation of a health benefit  — whether it’s used to establish that benefit for new allopathic medicines or the use of dietary supplements — in large part because of the number of years and/or the large patient population necessary to establish that benefit, such as establishing a clinically evaluated benefit against hip fracture rates, for example.

“Therefore, to replace such a clinical endpoint by another that could be measured earlier, more conveniently or more frequently  — and that would adequately reflect the benefit of new treatments on the true endpoint  — seems an attractive alternative,” wrote Tomasz Burzykowski, senior statistician MSource, in a paper explaining the terminology.