Commenting on NCCAM’s latest five-year strategic plan, Dr Douglas MacKay, CRN’s vice president science and regulatory affairs, told NutraIngredients-USA.com: “We support NCCAM’s allocation of resources to help the development and validation of biomarkers as modifiable surrogate endpoints for both disease and ‘wellness’.”
Intervention studies
Implementing clinical trials using surrogate endpoints, such as omega-3 cell membrane levels, inflammatory cytokine profiles, and macular pigment density, could boost global complementary and alternative medicine (CAM) by providing the foundation for shorter and more cost effective intervention studies, he added.
Dr MacKay said the lack of validated biomarkers meant that regulators don’t regard them as sufficient information on which to base a regulatory decision. But clinical trials conducted using the development of chronic diseases as clinical endpoints are both costly and complex.
Meanwhile, CAM interventions such as the consumption of adequate omega-3 fats, vitamin D and lutein/zeaxanthin, can cut the incidence of chronic diseases such as cardiovascular disease, cancer, and macular degeneration, said Dr MacKay.
He also highlighted NCCAM’s role in persuading regulators and others of the value of multi-system intervention testing methods rather than relying solely on randomized controlled placebo trials.
“NCCAM’s work in exploring other research methodologies as opposed to randomized clinical trials is an important contribution. This involves bringing together (assessments of) diet, life-style, supplementation and stress management,” said Dr MacKay.
In a written response to the strategy document, CRN pointed out that: “NCCAM resources may be better allocated identifying and validating multiple objective measures that are known contributors to general health and wellness, while recognizing that these measures are only small, but measurable pieces to a larger puzzle.
Biomarkers
“General health could be defined as a combination of physical measurements (BMI, percent body fat, basal body temperature, blood pressure, etc.) and biomarkers (inflammatory profile, omega 3 index, serum 25hydroxyvitamin D levels, macular pigment density, bone density, etc.)”.
Finally, Dr MacKay voiced his appreciation for NCCAM’s focus on thorough characterization of test material used in clinical trials, which assists with reproducibility of results. “We applaud initial efforts that NCCAM and the Office of Dietary Supplements (ODS) have taken to address this problem (of formerly poor characterization), and endorse the continued allocation of resources to this area,” he said.