In a statement from the CRN, its VP of scientific and regulatory affairs, Douglas MacKay, ND, emphasized the importance of NCCAM increasing support for basic science and mechanistic studies of dietary supplements to “better inform the design of clinical efficacy studies”.
“Large clinical efficacy studies are extremely expensive and should not be initiated without insight to biological effect and the potential to measure biological effect via biomarkers, or surrogate markers relevant to the hypothesis,” said Dr MacKay.
“To the extent that resources allow, NCCAM should explore supporting the identification and validation of biomarkers and surrogate end points of disease.
“In the absence of validated biomarkers as surrogates for disease, study outcomes must assess the disease endpoints directly, rendering assessment of the effects of CAM therapies on disease risk extremely lengthy and costly,” said MacKay.
“Having the ability to rely on surrogate endpoints dramatically improves the feasibility of human trials, both in terms of duration and total cost,” he added.
Commenting on NCCAM’s Draft Strategic Plan, which can be found here, MacKay said the CRN is “supportive of the proposal to apply greater focus and research priority setting in specific areas where dietary supplements show promise in addressing important public health needs”.
“The NCCAM draft strategic plan cites that limited information exists regarding the safety profile for CAM natural products, including data about interactions with prescription drugs,” said MacKay. “The current evidence base that is used to inform consumers and health care practitioners about supplement-drug interactions and drug induced nutrient depletions is alarmingly deficient.
“CRN encourages NCCAM to support research in this area to help identify clinically relevant interactions and discourage the current practice of using assumed pharmacological theory, incomplete case studies, and other unreliable information as evidence of a supplement-drug interaction.
“NCCAM may also consider supporting systematic analysis of the current evidence base for potential interactions pertaining to dietary supplements and drugs with high use,” he said.
MacKay added that the Council advocates a health lifestyle, involving health diet, exercise, stress managements, and the responsible use of dietary supplements.
“Clinical studies that attempt to isolate one aspect of healthy behavior overlook the potential combined effect of healthy behaviors,” he said. “CRN is pleased to see NCCAM’s recognition of the complexity of studying CAM in real-world settings and supports efforts to develop better tools to investigate multi-component interventions’ influence on patient outcomes.”
The NCCAM draft strategy is open to comments through September 30, 2010.