NCCAM streamlines quality aspect of funding review
funding approval procedure simplified, thanks to the formation of a
new working group specifically focused on quality.
Steven Dentali, chair of the new PQWG (Product Quality Working Group) and VP for scientific and technical affairs at the American Herbal Products Association explained to NutraIngredients-USA.com that quality information had previously been asked on applications at study section, when research proposals are reviewed.
"It became clear that that product quality issues often required a distinct and sometimes separate focus because researchers rarely got this part of the research proposal right," he said.
In June 2005 the advisory council of the National Center for Complementary and Alternative Medicine (NCCAM) approved the formation of the PQWG, and the group was actually formed this winter for an initial trial cycle.
A guidance document detailing 20 points of information to be provided by botanical researchers can be accessed online. This includes identification of the source material, source, cleanliness and quality standards, extraction procedures and formulation, stability and storage.
Similar guidelines are also available for proposed research into animal-derived products, probiotic, placebos and other agents.
The PQWG will meet three times during the cycle to review the quality information submitted by the highest scoring proposals from the study section before a funding decision is made.
The first meeting has already been held, and Dentali said about 50 percent of the proposals included sufficient quality information. In the remainder of cases, the group requested more details from applicants.
The five-member working group took two hours to review the quality aspects of the proposals, whereas previously it took several days to review all the proposals at study section, high scoring or otherwise.
Last week Dentali reported back to the advisory council on the meeting, and the text of his talk is to be used on the NCCAM website to help researchers understand the new product quality requirements.
In a recent survey it was found that only four percent of applicants have NCCAM training. While they may be very qualified in their field, their field has not previously included natural products.
Dentali said that, in the past, quality problems have come to light after studies have been completed. For example, a study conducted by the University of California at San Francisco and Memorial Sloan-Kettering Cancer Center found that a herbal blend known as PC-SPES reduced a marker for prostate cancer in 50 percent of participants with hormone resistant prostate cancer.
However in 2002 PC-SPES was withdrawn from the market after being found to contain prescription drugs.
"While it may seem burdensome to require preeminent researchers in their chosen field to jump through NCCAM product quality just-in-time hoops, we cannot allow good scientific work to go to waste because the natural product link isn't adequately developed," said Dentali.
"If scientists want NCCAM funds to study natural products, then adequate required expertise must be brought to bear."
