A Market Worth Watching

Without the need for a prescription or medical illness and with a usual intake requirement of every day, dietary supplements would appear to be a prime market for clinical research companies. So, why are dietary supplements supported by the safety and efficacy data of a clinical trial so few?

Najla Guthrie, president and chief executive officer of KGK Synergize.

Without a solid regulatory requirement across regions and without an outcry from consumers for more scientific evidence of products, there has been little pressure for companies to delve into this field. But as the market continues to experience growth, the clinical research community may eventually be singing a different tune.

Regulatory inconsistencies

The regulatory climate varies greatly for dietary supplements and not all agencies require that they be supported by clinical trials. For instance, the United States only requires an IRB approval. Unless, that is, a company wants to make a claim to treat, cure, mitigate or prevent a disease, then the same procedures must be followed as for a chemical drug.

These products in the EU, however, are subject to a scientific opinion of the Committee on Herbal Medicinal Products based on existing scientific data or on historic use of that product in Europe. The EU also has GMPs in place for these products.

"In Canada prior to January 2004 we only had to apply to an IRB and then they brought in the natural health products directorate, requiring companies with products on the market to apply for a product number to be able to make claims and substantiate the safety and efficacy of the product," explained Najla Guthrie, president and chief executive officer of Ontario-based KGK Synergize—a contract research services and product development company.

Also, "if you are conducting a clinical trial on a natural health product, that branch reviews your clinical trial and protocol as well as the safety information, quality, and manufacturing. So it's very similar to the drug side," she added.

Setting yourself apart

While there is no shortage of development, there is a lack of dietary supplements with proven safety and efficacy that ensures consumers are getting what they are expecting.

A survey conducted by KGK Synergize showed pharma spends under one percent on R&D for dietary supplements, while they shell out up to 20% in the pharmaceutical sector.

"Current laws do not usually grant exclusivity or patent protection to the manufacturer for conducting clinical research on a nutrient or vitamin—the molecule is available in the food supply so it is not unique," noted Steve Mister, president and chief executive officer of the Council for Responsible Nutrition (CRN). "As a result, dietary supplement research tends to be less driven by individual manufacturers and more by the scientific community at large, including academics and government institutions," he added.

Still a very young market, dietary supplement trials are typically performed either when regulatory requirements call for it, or if companies want to set their products apart from the rest by gaining the advantage of being able to make certain claims to consumers about their product's capabilities.

"The market has changed in our industry over the past 10 years...[it] was bringing products to market without a lot of backing behind it. But now industry is consumer driven and the consumer is asking for evidence to be behind these products," reflected Guthrie.

A piece of the pie

With global nutraceutical sales projected to reach $187 billion by 2010, according to Nutraceuticals World, a publication serving the manufacturers of dietary supplements, functional foods, and nutritional beverages, there may be incentive to get a piece of this market share.

In it's almost 12 year run, KGK Synergize has completed at least 60 dietary supplement trials, and currently has 15 ongoing—of which 80% of this business has been generated from U.S.-based companies. "Over the history of our company we had a cycle for a few years where we doubled in growth and then it's been about a 20% per year growth the past couple of years," Guthrie said.

Though Guthrie also mentioned the company experienced a slowing down recently, she noted that this was felt more on the pharmaceutical side of the company than the nutraceutical.

Companies can also expect a lighter load on cost and time in these trials. "Consumers are really interested in these products and are interested to know which ones are efficacious and safe and which ones are not," Guthrie explained. She told Applied Clinical Trials that her company has very little, if any problems with subject recruitment and retention.

The dietary supplement clinical trial market is "changing, it's changing slowly. But it's still nowhere near where it needs to be," Guthrie concluded.—Marissa Shapiro