NIE asked ingredient suppliers to highlight the pitfalls and challenges that can be encountered when implementing human clinical studies. Even more importantly, what are missteps that finished product manufacturers should be wary of when vetting ingredients for their products, and what ingredient companies may encounter when pursuing human clinical backing.
Here’s what they had to say:
“Science bar none is the greatest ROI if the data is good and relates to condition specific areas for which claims can be made. With that in mind you make considerations so focus your attention and resources on those things like research will provide you with the greatest return. Pitfalls and challenges come in all sizes when it comes to clinical trials. You want to make sure the dosage is enough to see efficacy but not too much that the dose is too expensive or that compliance is going to be an issue with consumers.
“From a finished product manufacturer perspective, you want to look for a well-designed clinical trial that shows statistically significant data in appropriate populations and published in peer-reviewed journals.”
— Suzanne McNeary, President, NutraGenesis, LLC. (Brattleboro, VT)
“Helios CORP believes that the biggest risk for end user manufacturers is getting deceived by the presentation of inferior studies. There are many claims these days from companies that [insinuate] to having Phase I and Phase II human clinical studies. The question is ‘Who is going to fly overseas to validate the integrity of these studies?’
“From our perspective, the easiest way to solve this is for the end use manufacturer to expect a full U.S.-based Phase II human clinical study with evidence that the test site was registered, unbiased and can validate in writing that said data was a results of an honest clinical study.
“We are presented with multiple studies per year where companies want us to flesh out their science and claims. The craftsmanship of some of these studies is unfortunately inferior and yet a year after we rejected the study. I see the ingredient in market—scary stuff for the nutritional industry.”
— Michael Jeffers, CEO of Helios CORP (Santa Fe, NM)
“The body of research provided by the manufacturer of the raw material should be carefully reviewed and evaluated by the finished product manufacturer. Typical missteps are to use borrowed research, advertorials instead of peer-reviewed papers or otherwise legitimate clinical research data. Only peer-reviewed papers should be utilized in the process of vetting the raw material for a quality finished products.
— Vladimir Badmaev, MD, PhD, head of R&D, NattoPharma (Oslo, Norway)
“When times get tough, most companies will slash R&D. While this behavior is understandable, it is not how ‘breakout’ strategies are formed. Companies that consistently support R&D efforts generally become the industry leader, and thereby attract the best talent in the industry and generally gain access to the better business development partnerships.”
— James Lugo, PhD, director of R&D with InterHealth Nutraceuticals (Benicia, CA)
“There are lots of pitfall or challanges. They start with study design. It seems that no one is a true expert on study design so you can get lots of opinions on what makes sense. It’s also a challenge to get personnel for national research organizations to review study protocols and comment as to the potential relevance. Design issues include crossover or non-crossover, how many legs of the study (re dosages), resource medication use, tracking dropouts and poor tolerance reports and so on.
“Surprises and delays are common, communication is key. Then be patient as publication can take a while for the peer review process. And ultimately, even many in the medical community (MDs, DCs, NDs, pharmacists, etc.) don't know how to review and understand research or what is good research and what is perhaps questionable! It’s okay, as having the research foundation will help you, the producer, sleep better at night if your product claims are substainiated (I know a friendly competitor whose claims were not substainiated!) Isn't that worth the price?!”
— Michael Bentley, President, SierraSil Health Inc (Vancouver, BC, Canada)