“Is so important to work as a team when doing clinical research, It is important to design the clinical trials so that the endpoints are something that marketing can work with,” Lauren Clardy, principal of the marketing consulting firm Nutrimarketing told NutraIngredients-USA. “What I find so often is companies that will come to me with an amazing ingredient with a lot of information and some neat research behind it but it is coming at it from a pharma perspective.”
Clardy recounted an interaction with a client whose team was headed by an internationally recognized scientist. The company had already done some research on the product, and was planning to do more. But Clardy said, from her perspective, it would have been a case of throwing good money after bad, because the studies that had already been done and the new ones in the pipeline all had disease endpoints.
“I told them, just stop. Take a step back and look at what we are trying to accomplish. What data do we need to support a claim on the product?” she said.
Gathering the right data
Having an eye toward the eventual claims should drive all parts of the process, said Ivan Wasserman, a managing partner with the Manatt law firm. And that includes the literature search.
“You’d first do a literature search to see what information might already be available on the ingredient or formulation in question. You can then assess that body of literature to see if it is sufficient to support claims and if those claims meet the company’s marketing goals,” Wasserman said.
“As far as a study for a supplement it is important that it have a clinically meaningful endpoint. For most health benefit claims the gold standard, which we advise most clients to meet, is to have at least one and preferably two randomized controlled clinical trials to support a claim,” Wasserman said.
Choosing what to go after in these studies is where the team work comes in, Clardy said. Sometimes study designs can be tweaked without much extra cost to include endpoints that will help support the marketing of the product.
“If you are already spending something like $300,000 to get the study done, it might only be a few thousand more to include some things the marketing department wants,” Clardy said.
It’s also critical to take the temperature of the market for a given ingredient, Clardy said. It might smack of allowing your competitors to set your agenda, but if in a given class of ingredient competitors are spreading the word about how their ingredients perform on a certain measure, it can be a handicap if that measure isn’t included in a study. Clardy said she has seen this mistake play out in practice, and it leaves the marketing department with nothing to say when that question comes up.
FTC is watching
Wasserman said high quality study design is critical both to achieve what the company is paying but also to stand up to FTC scrutiny, which is becoming ever stricter.
“The FTC can and does critically review a study to make sure it follows all the right procedures. But they will go a step further these days and do a paper audit of the study and request all the raw data, all the back up data. If they can get them, they will also want the case report forms, the occasions when data was recorded such as when tests subjects came in, were weighed and had blood drawn. They are looking for intentional and unintentional data screwups,” Wasserman said.
“They are looking to see if you used the right controls, the right randomization procedures, the right statistical analyses. They will also look at the tools you use to assess things like pain, quality of life and memory,” he said.
Relevant study design
Jay Udani, CEO of contract research firm Medicus Research, said choosing the right endpoints is what makes for a study that will pass critical review but will also yield something that can aid in the marketing of the product.
“From a strategy standpoint its all around how you design study a that is compliant with DSHEA, does not trigger an IND requirement and with endpoints that are relevant to the consumer,” Udani said. “For instance, if you are using cytokines as markers of inflammation, I don’t think that really connects with a consumer.”
Udani, who spoke on the subject of compliant research at the recent CRN conference, pointed to a recent study his organization did on a joint health ingredient. The study design stressed the participants via a treadmill test and then compared the joint comfort of placebo and test groups, showing how much longer the test group could exercise without joint discomfort.
“Do it that way, you can make claims specific to a certain percentage improvement in joint health. Consumers can understand how these kind of results relate to them. I have spoken to some lawyers who call them DSHEA studies,” Udani said.