“The move is definitely for more data, not less,” said Pam Coleman, President, Biofortis. “We tend to be more successful with experienced nutrition and supplement companies that understand the cost-benefits of clinical research.”
When Jay Udani, MD, founder and CEO of Medicus Research, first attended Natural Products Expo to interest vendors in clinical trials for their products, he recalls that people would ask what he was doing there.
“Back in those days, the conversation was, ‘This is why you need a clinical trial.’ The conversation now is, ‘This is how you do a clinical trial’.”
Dr Udani puts the dramatically increased demand for clinical trials down to two things: “Companies now understand the need for claims substantiation, and the ‘two clinical trial rule’ is now percolating throughout the industry, stating that only one trial may not be enough to substantiate claims.
“As a result, demand has significantly increased,” he said.
Product specific data
And there is also a demand from consumers for more accountability in scientific marketing, said William Rowe, President & CEO, Nutrasource Diagnostics Inc. “Product-specific data is the highest standard for marketing, health claims substantiation and regulatory approvals. It also shows a commitment to science and ensures that literature is not used out of context to support a product’s benefits.
“Product-specific data also allows for intellectual property to be developed around the product, its formula, and its effect.”
Talking the talk is not always followed by walking the walk, however. “We get a lot of requests from companies interested in research to substantiate their product, however, there is some reduction in this interest when they understand the scope of study – therefore costs – that is needed to support a desired claim,” said Jill Stocki, Director of Business Development for Biofortis.
There are a handful of CROs specializing in clinical trials in the supplement space, and they are a special breed of CRO, according to Dr Udani. “Pharmaceutical CROs cannot operate effectively in this space because the budgets are a fraction of pharmaceutical budgets (in some cases our budgets are considered a ‘rounding error’ to big pharma),” he said.
“Also, the knowledge required to design a clinical trial for a dietary supplement or functional food is very different than a pharmaceutical, because you have to have knowledge of DSHEA, you have to have knowledge of the IND requirements, and you have to understand that dietary supplements are not like drugs; they don’t function like drugs, and therefore they can’t be tested like drugs.”
The different CROs often position themselves with a different proposition. Stocki noted that Biofortis prides itself as being a “hybrid” CRO – providing a “high degree of expertise in nutrition science coupled with a successful publication record as is expected with universities and an independent business that delivers studies with unmatched speed and detailed focus on deadlines”. The CRO has locations on four continents: Europe (France), Asia (China), South America (Brazil) and North America (US), she said.
Nutrasource Diagnostics provides as vertically integrated, virtual R&D consulting service platform for the entire consumer health products industry, said Rowe. “Seamless integration of our GMP/GLP analytical, GMP/GLP bioanalytical, on-site clinical and complete regulatory services provides greater control and quality for our clients.
“By providing effective, global solutions, our clients are able to reposition existing products in new product categories, gain access to new markets, and take new products from concept to claim with very aggressive yet scientifically substantiated claims.”
“It is definitely worth hiring a clinical CRO that has vast experience with the nuances of the natural products and are familiar with and appreciate regulatory compliance issues,” explained Alexander Schauss, PhD, senior research director, Natural and Medicinal Products Research, AIBMR Life Sciences, Inc. “We have spent years communicating with the agencies such as USP, FDA, FTC, and Agency for Health Research and Quality (AHRQ), and converse with experts in the field, in considering what are the essential components needed in performing a successful quality clinical trial.”
Costs is a key factor in the selection process, and these are influenced by numerous factors, said the experts. “This is highly variable depending on what is being measured, the length of study, the number of time points, how the study is powered, the number of arms in the study and the cost of measuring the primary and secondary endpoints,” said Rowe. “A general range is $75K to $250K. NDI has developed a unique model for discounting and demonstrating return on investment for these types of trials.”
For Biofortis, the number one driver behind cost from its perspective is the study design, said Coleman. “One study design may require 2 visits of 60 minutes each while another may require the subjects to spend 8 days in the clinic for multiple hours each day.
“We suggest working carefully with the chosen CRO to optimize the study protocol since this drives the number of clinic visits, visit duration, visit timing (whether weekend or evening staff are needed), as well as the level of subject stipend.”
A second major driver is the need for specialty equipment or specialty laboratory assays, she said. Standard lab tests are a fraction of the study budget while specialty lab assays can quickly become a major portion of the budget.
Companies are definitely investing in trials, said Rowe, and he has observed a big increase in the desire for product-specific data as opposed to relying on someone else’s published literature.
“These include absorption, bioavailability, efficacy, effectiveness and safety studies in human patients either vs. placebo, vs. competitive products or both.”
Medicus’ Udani is seeing increases in trials based on regulatory activity. “When the regulators approach a certain regulatory field, that’s when trials in that area tend to increase the most.”