Clinical studies can be expensive, time-consuming and risky. Potentially riskier and costlier, however, is not conducting clinical trials. The clinical trial industry is mature enough that there are well-defined approaches to minimize study risks and maximize returns on investment. Human studies, when managed appropriately, can drive business success.
Timing Can Save Money
Timing is a critical component to a successful clinical trial; bad timing can surely sink a good investment. Of particular importance is preparedness. Before starting a human clinical trial, the study sponsor should know:
- The product’s lowest dose that is likely to produce the health benefits;
- Its most prominent expected health benefits and, more importantly, those that will lead to differentiated claims; and
- The minimum time required to demonstrate the product’s primary and secondary benefits.
If this information is lacking, funding an “exploratory study” or collecting consumer feedback from marketing history can help gather the necessary information. The dose, onset of action, time to maximum effect, primary actions, most likely target groups and any safety concerns can all be determined through marketing history if one has been observing diligently for long enough. Such relevant and credible feedback can also be collected from users via organized online surveys. A well done, free survey prior to an initial clinical trial can save money while providing necessary insight if analyzed appropriately.
Clinical Strategy vs. Clinical Study
Some may protest the proposal of two clinical trials to substantiate claims; however, it’s advisable to always plan for two, not one. A firm may be tempted to throw its entire budget into a single clinical trial with all the frills, including a decent sample size. But when there is very little data prior to conducting a clinical trial, it may be too risky to go straight into a single, final study for marketing. Instead, a stepwise approach is advised: First explore what a supplement can do best, and only then invest in a well-powered confirmatory study. Exploratory studies can be designed to examine several doses, types of consumer groups and measurement time points, as well as more than one clinical outcome. Exploratory studies, if designed well, can throw light on the minimum and maximum length of exposure that should be planned in the confirmatory study. Invaluable data can come out of exploratory studies, such as the impact of the health effect of the product versus placebo. For example, if an exploratory study evaluating the effects of a pre-workout supplement showed an increase in VO2max (a measure of maximal aerobic capacity) of 3 percent after supplementation, but also showed an increase in VO2max of 1 percent in the placebo group, the difference between the impact of the product versus placebo was only 2 percent. This information helps optimize sample size for the confirmatory study, thus balancing study power and costs. It is also a good strategy to test a product being studied for the first time in humans on a small number of volunteers, rather than conducting a large study and discovering unforeseen safety concerns.
Initial setup costs for several activities, such as documentation, site setup, trial supplies, etc., can be significantly reduced when both studies are planned together, or at least when a provision is made for a second one. Firms with this foresight will not consider the second study a burden, but rather the second stage of a two-stage rocket that propels its business more effectively into the stratosphere. Each stage serves a purpose.
It’s a Numbers Game
Sample size is a key determinant of project costs and project success. Calculating the sample size depends primarily on the expected difference between the effects of the supplement versus placebo control. The placebo’s effect can sometimes be assumed from past published studies on similar products that used a placebo control, but the effect of a company’s own product can be derived only through prior research such as exploratory studies, animal or in vitro studies. Savings can be maximized if statistical significance can be achieved through 90 volunteers in a study instead of 100.
Further, not all volunteers screened during recruitment enter the study. Every volunteer that fails to meet the study criteria adds to the cost of “screening failures.” Likewise, not every participant who enters the study will complete it. Study participants may be “lost to follow-up,” withdrawn due to safety or tolerability concerns, or may drop out voluntarily if no longer interested in participating. This natural attrition at each stage can vary from 5 to 20 percent, adding to clinical trial costs. Contract research organizations (CROs) may have strategies to limit this failure rate. Study sponsors should discuss these issues with the CRO to jointly arrive at more favorable numbers to control study costs.
Time Is Money
Recruiting adequate participants for a study takes time, but can be managed to reduce costs. Multicentric studies encouraging competitive recruitment can help reduce time to recruit volunteers. Working with a carefully chosen CRO that can accelerate study completion helps generate sales revenues earlier. CROs can offer strategies and tactics to speed study recruitment, build contingency plans and adhere to timelines despite unexpected surprises. It’s up to the study sponsor to carefully investigate potential CROs before entering a partnership to ensure the CRO is experienced in managing study timelines to maximize costs.
Contrary to jingoistic claims, offshoring of certain low-wage business functions to cost-efficient locations not only helps the destination country, but can also help the United States. Neither FDA nor FTC are opposed to foreign studies, as long as they are well designed and the study group is chosen carefully to represent group being targeted for marketing. The classic and most profound way of limiting clinical trial costs and ramping up speed is by offshoring to destinations such as Eastern Europe and Asia. Some Asian countries have highly developed medical schools, hospitals, CROs, a well-established regulatory framework and entire ecosystems for clinical research. The business advantage of conducting human studies in these regions outweighs the initial efforts involved in evaluating a provider there. Studies can be managed remotely, but an initial visit prior to the start of the study is advised. Asian science and technical capabilities are now globally accepted. But the dietary supplement industry has not yet fully leveraged this advantage, other than the sourcing of botanical ingredients from countries such as China and India. This potential can also be tapped.
Asia can offer lower costs on two of the biggest expenses in clinical trials—investigator costs and lab tests. Pilot/exploratory studies or larger confirmatory studies can be conducted in Asia. Countless U.S. firms and multinationals have been using this to their advantage for last two decades. This is one viable option to boost clinical research to win consumer trust.
The next time a business is cutting research spending to save for the big-dollar ad campaign, it should stop and consider how to get the best of both worlds. Advertising efforts can be boosted with proprietary human studies rather than borrowed science. An efficiently managed clinical study may well become the best investment a company makes in its nutraceutical business.
Jayesh Chaudhary is a co-founder and CEO of Vedic Lifesciences, a “verifiable” CRO serving the nutra industry for more than 17 years. He is among the pioneers who brought good clinical practices (GCP) and other stringent standards to natural product research.