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Clinical trials – time for finished product manufacturers

Pharmaceutical companies entering the nutraceutical market are setting new standards for our industry. For them, proven safety and efficacy of finished product is a prerequisite. To compete, nutraceutical companies will inevitably have to invest in quality clinical research to back finished products' health claims.

I – Current practices

Ingredient manufacturers are increasingly investing in clinical studies to substantiate their ingredients’ benefits on health and differentiate their product on the market. However, it is far less common to find clinical evidence for finished products’ health benefits. A large portion of the nutraceutical market still consists of commodities, relying on bibliographical data or historic use for proof of efficacy. Understandably so, since there was no pressure forcing supplement manufacturers into clinical substantiation. This, however, is rapidly changing.

With the rising segment of educated and proactive consumers, such bibliographical substantiation is losing credibility. In segments such as deficiencies, prenatal nutrition or immunity, we are seeing cases globally where consumers recognise products with proven added value and are increasingly prepared to invest in it.

On the other hand, pharmaceutical companies entering the nutraceutical market are setting new standards for our industry. For them, proven safety and efficacy of finished product is a prerequisite. To compete, nutraceutical companies will inevitably have to invest in quality clinical research.

When the time comes, significant expertise will be required to define, carry out or monitor a clinical trial that will bring added value to the product.

II – Ideal design of a clinical trial 

Prior to conducting the actual clinical research, it is advised to carry out a pilot study on a smaller number of subjects. This generally helps ensure that the type, timing and magnitude of measured response are well-defined and can guide the design of the actual trial. Once the study design and the pre-planned statistical methodology are ready, inclusion of a sufficient number of healthy or at-risk test subjects, should be performed using correct inclusion and exclusion criteria. This step can be problematic and the point where compromises are made. Pressure for quick execution and cutting costs too often drives companies to settle on low numbers of participants. This, however, is one of the first parameters an educated professional will examine and the credibility of the entire study could be compromised. 

Study timing, duration and testing locations are also important parameters and the most neglected in trial design. While double-blind, randomized and placebo-controlled design is slowly becoming the standard, conducting multicentric and multi-seasonal clinical trials is the next step. Multiple testing locations enable researchers to evaluate the importance of demographic factors and reduce bias, on the whole increasing the generalisability of the study results. Especially for season-affected studies extended duration should be considered. In the case of a clinical trial on PharmaLinea’s liquid immunity product for children, multiple seasons and testing centers were encompassed within one study in order to eliminate the variable influence of location and flu seasons on results. While this presents a substantially larger investment, we believe it was the necessary step that not only enables the medical representative a different level of credibility in front of doctors and pharmacists, but also helps ensure end-users positive results regardless of the location or season.

III – Yesterday’s advantage, tomorrow’s necessity

With the recent decrease of revenue generated by small molecule drugs, pharmaceutical companies are expanding into new categories. It has gone from theoretical phenomenon to very tangible statistics we collect at nutraceutical trade shows. Our industry is undergoing an important change and so will the composition of products on the shelf. To avoid being pushed into price competition, clinical substantiation of finished products will become a necessity for companies from all backgrounds, not only pharmaceutical. This is confirmed by several examples of seemingly very different clients of PharmaLinea – the number one Swiss OTC company, the number one Belgian food supplement company, the leading Spanish infant nutrition company, as examples – who already chose this path and have successfully leveraged clinical substantiation of our products on their markets.

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