How do you differentiate your product on the market? Is it by having a superior quality formulation compared to your competitors’? Or by having an innovative delivery system that appeals to consumers? Both will assist in having a strong intellectual property (IP) position, but the ability to make claims substantiated by scientific evidence is the most effective.
With the rapid growth in innovation and product launches in the natural products industry, there has been an increase in human clinical trials being conducted to support both safety and efficacy for claims substantiation purposes. Although conducting a clinical trial may seem like a daunting and expensive task, it’s an important investment that will have a substantial return in the product’s life-cycle. A common question many ask is Where do I even begin? while you’re searching for a research partner, there are many factors you need to consider, these include:
- What is the objective of the clinical trial?
- What claim(s) are you looking to make on your product?
- What are your target markets and population?
- Are you interested in demonstrating safety, efficacy or bioavailability?
Once you have these fundamental questions answered, you can then address the more intimidating aspects of a clinical trial such as indication and design. Ensuring you have the right partner to help you navigate unknown territories will set the expectations and have the most appropriate design.
When choosing the right partner, the following should be considered:
- Years of experience, especially in the indication you’re looking at
- A partner that can strategically plan and understand your objective
- Protocol development, according to guidelines that are internationally recognized and accepted
- Scientific expertise — this is crucial, as your partner should be able to provide you with guidance on the most appropriate design, endpoints, duration, inclusion and exclusion criteria, and the ideal population to use in your study
- Recruitment is a critical step in any clinical trial; you should choose a partner that has access to the participant population you’re looking to study
- An understanding of your objectives and purpose of your study
- An understanding of the regulatory landscape of the market you’re looking to enter
- Works with a biostatistician to calculate sample size and recommend an appropriate number of participants for your study
- Understanding and experience in building a database and managing the data for your clinical trial
- A partner that can deliver a final report that’s detailed, interprets and explains your results and can be used for claims substantiation
- Your partner has published studies in the indication you’re interested in
Overall conducting a clinical trial takes preparation, realistic timelines, and an appropriate budget. Ensuring you are well informed before embarking on the clinical trial journey will allow you the opportunity to choose the right partner and gain the most out of the investment.