- Clinical trials -

Cognitive

Well-Being

Quantify your product's effects on working memory, mental acuity, brain function, and even post-COVID-19 brain fog.

 

clinical trials for your brain boosting product

The global brain health supplement market topped $7.5 USD billion in 2020. Cognitive support is important to consumers, but only if they can trust the product.  

Consumer trust is harder than ever to earn. Brain health consumers are tired of wasting money on products which fail to deliver real world benefits. Earning their trust requires scientific evidence that your product will help them with the practical problems they experience every day–keeping track of where they parked their car, focusing on conversations, and remembering birthdays and appointments. 

This evidence requires RCTs–randomized controlled trials–the gold standard of clinical research. But until recently, RCTs have been out of reach for many natural product companies. 

Historically, clinical trials for brain health have required extensive budgets to spend years conducting invasive brain imaging tests. Or they have relied on outcome measures such as dementia screening scales that fail to capture the benefits of natural products. This outdated, inefficient approach is high on risk and low on reward.

Your cognitive enhancing products require cutting-edge and intelligent research designs capable of capturing their full potential. Our expert scientists at Franklin Health create customized RCT protocols capable of demonstrating your products most powerful effects. This forward-thinking approach to clinical research provides you better results that are faster and more affordable. 

0%

of typical nutraceutical clinical trials fail to meet enrollment goals

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study participants are in the Franklin Health database

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is the risk of failure typical clinical trials accept

we make your brain boosting products look good 

When it comes to clinical trial outcomes, size really does matter. Clinicians and regulatory authorities alike want to see not only that you reached statistical significance, but that your product delivers an effect large enough to provide noticeable improvements. The effect size matters. 

The effect size captures the magnitude of your product's brain boosting activity, telling consumers and clinicians just how much cognitive support your product delivers. 

When our team of research experts creates your trial, we focus on capturing the largest effect size your product can deliver. 

Our researcher team includes experienced integrative health professionals, so we are intimately familiar with the relationship between phytochemicals and cognition. This expertise allows us to accurately identify how to display your product's greatest strengths. We hand-select the study population, choosing people most likely to experience substantial brain boosting benefits from your formulation's specific mechanisms of actions. And we develop intervention protocols customized for your most powerful ingredients, enabling them to show off their biggest effects. 

 

Our expert approach to trial design cuts the risk of false negatives in half 

When it comes to cognitive health trials, risk reduction is the name of the game. After all, the greatest threat to your research investment is a negative outcome.

Sometimes a negative outcome means that your product needs reformulation or adjustments to dosing, but most natural products have negative outcomes because of common mistakes in protocol development. For example, most clinical trial designs accept a 20% chance of producing a false negative and use simplistic statistical analysis plans that are incapable of capturing complex yet positive results. 

Our research methods experts cut those risks in half, designing high powered studies with advanced statistical analysis plans. While no ethical clinical research organization can guarantee success, this approach dramatically minimizes the chances of a negative outcome due to trial design. 

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focus on the outcomes that matter to your consumers 

The right clinical trial creates consumer trust, giving them confidence that your product actually boosts brain health. Many clinical trials, however, focus on outcomes that don't matter to your customers.

Far too often, researchers focus on subtle changes in brain activity that can only be seen by advanced imaging. These findings may be fascinating from a scientific perspective. But when your consumers stand in the health food store deciding between brands, what they really want to know is which product will help them remember where they parked their car. They need real world health benefits, not scientific jargon or benefits which are too small to deliver real world effects. 

Our brain health trials use the proprietary Franklin Cognitive Health Scale, developed by our team of psychometricians, statisticians, and healthcare experts to capture improvements to cognitive health for the natural products industry. This comprehensive measurement quantifies your product's effects on six distinct areas of cognitive health: brain fog, mental acuity, memory, brain function, psychological impact, and quality of life. Precise information about the size and location of the effect of your product provides the most accurate and scientifically solid substantiation for your product's claims.

In other words, we measure the real world outcomes that your consumers care about. We produce evidence that your product enhances memory, allows them to accomplish more in their day, and improves their lives. This allows you to make claims related to the real world benefits that your customers need most. 

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CLINICAL TRIALS ON YOUR TIMELINE AND WITHIN YOUR BUDGET 

By focusing on trial design and quality, we cut the average time required for an efficacy trial from 2 years to less than 1 year. Rather than wasting months building antiquated and costly infrastructure for recruitment and data collection, we utilize modernized streamlined processes, focusing our time and efforts on the quality and integrity of your trial. 

Your cognitive health trial will always begin with 4-6 weeks of customized protocol development with our expert team of dietitians, herbalists, statisticians, and medical professionals. This is the most important phase of the trial. After regulatory authorizations which take 1-2 weeks, our team recruits and trains a highly specific group of participants from our extensive database.  

Next, participants begin providing informed consent and start taking your product. Most brain support supplements need to be taken for 3-6 months to produce substantial changes. During this time our team collects data and runs frequent quality control checks. These data are then analyzed with findings presented to you in multiple formats. From contract execution to manuscript delivery, brain support clinical trials take an average of 6-12 months total. 

Eliminating inefficiencies in the process means eliminating associated costs as well, making trials more affordable. Logical and intelligent clinical trial design not only boosts quality, it reduces overall cost, helping your research budget go even farther. 

unlock brain health claims  

Conducting a clinical trial on your brain boosting supplement delivers a substantial return on investment. With a published clinical trial, you can obtain scientific substantiation about your product's effects, allowing you to legally and ethically make claims that your product is clinically proven to improve brain health, reduce brain fog, improve memory, or reduce absentmindedness.  

Obtaining documented evidence of your product's effects translates to increased consumer confidence in your product's efficacy. Scientific substantiation is also important to have on hand should the FDA or FTC come knocking; the best protection from regulatory issues surrounding your product's claims is to have high quality clinical trials specific to your product and your target market.

With Franklin Health's clinical trials expertise you can unlock new claims and gain consumer confidence, setting your product apart from the competition. 


 

 

Clinical Trials for Brain Boosting Products

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