Clinical Trials
Your products work; it's time for them to become clinically proven.
The explosive growth in the natural products industry confirms that consumers are more determined than ever to take their to take their health into their own hands. They're looking for products capable of solving problems with stress, PMS, fatigue, gut health, cognition, sleep, immune support, and so much more.
You've got a product that solves one or more of these problems. But today's consumers want more than brand assurance; they want evidence. A clinical trial provides the evidence your brand needs to build consumer trust and help the world think, work, and live better.
ENDPOINTS
PROVING YOUR PRODUCT WORKS.
FOCUS AREAS
NUTRACEUTICAL-SPECIFIC OUTCOMES
EXPERTISE
NATURAL HEALTH SPECIALISTS
METHODOLOGY
PROTECTING YOUR TRIAL FROM FAILURE
PARTICIPANTS
GETTING THE RIGHT PEOPLE IN YOUR TRIAL
COMPLIANCE
ENSURING LEGAL WILL LOVE YOU!
ENDPOINTS FOR SUCCESS
Stress. Brain Fog. PMS. Fatigue. Natural products are used to resolve a myriad of important, yet clinically abstract, symptoms. There are no lab tests for stress or for PMS. There are no serum biomarkers to measure levels of fatigue. Rather than face this complexity head-on, many researchers instead focus on proxy measures. Blood pressure or EEG as a proxy for stress levels or invasive sleep labs as a proxy for daytime drowsiness. After all, these are the biomarkers everyone recognizes and respects.
The problem is: these alternative endpoints may indicate stress, but changes in heart rate or EEG can also be caused by a myriad of other, unrelated factors. These alternative endpoints were not developed to document changes to well-being among healthy people; they were developed to identify which patients have (or are at risk for) a particular disease. In pharmaceutical trials, they can measure whether or not a drug successfully treated a disease. But your study needs to evaluate a natural product, not a pharmaceutical. Your product improves health rather than treats disease.
To substantiate a product claim, you need endpoints that directly measure the target of the claim. Your trial endpoints need to match your product's effects, and most importantly, these endpoints shouldn't result in FDA warning letters.
So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical boosts abstract yet essential health-related outcomes? Nutraceuticals Research Institute helps you meet this challenge with our proprietary suite of psychometric measurement scales.
The Nutraceuticals Research Institute suite of measurement scales is the first of its kind developed exclusively for the natural products industry to capture improvements to abstract health-related outcomes among non-diseased populations. These comprehensive measurement tools focus on an extensive collection of predictors which are capable of providing objective data about the outcome in question. They also include outcomes related to the real-world factors that matter to your consumers.
Measurement can make or break your study
Why do you need these measurement tools? The endpoint you choose and the tools in which you measure these endpoints are the most fundamental and critical elements of your study's design. There's a reason both research methodologists and regulatory agencies such as the FDA emphasize the importance of endpoint measures. Measurement is the most important element of your research study. This measurement is the tool that will be used to capture and document any and all improvements to well-being that your product delivers.
There are three factors to consider with a measurement tool: validity (it measures what it is intended to measure), reliability (it does so consistently–time after time), and sensitivity (it is sensitive enough to capture even small changes in the specific effect). Collectively, these three elements determine the quality of a measurement tool, which plays a role in establishing whether or not it is fit for purpose.
When a clinical trial for brain supplements rely on dementia screening tools or a trial on stress relies on blood pressure, these researchers place the entire study at risk by using measures that are not fit for purpose. These tools might be valid and reliable, but they are not sensitive to changes among healthy people. They have a primary goal of screening patients or diagnosing diseases. They are good tools for diagnosing disease, but poor tools for natural product studies.
A successful natural product trial requires tools that were developed specifically for use in the natural products industry and are capable of documenting a holistic range of improvements in well-being among people who are already considered to be healthy.
Using the wrong tool to measure your outcomes puts your entire study at risk of a false negative.
Not only does having the right endpoint measure boost your trial's chances of success, it ensures that your trial meets the FDA and FTC's requirements for claim substantiation. These regulatory agencies identify appropriate and clearly measured endpoints as essential for successful claim substantiation. Outcome measures are also one of the primary criteria the FDA uses when evaluating the quality of a substantiation trial.
The use of a proxy measure that is not fit for purpose not only dramatically weakens the quality of your trial, it may even result in an inability to substantiate your claim. In extreme cases, it can even cause the FDA to reclassify your natural supplement or aromatherapy blend as an unauthorized pharmaceutical, opening the door to millions in compliance-related costs.
How we design your trial
Nutraceuticals Research Institute reduces this vulnerability by exclusively relying on our proprietary suite of fit-for-purpose endpoint measures which our team developed specifically to meet these FDA and FTC guidelines. Our comprehensive scales capture a wide range of symptoms, including both objective and subjective factors associated with the primary outcome.
These outcomes are measured through real-world effects, ensuring that your study findings not only keep regulatory agencies happy, but that they meet the desires of your customers. Your customers want to know if your product helps them with practical, real-life issues. We help you achieve that.
FOCUS AREAS
WE ARE NATURAL HEALTH PEOPLE TOO
One of the biggest challenges to natural product research is finding someone who understands both the natural health field and clinical research. Most research firms are pharmaceutical firms first, with nutrition or supplement research as a side gig. These firms simply take the same assembly line approach and cram your unique cognitive enhancing product into a preexisting strategy. But your highly complex natural product isn't a drug. Your endpoint isn't a disease. Cramming it into these study designs falls short when it comes to capturing what makes your oil blend or natural product actually work. The end result is usually an outrageously expensive trial that suffers from poor quality design and ultimately ends in failure.
As a natural health research firm, we take a different approach. Each and every researcher on our team is also a trained natural health professional. Our team includes aromatherapists, herbalists, health coaches, dietitians, and a range of other specializations that cross the holistic health spectrum. We know the interactions between substances such as botanicals, nutraceuticals, or essential oils, and memory, stress, fatigue, or other outcomes. This allows us to understand your product in ways no other firm can. We know your product doesn't rely on pharmaceutical-like mechanisms of action or protocols, and we won't treat it that way.
If your product is an aromatherapy blend, our expert aromatherapists will work with you to ensure that every element of your study maximizes the unique chemistry your oil blend has to offer. If your product is a supplement, you'll enjoy researchers who are nutrition experts and herbalists. You'll never have to explain the phytochemistry or holistic approaches your product uses to achieve its goals. We know how to maximize your product's effects, boosting not only your chances of success but the level of success your trial achieves.
As experienced natural health professionals, our team is also familiar with the ways in which natural products are inadvertently misused. We know how to ensure that your aromatherapy blend is dosed sufficiently and applied consistently from day to day. Our culinary experts know how to keep participants consuming your supplement even if they don't like the flavor or texture. These factors are often overlooked by conventional firms but have the potential to make or break your trial.
WE BOOST YOUR CHANCES OF SUCCESS
Not only will you enjoy the expertise of holistic health experts, your trial will be managed by highly trained clinical researchers. Our research firm is led by a Harvard-trained researcher and each of our team members have graduate training in health research fields. This ensures that your trial meets the highest scientific and methodological standards.
This expert approach to trial design reduces your chances of a false negative. Far too many natural product trials fail not because the product doesn't work, but because the trial was poorly designed. These problems can involve a study being underpowered, poor choice in endpoint measures, inability to develop an effective intervention protocol, participant dropouts, or sloppy data analysis.
At Nutraceuticals Research Institute, we use our extensive expertise to make you look good. We create clinical trials based on your product's strongest effects. We ensure that the endpoints for your trial are hand-selected to match the effects your product actually delivers.
Far too many natural product trials fail not because the product doesn't work, but because the trial was poorly designed.
Our power analysis standard cuts your chances of false negatives in half. In an effort to cut costs, many firms conduct studies that are developed to accept a 20% chance of producing a false negative. Roughly 1 in 5 trials are at risk of falling short of statistical significance simply because they are the wrong size. We cut that risk in half, designing high powered studies that are more likely to succeed.
Many others fail due to poor intervention strategies. Doses that are too low, schedules that are too complex for participants to follow, inconvenient preparations, or even improper application approaches can all lead to false negatives. When this happens, the problem isn't that your product doesn't improve memory or brain health, the problem is that most researchers don't know how to help study participants use your product correctly. Our health experts create user-friendly intervention strategies which address all of the complex factors that contribute to study success.
We also develop comprehensive statistical analysis plans that eliminate the noise from your data, isolating your product's true effects. By using simplistic measures, many research firms are incapable of data analysis that sufficiently captures the effects your product can deliver. Our natural product expertise allows our statisticians to identify and neutralize factors which can minimize the effects, producing trial results that accurately display the true size of your product's product's effects.
ENROLLING YOUR TARGET MARKET
To meet regulatory requirements, your trial needs to establish that your product boosts health, not that it treats disease. Your task is to document improvements to health in people who are technically already healthy. But let's be honest, your customers may be disease-free, but they are not healthy. If they were, they wouldn't be searching for your help!
That's why identifying the right people to enroll in your trial is critical. Our multidisciplinary team includes public health professionals–experts who can pinpoint exactly who is most likely to demonstrate the largest benefits from your product. By targeting disease-free people who want improved health, we're able to capture the individuals who are most likely to buy your products and who are most likely to benefit from your products. This boosts your trial's chances of success while also meeting the FDA and FTC requirements.
Claim substantiation also requires that the people in your study's trials match the people who consume your products. Different people respond differently to natural products, so it's critical that the people in your trials are similar to the people who will actually use your essential oils, herbal products, or nutraceuticals. If your product enhances memory in college students cramming for tests, your trial needs to be conducted on college students during final exams. If it's for middle aged women with fatigue, it needs to be conducted on middle aged women.
Enrollment, Protocol Compliance, and Drop-outs
Identifying the right group of people to participate is one thing; getting them into the study and keeping them in a study is a whole different ballgame. Across the industry, over 80% of clinical trials are unable to meet enrollment goals; this inadequacy is a leading cause of study failure. Some firms address this challenge by lowering their standards–enrolling anyone and everyone they can find into a trial. This approach looks great at first, but the resulting poor compliance and large drop-out rates destroy the quality of a study. This introduces a form of bias to your dataset, dramatically reducing the quality of the trial and therefore, the potential for your trial to substantiate a claim.
Keeping people who enrolled into a study involved in the study and using the product correctly is critical for your trial's success. You already know that people need to actually use your product to experience its benefits. If the people in your study are only sporadically taking it or sloppily using it, the resulting data will be unable to validate your product's effects. Similarly, large dropout rates will also reduce the quality of your study while increasing the risks of a false negative.
Our Unique Community
Nutraceuticals Research Institute takes a different approach to enrollment and retention. Rather than simply accepting noncompliance and dropouts as inevitable, we've invested in the cultivation of a large community of willing and eager volunteers who want to join your trial. The community we've built is also demographically consistent with the populations most likely to purchase natural products for conditions such as stress, memory support, or PMS.
By focusing on the participant experience, we're able to find the right enrollees for your study and keep them engaged throughout your trial. The end result for you? Recruitment costs that are a fraction of industry norms. Not only that, we average a 99% retention rate in our trials with near perfect protocol compliance.
LEGAL WILL LOVE YOU
One of the most important reasons to conduct a clinical trial is to boost protection from legal challenges. If you want to say your product improves memory or boosts mental acuity, the FDA and FTC require you to bring the evidence. Not just any evidence; they require high quality evidence that meets key criteria.
The FDA identifies these criteria as: study population, study design and conduct, data collection and statistical analysis, and outcome measures. You may have a "successful" trial but if it doesn't meet these quality-based criteria, it doesn't substantiate a claim.
Unfortunately, poor quality trials are common in the natural products industry. Many large firms aren't equipped to manage the unique elements of natural products or to prioritize health-enhancing outcome measures and FDA guidelines. Others may use dubious techniques such as "p-hacking" or conduct multiple analyses without controlling for multiplicity. These may give the appearance of success, but ultimately fail to meet industry standards.
Here's the catch. Regulatory agencies can easily catch these common mistakes. Quick and cheap trial results that use shoddy statistical approaches don't fool expert statisticians. Neither does a long and overpriced trial conducted by drug researchers who know nothing about natural products. And when these trials are evaluated for quality, your company will be the one that pays the price.
We take our commitment to the integrity of your trial seriously. The overwhelming majority of our studies are published in peer reviewed literature and/or presented at academic or scientific conferences. This not only provides valuable free press for your cognitive enhancing product, it also provides additional evidence that your trial is high quality and capable of substantiating your claims.
Not only do we keep quality at the forefront of what we do, each of our trials are backed by our Five-Point Promise, which details our commitment to ensuring trial outcomes that work, sample populations that matter, natural health expert researchers, high quality research methods, and direct access to researchers–not high pressure sales people or account managers. By focusing on quality over quantity, we're able to deliver high quality clinical trials faster and more affordably than any other firm in the natural products industry.
YOU KNOW YOUR PRODUCT IMPROVES HEALTH; WE'LL HELP YOU PROVE IT.
Schedule a free, no-obligation meeting with a scientist today to learn more about how Nutraceuticals Research Institute can help your product become "clinically proven."