What does it cost to have FHRF conduct a study for our product?2019-06-19T14:54:33+00:00

Studies on herbal, dietary, and aromatherapeutic products are much more affordable than many people believe. The actual cost of a study can vary dramatically depending on the population being studied and the effect size of the product being tested. Natural product studies are often a small fraction of the cost of pharmaceutical drugs because they have a lengthy history of public use and a low-risk safety profile.

For example, some small pilot studies can be conducted as little as $25,000-$30,000, while large-scale phase 3 clinical trials with an IND may exceed $300,00-$500,000. Final cost of a project is determined by the effect size of the product (which dictates total sample size), the specificity of the target population, the average time-to-effect duration, overall safety of the product, and regulatory status.

We encourage you to reach out for a free consultation with our research team to discover how we can customize a research project to your target budget.

How long does it take to get a quote for a study?2019-04-24T21:25:29+00:00

The first step to initiate a project is to schedule a free one-hour consultation with the research team to discuss the scope of your project, your budget, and your overall goals. The research team will then invest time studying your product, your proposed use of the product, and information about your product’s ingredients that are already established in the scientific literature.

This will then be used to produce a quote that outlines the best methodology to answer your research question within your unique budget. You will receive information on the outcomes to be tested, the required sample size (which is determined by a power analysis of the active ingredients and the outcome of interest), the proposed timeline, and the total cost of each phase of the project.

This process typically takes 1-3 weeks, depending on the complexity of your product’s formulation and the project itself. A quote is valid for 30 days.

When are the funds for a study due?2019-04-24T21:24:56+00:00

A project is billed as it progresses from each stage to the next. Here is an overview of how a project is billed:

Start Up Costs: Immediately upon contact execution

Per Subject Costs: When your study reaches the implementation stage, you will receive an invoice on the final day of each month for the participants recruited in that month. These invoices are due within 30 days. The timeline proposed in your quote provides a rough estimate for the time required for participant recruitment.

Completion Costs: Within 30 days of the study’s conclusion.

Note: Completion costs must be paid before the final manuscript is presented.

Will you protect our company’s intellectual property?2019-04-24T21:24:32+00:00

Intellectual property is fully protected in the research agreement. You retain all rights to all intellectual property that was owned prior to the research study.

What happens if the clinical trial finds that our product doesn’t work?2019-04-24T21:24:00+00:00

Investing in clinical research for your product is betting on your product’s efficacy. Due to research ethics, we do not guarantee any specific outcome. It is possible that, when tested, your product is no more effective than placebo. It is even possible that your product is found to worsen the outcome. Our research team addresses this in multiple ways:

  1. Our team does not initiate studies on products we do not expect to improve outcomes for participants in our research. This is not merely to boost outcomes. Conducting human research on products which are unlikely to work violates research ethics. Prior to initiating a human clinical trial, our team evaluates lab and animal studies featuring active ingredients in a product. We also evaluate other human studies. If we do not have ample evidence to support the safety and probable efficacy of your product, we will not produce a quote for your project. We will work with you to evaluate a different product in your product line or to explore outcomes that are safer and more effective.
  2. All of our researchers are herbalists and/or aromatherapists. This content-specific expertise allows the team to independently evaluate safety and potential efficacy of products.
  3. For pilot studies and phase 2 studies, our protocol development includes multiple outcomes with as many as 20-30 total evaluation measures. This accomplishes two things: it ensures that our team discovers effects of the product by measuring the outcome through multiple methods. This can provide specificity identifying how your product affects an outcome. This also allows the research team to identify where the product is the most effective so that future research studies can prioritize the outcomes that produce the largest effects.

For example, in a study evaluating an essential oil blend on fatigue, our team utilized a 10-part fatigue measurement to evaluate multiple forms of fatigue. The study found that the blend reduces general and global fatigue far more effectively than physical fatigue. A study with physical fatigue as a single outcome would have produced a false positive on the blend. This multi-outcome approach is far more complex but enables you to discover how your product is producing those effects and where to invest future research funds.

When a study finds that a product does not achieve its intended goals, we encourage companies to explore where these findings are just as valuable as findings that identify efficacy. Information regarding where the product is less effective or outcomes the product does not achieve provides important insight for the R&D team to identify where future innovation is needed for product improvement.

In keeping with research ethics, all human participant studies with outcomes that would influence the practice of natural health are disseminated, whether or not the findings are beneficial for your company. Our studies are submitted to scientific journals for publication, to conferences for presentation, and/or through other means. We do not, under any circumstances, hide or “bury” findings for any reason. Dissemination occurs after findings are presented to the company and after a 30-day preview period in which you have the opportunity to review any manuscripts or presentations to confirm that intellectual property is not released along with the findings.

How quickly can our study get started?2019-04-24T21:22:45+00:00

This is the timeframe in which our team obtains ethical authorization, develops the study protocol, registers the study (if applicable), and manages all of the necessary regulations for legally and ethically conducting your study. This process can take between two and eight weeks, depending on the complexity of the research project. Studies that do not include human subjects can be started within 2-4 weeks.

What legal authorization does a clinical study need?2019-04-24T21:22:18+00:00

All studies which involve human subjects, even if there is no intervention, must receive IRB approval before any participant is recruited. Additionally, studies which evaluate medical claims must have an active IND with the FDA and receive authorization for the study protocol. Clinical trials must also be registered with a recognized authority. We manage the entire legal authorization process for your study and can have it recruiting subjects within 2-8 weeks of an agreement.

What kind of studies do you conduct?2019-06-19T14:58:08+00:00

FHRF is a clinical research foundation. We conduct epidemiological studies on the risks and safety of products and exposures, clinical trials, and meta-analyses. Most contract projects involve clinical trials on specific products, such as an essential oil blend, a dietary supplement, or a topical product.

We also offer consulting services that involve substantiation of product claims, FDA authorization processes (such as IND and NDA applications), and ingredient efficacy/dose determination. These are billed on an hourly rate.

We do not conduct bench/laboratory research or animal studies. Our team works primarily with human participants and the clinical effects of products within the human body. Similarly, while we are available for expert consulting for product efficacy and safety during the R&D stage, we do not offer product formulation services or brand endorsements.