See how our expertise makes clinical research budget-friendly
Clinical trials in the integrative health world are typically seen as luxury expenditures, far exceeding the budgets of most companies in the field. After all, a research team is required to design and conduct clinical trials that adhere to FDA and FTC regulations, provide methodologically-sound results, and demonstrate superiority of your product as compared to a placebo or alternate standard of care.
However, integrative health studies are typically a small fraction of the cost of drug development studies. And our team is experienced at designing and conducting research that not only meets these stringent guidelines but also maintains budgetary goals. One of the ways our team accomplishes this is by noting key areas in which your desired research project could be modified to meet your target budget without compromising quality.
Factors influencing overall study cost:
Population of Interest
Who is the end user of your product? Studies must be applicable to your users, which means our team must recruit a highly specific study population to demonstrate your product's effects. These participants must also be individuals who are likely to respond to your product. For example, if your product is an essential oil blend, to demonstrate its effects, our team needs to locate individuals who are not already using your product. The more common your end user, the less expensive it is to recruit participants, screen them for inclusion criteria, obtain informed consent (and assent, in the case of minors), and monitor them for adherence to the protocol. Wherever possible, our team will recommend the largest possible participant population. This ensures that your overall costs are kept low and that the study's effects are generalizable to the largest group of users possible.
Study cost is determined in larger part by the sample size required to meet your objectives. Our team will conduct extensive analysis to ensure the risks of type 1 (false positives) and type 2 errors (false negatives) are minimized, supplying you with a minimum required sample size. Because a study that is underpowered (i.e. the sample size is too small) is unlikely to find evidence that a product is effective, our team has an ethical obligation both to you as our client as well as to the participants of our studies to only conduct studies that are likely to identify a positive effect.
Therefore, reductions in sample size can only be accommodated through modifications to other elements of the study. If you need a reduction in the sample size to help a study fit into your budget, our team can make methodologically-sound recommendations that allow you to meet your objectives without risking your investment on an underpowered project.
The total time from exposure to data collection plays a role in total cost as well. Studies that are looking for immediate effects (i.e. reduction in anxiety scores, reduced blood pressure) are less expensive than studies that are looking at preventing a key outcome or reducing effects of a chronic condition. Longer studies may also require larger samples, to allow for the loss to follow-up that occurs over time. If you are looking to reduce total per-subject costs for your study, our team may recommend proxy outcome measures that can shorten the duration of your trial to better fit your budget.
Clinical trials require accurate measurements of the outcome of interest. This can range from low-cost, noninvasive assessments of proxy measures of the outcome of interest to high cost and clinically invasive measures. In this case, more expensive does not typically produce a better quality study. Our team will evaluate the primary outcome of interest and determine the most accurate and cost effective way to measure your product's effects.
For dietary supplements making structure/function claims, proxy measurements are almost always the most methodologically sound process and can dramatically reduce the total cost of your study. For drug claims, our team will evaluate the potential for proxy outcomes to accurately substantiate the clinical effect of interest.
Studies that compare a product to the existing standard of care are more expensive and require more participants than studies that compare a product to a placebo. Fewer people are required to demonstrate that a drug is more effective than a placebo than the existing standard of care. For the vast majority of structure/function claims and OTC drug substantiation studies, a placebo control group is the optimal comparison, allowing our team to keep overall costs low.
For some drug applications, a comparison study to demonstrate your product's efficacy as compared to the existing standard of care (if applicable) may be required. These studies will typically be larger, phase 3 studies, for drugs nearing the NDA submission stage of development.
Meet Dr Hawkins
Dr. Hawkins brings 20 years of expertise in the integrative health field to her role as Executive Director of the Franklin School of Integrative Health Sciences and the leader of our clinical research team.
She holds a Bachelor’s Degree in Environmental Health from Union Institute and University, a Master’s Degree in Health Education & Promotion from the University of Alabama, a post-graduate certificate in epidemiology from the London School of Hygiene and Tropical Medicine, a PhD in Health Research from Middle Tennessee State University, and is completing the post-doctoral Global Scholars Research Training Program at Harvard Medical School. She also holds certifications in numerous natural health fields including aromatherapy, aromatic medicine, herbalism, childbirth education, and labor support.