Clinical trials can be overwhelming for many in the industry as they can be complex, long, and costly. However, smaller companies can conduct small well-designed trials (open label, or pilot study for instance) to gain market ground, investor trust and revenue that allows them to progress to a larger, randomized placebo-controlled trial (clinical research gold standard) to further scale their product/brand. Here are four things to keep in mind if you’re thinking about setting up a clinical trial for your nutraceutical product.
Clinical chemistry and assessments can be a significant area of cost for a trial, especially if there are comprehensive and frequent blood analyses, diagnostic scans and/or high-cost procedures required by the protocol. Often, these are required in order to adequately demonstrate efficacy and safety, however, these assessments must be carefully selected so as to best capture the defined outcomes and not increase the study cost unnecessarily.
A well-defined study population is critical to significant and sound results, but also vital to ensure you do not encounter creeping recruitment expenses […].
Study design must not only consider research quality and integrity, but also the practical reality of the study for participants. If a study is overly burdensome for participants, compliance issues abound which can add to expenses in several ways from subject replacement to repeat analyses and impaired data quality.
Many other elements of study design contribute to budget compliance, be sure to carefully consider an appropriate trial design, study length and schedule of assessments to reduce unnecessary expenditures inherent in your design.
Recruitment tends to be taken for granted and strategy should not be the subject of an afterthought in order to remain within budget. Efficient and effective recruitment of qualified and dedicated participants will ensure that a prolonged recruitment timeline or desperate recruitment incentives – maybe both, do not significantly exceed your budget. Recruitment challenges should be expected and engaged promptly with premeditated strategy. Reactionary responses to recruitment challenges are a major and unavoidable source of the budget creep if you have not first effectively defined a wise and strategic approach in the study design phase.
Anything less than an optimally designed study may lead to protocol changes during the trial lifecycle in order to correct the initial deficiency. Not only does this affect data quality and study timeline flow, but protocol amendments also add numerous costs which, with sound design, should be entirely avoided. These costs arise from IRB re-submission fees, the re-consenting of all participants and maybe even costly logistical changes such as the adequate scheduling of required or specialized site staff.
Small details can lead to big expenses. Vendor shipment disruptions can be enough to derail the most forgiving schedule of assessments and lead to additional time and resources required for subsequent deviation or violation filings. Perhaps your research site is in a building that is typically closed on weekends or a holiday. This has never been a problem, but now a critical timepoint falls on a long weekend. Adequate foresight is needed from the trial design phase, where these details should first be considered to avoid unforeseen and costly last-minute arrangements.
dicentra’s multidisciplinary team of professionals is ready to assist you in any or all phases of your nutraceutical clinical research portfolios with an optimized and transparent approach to foster your research success. Contact us to discover customized services from protocol review, monitoring, and ICH-GCP auditing, to full-service CRO execution of your research.