Things to Keep in Mind While Conducting a Dietary Supplement Clinical Trial
Successfully conducting a clinical trial of dietary or food supplements from beginning to end can be a daunting task.
It takes leadership, good communication and committed employees to ensure a clinical program is executed promptly and with a high degree of quality and precision.
To achieve project goals; it is essential to communicate all expectations during the initial stages and foster a sense of understanding and partnership throughout the trial.
Several risks must be managed along the way and thus, understanding what risks may arise, and timing of these risks is crucial in proactively managing any clinical trial.
At Enovate Biolife, we believe that preparing for the unexpected provides a pathway to success. And we keep this in mind while conducting dietary supplement trials.
Read ahead to know more about what to expect while conducting a clinical trial for your product.
Clinical Milestones While Conducting a Dietary Supplement Trial
If you’re working with a contract research organization (CRO) to conduct a clinical trial, the first step usually involves a proposal request from your end.
A good proposal is detailed, transparent and provides full visibility on what is included or excluded from the cost.
After determining the objectives of the study, endpoints, duration and estimated number of subjects, the CRO will provide you with a proposal. Once the proposal is accepted, a clinical trial agreement is drafted and reviewed by both organizations’ legal teams.
As soon as this agreement is signed, the project can commence.
The Start-Up Phase
During the start-up phase, high-level planning and arrangement take place. This labour-intensive period is time-consuming as it involves writing, reviewing and approving numerous documents.
As time passes, the protocol is written and set in stone, site selection is undertaken, and ethics and other regulatory submissions are completed. Even though mitigating risks may seem unnecessary and time-consuming, it is a critical task that must be handled effectively.
Site selection is a vital step in the start-up period. Choosing the right site for your clinical trial requires careful consideration of timelines and budgets. Ask yourself the following questions.
- Will it be a single-centre or multi-centre study?
- What are the subject population inclusion/exclusion criteria?
- How many subjects are needed?
Study start-up goes on for an average of three months. If the study is conducted in the US and is food-based, two weeks to one month is usually required for ethics approval.
The Study Period
Site initiation is the green light for the study to begin screening subjects. Getting the study up and running starts with visiting the site, ensuring the product is present at the site and making sure all approvals are in place before initiation.
Subject recruitment often causes delays in conducting clinical trials. Most organizations fail to find fit individuals to participate in the trial. The recruitment process typically takes some time to gain traction. Therefore, early recruitment is slower than in the later stages.
It is also essential to keep in mind that only a tiny subset of the adult population may be willing to take part in clinical trials. Even fewer will meet the enrollment criteria. It is vital that your CRO or clinical research partner effectively manages recruitment so that the study can be executed with safety and efficacy.
During the study period, subjects are screened, eligible subjects are chosen, and subject visits begin. Not all subjects may complete a study, and withdrawals can occur for a variety of reasons. At this point, research teams should communicate effectively, provide good customer service and achieve quality care help to ensure subject compliance and retention.
Additional factors include having a protocol that is easy to comply with, as well as fair compensation for subjects. Recruitment continues until the last subject’s last visit has occurred, at which time the study monitor will conduct a close-out visit at the site.
This is the official end of the study period. Data entry and monitoring are ongoing throughout this phase.
The Project End
Once all the data is entered, reviewed and checked, the database can be locked. This usually happens within days of the close-out visit. The locked database is then transferred to a statistician for analysis, and the final report is produced.
This review process can vary depending on the CRO and sponsor’s review timelines. Generally, finalising statistical output takes 6-8 weeks, followed by a period of 8-12 weeks to write and edit the report.
Anticipating Potential Risks That Could Delay the Trial Results
Several facts could lead to a delay in a dietary ingredient clinical trial. Some are controllable, while others are due to third-party vendors or regulatory agency delays that cannot be controlled.
The most common reasons for clinical trial delays include:
- High turnaround time for writing, reviewing and editing start-up documents
- The product being studied is not available
- Delayed review of regulatory or ethics documentation
- Recruitment problems
- Trial test delays (if biological endpoints are included in the study)
- Data entry and clean-up taking longer than anticipated
- Statistical analysis delays or changes
- Writing, reviewing and editing the final report
- Project scope changes
Knowing the potential issues that could arise and having strategies in place to combat them is crucial in overcoming these hurdles effectively.
Achieving Clinical Trial Objectives
Clinical trials involve several moving parts. Planning and executing a clinical trial that achieves all project goals requires strong management skills and strategic oversight.
Above all, balancing the scope, costs, and timelines is essential to ensure high-quality results and critical conclusions to substantiate your product claims with confidence.
At Enovate Biolife, our proprietary ingredients are 100% US FDA-GCP compliant and have clinical studies published in reputed international journals. To learn more about the clinical studies conducted by us, visit: Quality Assurance