how to recognize a good clinical trial?

Clinical trials on nutraceutical products are increasingly widespread and their promotion is becoming a vital asset for achieving market success. However, not all clinical trials are created equal. What are the factors that make a trial “good”?

Consumers are becoming more educated and proactive when deciding which nutraceutical products to buy. They are increasingly paying attention to proof of efficacy. With big pharma brands stepping into nutraceuticals, the rules are shifting, and clinical substantiation’s importance is increasing rapidly even on the finished products.

How do we distinguish good clinical trials from the rest?

Which factors determine the quality of a clinical trial?

The factors that determine a good clinical trial are:

  • statistics
  • population
  • adhering to Study Standards
  • ability to replicate the study
  • following the guidelines for sharing the results

Watch the video or continue reading to find out more.

Statistics.

A good clinical trial meticulously plans its statistics in advance – from sample size to anticipated effects. This precision is crucial for obtaining results than are not only relevant but also open to a meaningful interpretation.

Principles, such as control group, double blinding, and randomization are important to establish causality, reduce the placebo effect, and reduce selection bias. Moreover, when designing a clinical trial, one should also consider maintaining the product formulation, dosage, and format for solid substantiation.

Due to fast-paced lifestyle, consumers demand more convenient delivery formats for their food supplements, so they can use them on the go.

Population.

Next, consider the chosen population. Food supplements are designed for everyday use, not for treating disease symptoms. Therefore, clinical studies on nutraceutical products should focus on individuals with a moderate deficiency or problem. The higher the deficiency, the sooner we can show a result, which can make it less relevant in terms of everyday use for consumers who suffer from a moderate deficiency.

Study standards.

Adhering to Study Standards, such as Good Clinical Practice, is crucial. Good Clinical Practice (GCP) comprises standards that a clinical study follows in its execution system and is primarily intended for the field of pharmacy. In this practice, you ensure that everything is traceable, anticipated, and documented and that you work genuinely in the best interest of those involved – safety and side effects are monitored, the product’s status is tracked, and all processes within are documented.

If you want to be able to replicate a clinical study, it is imperative you thoroughly describe every step of the process.

Thorough description.

The desire is for things to be as thoroughly described as possible. To know which methods were used in the study and to have enough general data about what happened during the study so that one can replicate the study themselves.

Sharing results.

When it comes to sharing results, it is advisable to be in line with the CONSORT guidelines for reporting the results of clinical trials. In practice, this means that when you’re preparing an article, you systematically follow the checklist and present outcomes in a clean, transparent, and complete manner. Optimal transparency and minimal risk of bias are achieved when the source of funding and independence of the research team are clearly stated.

In the end, not only the pros but also the negative aspects of the research should be highlighted.

In summary, recognizing a good clinical trial on nutraceutical products involves a blend of statistical precision, thoughtful population selection, meticulous documentation, adherence to study standards, and transparency in reporting. As the world of food supplements evolves, these criteria become the cornerstone for building trust and credibility in the eyes of both consumers and industry experts.

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