Unsure About Appropriate Trial Design?
All types of trials can yield valuable scientific evidence when used appropriately to test various hypotheses or to observe various food or drug effects in humans. Each clinical trial type requires specific clinical trial methods and data analysis. Randomised Clinical Trials (RCTs) can be designed to test for “superiority” (one is better than the other), “non-inferiority” (one is not worse than the other) or “equivalence” (one cannot be differentiated from the other) among other study designs.
Parallel-group, crossover, cluster, or factorial design.
Single, double, triple, quadruple blinding
Observational or interventional
Open labelled, placebo controlled, comparator controlled
Allocation of Participants
Randomized or not randomized
Clinical Trial Goal
Bioavailability, safety and tolerance, structure or function claim.
What is the Best Trial Design?
- Observational: without any planned interventional or placebo treatment; treatment is outside the control of the investigator. These studies are described as being most useful for recognizing food/drug and health associations and generating hypotheses.
- Interventional: specific treatment is carefully planned and controlled by the investigator. Studies are used to examine causation and to test hypotheses.
- Pragmatic: designed to assess treatment effectiveness in routine clinical practice conditions. They are considered low-risk because the treatments are considered standard of care in clinical practice and the results are applicable to broad populations due to the large sample size, simplistic designs and diverse settings.
- Explanatory: designed to evaluate efficacy of a treatment in a highly controlled setting, the archetypical drug trial.
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What is the Best Trial Design?
Randomised Human Clinical Trials (RCT's) are considered the gold standard of evidence for the scientific substantiation of claims by many regulatory bodies such as EFSA & FDA.
RCTs involve randomly assigning participants to two or more groups (an experimental group and a control group) and comparing the outcomes of the groups to determine the effectiveness of a treatment or intervention.
RCT's add medical knowledge & provide effectiveness of interventions for disease prevention. However, optimal trial design does not always require a randomized, double-blind, placebo-controlled trial (many types of clinical trials can yield scientifically valid results). Our team understands the difference in clinical study design and we advise our sponsors on the most suitable type for their goal.
Our Clinical Trial Process
Selecting Appropriate Comparison Groups:
- A “parallel-group” design where participants are randomly assigned into two or more groups, each receiving a different treatment or intervention. The groups are then observed and compared over a specified period to determine each treatment's effectiveness and safety.
- A “crossover” design where participants receive multiple treatments or interventions in a predetermined sequence. Each participant serves as their control, as they receive both treatments, and the effects of each treatment are compared within the same individual.
- A "dose-escalation" design where participants start on the lowest dose of study product and over the duration of the study period, they are escalated across several doses.
Our team has put together these clinical trial case studies in multiple topics to help you understand how we have assisted other sponsors in the past to tailor their clinical research programs.
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Many of our clinical studies conducted are translated to published research papers in some of the top nutrition journals. You can discover our latest published work under this section.