Types of clinical trials

Unsure about the 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 analyses. 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.

Types of clinical trials
TYPES OF CLINICAL TRIALS

Study design types

Trial design

Parallel-group, crossover, cluster, or factorial design.

Blinding method

Single, double, triple, quadruple blinding

Treatment

Observational or interventional

Comparation

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’s 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. 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.

Trial design types

  • A “parallel-group” design where participants are randomly assigned to receive either the intervention or placebo.
  • A “crossover” design where participants are randomly assigned to receive either the intervention and later the placebo or the placebo and later the intervention.
  • A “cluster” design where pre-existing groups of participants are randomly assigned to receive an intervention or placebo.
  • A “factorial” design where participants are randomly assigned to receive a particular combination of interventions or placebos.
  • 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.
Types of clinical trials

Clinical study types

  • 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.
Our Process

Our Clinical Trial Process

01.

Clinical Design

Study design is a significant phase of any clinical research project. At Atlantia we can plan and guide you to design a successful trial depending on your focus: to increase sales, to obtain a health claim or as a proof of efficacy.

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02.

Trial Regulation

Our regulatory services include ethical submissions and approvals as well as regulatory compliance with global health agencies.

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03.

Study Recruitment

Atlantia offers a proven ability to meet recruitment milestones of healthy, pre-diseased and diseased participants. We have access to populations of all age groups and we are experienced in recruiting populations from 20 to 600 participants per trial on budget, and on time.

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04.

Study Conduct

Our unique model maximises control, reduces the risk of data inconsistency, and brings a sense of assurance to our clients dealing with one competent organisation as opposed multiple contract research organisations.

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05.

Trial analysis

At Atlantia your clinical data is at the centre of our service. When the samples are collected either during study visits or remotely they are prepared and stored at our facilities at -80*c, -20*C or refrigerated temperature and analysed by our research partners.

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06.

Study reporting

The Atlantia Clinical Research team provides a comprehensive study reporting service. Our statisticians adhere to ICH-GCP standards to produce a statistical study report, and if the client requests, a full clinical study report.

Get in touch!

Our team can guide you. Schedule a meeting with our research experts to discuss your clinical research program today.

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CLINICAL TRIAL Case studies

The results speak for themselves

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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