What is to know about adaptive randomized clinical trial design?

Adaptive design clinical trials are a controlled experiment in human volunteers that is used to evaluate the safety and efficacy of treatments or interventions against diseases and health problems of any kind. Adaptive design clinical trials also determine pharmacological, pharmacokinetic effects of new therapeutic products, including the study of their adverse reactions.

In some cases where it is desired to demonstrate that the preparation is equivalent or superior to the existing standard product, and to protect patients who need prescription medication, active monitoring should be employed.

A paradigm of epidemiological phase

Randomized controlled clinical trials are considered the paradigm of epidemiological research. They are the designs that are closest to an experiment due to the control of the conditions under study and because they can establish cause-effect relationships if the following strategies are established efficiently –

• Assignment of the intervention maneuver through randomization mechanisms in subjects with homogeneous characteristics that allow guaranteeing the comparability of populations,
• The use of a control group allows the unbiased comparison of the effects of two possible treatments, the new, and usual or placebo,
• The blinding of the treatment groups minimizes possible information biases and makes information comparability possible.

Epidemiological studies are classified

The main feature of experimental studies is that the investigator randomly assigns exposure. In relation to the temporality characteristic, these studies are prospective in nature, and due to the number of successive observations made during the study period, they are classified as longitudinal. In these studies, the units of analysis can be individual or group.

Clinical trials with various characteristics

The classical experimental design has different characteristics that define it. The first is the control of the conditions under study (the selection of the subjects, the way in which the treatment is administered, the way in which the observations are obtained, etc). The interpretation criteria must be implemented as uniformly and homogeneously as possible. The second is that there must be an intervention maneuver under study and at least one control group.

Third, study participants must be randomly assigned to intervention groups (no researcher, participating clinicians). The fourth is that the population of study subjects must be stratified into subgroups, by various factors, such as age, sex, ethnic group and severity of the clinical condition studied, to restrict the comparisons to the subjects that are part of the same subgroup. Finally, it is required that the event of interest is perfectly defined and quantified before and after receiving the intervention. It is necessary to consider that the term test is comparable in this type of experimental study.

Source: https://mamby.com/post/what-is-to-know-about-adaptive-randomized-clinical-trial-design

About This Author

Pharmaceutical Development Group https://pharmdevgroup.com/ Pharmaceutical consultant Joined: August 17th, 2020