European Journal of Clinical

Types of clinical trials design study

Currently, some Phase II and most Phase III drug trials are designed as randomized, double blind, and placebo-controlled.

Randomized A randomized controlled trial is the study design that can provide the most compelling evidence that the study treatment causes the expected effect on human health. Each study subject is randomly assigned to receive either the study treatment or a placebo.

Blind The subjects involved in the study do not know which study treatment they receive. If the study is double-blind, the researchers also do not know which treatment is being given to any given subject. This 'blinding' is to prevent biases, since if a physician knew which patient was getting the study treatment and which patient was getting the placebo, he/she might be tempted to give the (presumably helpful) study drug to a patient who could more easily benefit from it. In addition, a physician might give extra care to only the patients who receive the placebos to compensate for their ineffectiveness. A form of double-blind study called a "double-dummy" design allows additional insurance against bias or placebo effect. In this kind of study, all patients are given both placebo and active doses in alternating periods of time during the study.

Placebo-controlled The use of a placebo allows the researchers to isolate the effect of the study treatment. A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical trials, experimental treatments are often compared with placebos to assess the experimental treatment's effectiveness. In some studies, the participants in the control group will receive a placebo instead of an active drug or experimental treatment.

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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Vaccines to prevent HPV infection and to treat several types of cancer are being studied in clinical trials.

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