Zelen's design

Zelen's Design

Zelen's Design (pronounced: ZEH-len's Design) is a unique approach to clinical trial design, named after its creator, Marvin Zelen. This design is particularly used in randomized controlled trials where the consent of participants is obtained after randomization.

Etymology

The term "Zelen's Design" is named after Marvin Zelen, an American statistician who made significant contributions to the field of biostatistics and cancer research. He first proposed this design in the 1970s to address ethical issues in clinical trials.

Description

In a traditional randomized controlled trial, participants are informed about the trial and its potential risks and benefits before they are randomized to different treatment groups. In contrast, in Zelen's Design, participants are randomized first, and then those assigned to the experimental group are informed about the trial and asked for their consent. Those assigned to the control group are usually not informed about the trial and receive standard care.

Advantages and Disadvantages

Zelen's Design has several advantages. It can reduce selection bias because participants are randomized before they give consent. It can also reduce the potential for therapeutic misconception, where participants believe they are guaranteed to receive a beneficial treatment in a trial.

However, Zelen's Design also has some disadvantages. It can be seen as ethically problematic because it does not obtain informed consent from all participants before randomization. It may also lead to higher rates of refusal or dropout in the experimental group once participants are informed about the trial.

Related Terms

• Randomized Controlled Trial
• Selection Bias
• Therapeutic Misconception
• Biostatistics
• Cancer Research

External links

• Medical encyclopedia article on Zelen's design
• Wikipedia's article - Zelen's design

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