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IRB Review of Adaptive Design Studies

The popularity of adaptive design in clinical research continues to grow. Adaptive design can be more efficient than traditional study design, and it can help speed decision making. Considering these benefits, plus the ever-increasing cost of conducting clinical research, it’s no wonder adaptive design is so appealing to researchers.

Adaptive design may involve changes to study eligibility, treatment arms and regimens (like dosage and duration), randomization procedures, schedule of events, primary and/or secondary endpoints, and other elements of a study all on an on-going basis. Consider the following characteristics of good adaptive design:

IRBs that continuously review changes in research can certainly understand the need for innovative approaches like adaptive design. When reviewing a study that incorporates adaptive design, an IRB will need to pay particular attention to the study’s scientific validity, subject safety, informed consents, and the research site’s qualifications. One problematic area is that the risks for subjects may well change when the design of the study changes. For each of these elements, I’ve assembled typical questions an IRB may ask during review. These may also be useful for researchers to consider as they develop adaptive design studies.

Scientific Validity

Subject Safety

Informed Consent

In addition to standard requirements, IRBs will also consider how the informed consent form (ICF) addresses the following:

Bear in mind that describing the expected changing nature of the research in the ICF can be challenging.

Research Site Qualifications


Adaptive study design can be a smart and effective strategy that offers many benefits. When developing a study with adaptive design, be sure to pay close attention to these added complexities to help ensure participants are appropriately informed and protected.

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