On 30 June, 2015, new pregnancy labeling rules for prescription drugs took effect, marking the...
The value of adaptive clinical trial consulting and pharmaceutical consulting is highly correlated with up-to-date knowledge of the state of adaptive trial design.
Assignments such as writing clinical protocols and oversight of CROs have become increasingly complex as adaptive design has gained in acceptance.
In most basic terms, adaptive trials are those in which a review of interim data drives modifications to trial and/or statistical procedures, including variables such as dosage, sample size, studied compound and participant selection criteria.
Potential success of a drug or device development effort, rapidity of approval, and better outcomes for clinical trial participants may be increased through adaptive clinical trial design.
However, the increase in variables to consider at the outset, including clinical, statistical and regulatory concerns represent challenges previously not faced by many sponsors or CROs.
It is for these reasons that early selection of the right clinical trial consultant is a critical consideration.
A consultant is needed with access to statisticians, scientists, clinicians and regulatory professionals who have experienced increased operational demands of execution, monitoring and modification of adaptive clinical trials, including sourcing and oversight of CROs.
To learn about the background and current state of adaptive clinical trial design, please download Charles Jaap’s latest white paper Clinical Trial Consulting, Pharmaceutical Consulting and Adaptive Clinical Trial Design.
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The US Food and Drug Administration (FDA) would like to accelerate the over-the-counter (OTC) review...