Trial Design

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Applied Clinical Trials

Open-label extension (OLE) studies are common, but they do not receive as much attention as traditional Phase I through Phase IV studies. Enrollment into an OLE study typically follows enrollment into a randomized, blinded, well-controlled main study. Participants are usually informed at the time they are recruited into the main study that they may elect to enroll in an OLE study after completing the main trial. The stated objective of most OLE studies is to obtain long-term safety and tolerability data.

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Applied Clinical Trials

The use of composite endpoints are being regarded as a useful strategy, but caution must be applied as there are both risks and benefits.

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Applied Clinical Trials

How unwanted emails can deepen our understanding of trial probabilities.

Applied Clinical Trials

Oncology clinical trials are complex and require a different approach than trials in many other therapeutic areas. Patient recruitment is among the most challenging obstacles-especially in the United States, where oncology trials have notoriously low participation rates among adult patients. While more than 1.2 million Americans will be newly diagnosed with cancer this year, participation in oncology trials remains very low.

Applied Clinical Trials

Technology enables advances in trial design, but it is the creativity of people that really moves things forward.