Trial Design

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.

Electronic solutions such as IVR systems, PDAs, and digital pens exhibit advantages over paper and pencil in PRO data collection.

The need for new trial designs will require flexibility with regard to cost drivers.

Independent experts help reduce variability and bias in trials that use medical imaging.

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

Prof. Marion E.T. McMurdo elaborates on the importance of including older subjects in clinical trials.

Targeted designs for clinical trials are the next step in predictive diagnostics.

A clearly defined set of performance measures is an integral part of the central laboratory selection and management process.

How unwanted emails can deepen our understanding of trial probabilities.

Adequate female representation is mandatory, but gender differences should not be overestimated.

Based on the numbers, sponsors will rapidly change their clinical trials midstream.

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.

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

Will the new pediatric and ethics initiatives receive enough funding to make them truly work?

A challenge that intersects the global community