According to this article at Clinical Trials Today, trial design and regulatory consulting is experiencing a surge in Phase I of clinical trials. Most companies going to CROs are looking to make quicker decisions, and are also looking for someone to provide thought leadership.
This article focuses on Parexel, who’s conforming to the demands of the customers and moving the patient recruitment step to the first possible phase.
Michelle Middle, vice president and leader of Parexel’s worldwide pharmacology business had this to say about the change:
“Traditionally, Parexel’s phase I work focused on healthy volunteers, but we are moving more towards early drug development, which includes proof-of-concept work. We are seeing, across the board, that sponsors are seeking patient volunteers [intent-to-treat subjects] as soon as possible in phase I. We review every potential protocol we receive from a scientific point of view and suggest to sponsors, if it is necessary, different study designs.”
The efficiency of the systems must be kept up when dealing with this new way of running the trials. Timelines must be maintained, as well as the retention of healthy patients who are participating in the trial.
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