Opening any clinical trial requires the satisfaction of many regulatory requirements for very good reasons. Scores of people review applications, confer in committees, weigh risks and benefits, all to make sure that the investigator has patient safety as their guide. This process is important, but it can also be lengthy and overlong delays can doom a trial before it can even begin recruiting. This is especially perilous for Phase I clinical Trials, which can face higher regulatory and coordination burdens than Phase II or III trials.
For the last year, under the direction of medical oncologist Yousef Zakharia, MD, a Phase I clinical trial working group has sought to avoid those early collapses.