Via the State, a report on the difficulties in enrolling patients in the necessary clinical trials to make it to market:
Stricter eligibility criteria are making it even harder to find patients. Often only patients with a specific condition can join the pivotal phase of a trial – the largest, most important and most costly phase of a trial to show if the drug or device really works. On average, about one in 20 prospective patients alerted about a trial actually qualify for and enroll in it, McDonald said.
A decade ago, two of three patients enrolled in a trial at the suggestion of their doctor or nurse; now doctors refer about one in four. Patients are less willing to blindly follow their doctor’s advice, McDonald said.
Plus, “there are so many clinical trials, it is hard for doctors to keep them all on their radar,” said Mark Summers, chief executive of 3-Wire, a firm that helps drug and device companies recruit and retain patients in their clinical trials.
Medical devices have higher hurdles to cross, economically. The article relates the difficulties of St. Jude’s latest pacemaker/defibrillator — would you sign up for an experimental heart device trial, where there’s a 50% chance your device will be inactive (‘control group’), and there’s an FDA-approved device already on the market? No wonder they’re not meeting enrollment goals.
More from the FDA‘s Clinical Trials Guide
