Our customer was racing to beat a competitor to registration. One critical part of the timeline: Last patient out to database lock in two weeks. In sister studies that involved 800 patients at 90 sites. And several primary investigators who were heading off on vacation just when we needed their sign-offs on the data. We...
The assignment sounded simple enough: Recruit 24 patients for a Phase 1 proof-of-concept study of inflammatory bowel disease. The first CRO that received the assignment showed how difficult it really was: They were able to recruit only nine patients in a year and a half. At that point, the sponsor asked Premier Research to step...
For a fertility study, we needed to recruit young women who had had at least three unexplained miscarriagesand who were currently trying to conceive. The field of prospective recruits was huge: all women 18 to 37 years old living in the United Kingdom. The challenge: cost-effectively reach, screen, and randomize 150 patients. The solution: motivate...
A customer asked us to do a chart review of patients with hypophosphatasia, an extremely rare metabolic bone disease with a live birth incidence of about one in 100,000. The perinatal variant is rapidly fatal. A proliferation of protocols Initially informed consent was required if local regulatory authorities and/or IRBs required it. Then the Premier...
A three-nation study of a treatment for recurring glioblastoma showed the therapy more than five times as effective as the typical protocol, an unexpectedly large advance in fighting these aggressive brain tumors. But it was a long road, and the drug’s efficacy was a big factor in extending the trial to five years — nearly...
When a developer of a CD19-directed cytolytic antibody for B-cell Lymphoma engaged Premier Research to assist with screening and enrollment in a global Phase 2 study, the Premier project team devised an operational strategy with a goal to exceed expectations. Despite several challenges, the enrollment was completed three months ahead of schedule thanks to consistent...
We knew going in that it could be the perfect recruiting nightmare. We were looking for children ages 2 to 12 for a dermatology study that involved long visits and extensive blood draws. We had extremely complex inclusion/exclusion criteria. And most parents wanted nothing to do with it. “Hello, it’s me again.” We sent feasibility...