Tag: case study

Clinical Research: Phase 1 - Phase 4

Premier Insight 258: Glioblastoma Drug Study Yields ‘Unexpectedly Huge’ Advance

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...

Consulting

Premier Insight 235: It’s About How the Social System Works, Not Just the Science

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...

Patient and Stakeholder Engagement

Premier Insight 269: Recruitment in Reverse: Motivating Patients to Find the Study

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...

Consulting

Premier Insight 263: The Case of the Elusive Protocol

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...

Data Management & Biostatistics

Premier Insight 240: Getting Every Detail Right – With No Time to Think About How

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 256: A Talent for Resolving Unusually Complex Issues

A customer came to us with a seven-year project to develop a novel human antibody from scratch, to treat multiple myeloma. There were no benchmarks, no relevant data on similar compounds because there were no similar compounds. The first challenge: engage key opinion leaders This project was never going to be easy or “by the...

Consulting

Premier Insight 259: In Clinical Trials, Success Isn’t Always Where You Expect It

When does a clinical trial that falls short of its goal still constitute success? When the experience reveals invaluable lessons in how to avoid a repeat performance — and identifies a highly productive location for siting future studies. A large, multinational study of a drug to control inflammation in patients with recurring high-grade malignant glioma...