Premier Insights

Consulting

Premier Insight 268: When Other CROs Said No, We Said Yes – to the Nearly Impossible

The client asked the nearly impossible — a task so daunting that two other CROs had simply said “no, thanks.” Completing a new drug application typically takes a year to a year and a half, but the time available here was six months. And the short timeline was only the half of it. So we...

Patient and Stakeholder Engagement

Premier Insight 242: How Ramping Up Communications Helped Overcome a Next-to- Impossible Recruitment Challenge

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.

Clinical Research: Phase 1 - Phase 4

Premier Insight 265: Complete Response: Lymphoma Trial A Surprising Success For Five Patients

A trans-Atlantic study to evaluate an antibody for treatment of B-cell non-Hodgkins lymphoma is still almost three years from completing patient follow-up, but already it has succeeded beyond expectations in the form of five patients declared disease-free a year and counting. The Phase II trial involved a CD19 antibody that was tested at 26 sites —...

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 twice its...

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 I 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...

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...

Consulting

Premier Insight 243: The Question Was a Real Puzzle – and the Answer Changed Everything

Things were complicated enough to start. The customer, conducting a Phase 2/3 dose-finding/pivotal study for an adult growth hormone drug, changed its protocol midstream in response to regulatory feedback and was rethinking other aspects of the trial, adding to its complexity. For weeks, the sponsor’s requirements changed almost daily, severely testing an incumbent lab vendor...

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.

Consulting

Premier Insight 263: The Case of the Elusive Protocol

There wasn’t any magic to our success. It was a matter of patiently adapting to changes, communicating clearly and frequently with all concerned, and maintaining our focus throughout. It also helped that we had regulatory specialists in each country to handle submissions on their home ground. As a result, we were able to balance the...

Patient and Stakeholder Engagement

Premier Insight 254: Dealing with the Unexpected: Surprisingly Fast Enrollment

Normally we’re ready for anything at Premier Research. We anticipate every contingency. This time the patients caught us off guard, by rushing to enroll almost as soon as word of the study got out. That’s because we were dealing with a significant unmet need: Most patients with Binge Eating Disorder (BED) seek help from psychiatrists,...