Tag: case study

Data Management & Biostatistics

Premier Insight 244: Data Management: A Growing Challenge, Made Easier

Every day, the world creates and stores 2.5 quintillion bytes of data. If you really must know, that’s 2,500,000,000,000,000,000 bytes. We’re piling it up faster than ever, too — so fast that 90 percent of the data that exists today was created in the past two years. Moving and sharing all that information is a...

Clinical Research: Phase 1 - Phase 4

Premier Insight 251: It Helps to Know What’s Going to Happen Next

No guesswork here. It’s a combination of experience and that often-overlooked scientific discipline called common sense. We were conducting a Phase 2b trial of a new treatment for nonalcoholic steatohepatitis, or NASH. And we knew three things: We knew that hepatologists would jump at the chance to enroll their patients, because the only existing treatment...

Consulting

Premier Insight 249: A High Unmet Need that No One Wanted to Talk About

What do you do when patients are too embarrassed to talk about what’s wrong with them? It was a trial for fecal incontinence, and patients wanted help – they just didn’t want to admit it. We needed a new outreach and recruitment process, so we tried radio, outdoor, and subway. We rigorously tracked what worked...

Clinical Research: Phase 1 - Phase 4

Premier Insight 236: Fibromyalgia: Gaining Knowledge of a Little-Understood Disease

Joining in the elusive pursuit of fibromyalgia pain relief, a small pharmaceutical company engaged Premier Research for a Phase 3 trial following our completion of the product’s Phase 2 research. The compound under study: a muscle relaxer on the market for decades, repurposed for the possible treatment of fibromyalgia. The sponsor chose Premier Research largely...

Patient and Stakeholder Engagement

Premier Insight 253: Is it Safe or Not? Ask a Panel of Independent Experts

When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...

Patient and Stakeholder Engagement

Premier Insight 255: Merging Science and Nuance to Treat Post-Traumatic Stress Disorder

When it comes to study data, not everything can be easily measured and reflected by numbers. In a recent trial of a new occluder device for transcatheter closure of secundum atrial septal defects, the primary efficacy endpoint of defect closure was easy to measure in millimeters of possible residual shunt. However, assessment of the safety...

Data Management & Biostatistics

Premier Insight 238: Back On Track: Data Rescue On Pediatric Rare Disease Trial

  Imagine rebuilding the engine in an ambulance carrying a critically ill patient to the hospital. Got it? Then you have a pretty good idea what it took to put this pediatric rare disease trial back on track. A pharma company developing a drug to treat urea cycle disorder struggled with a CRO that was...

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. “Hello, it’s me again.” We sent feasibility...

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 2 trial involved a CD19 antibody that was tested at 26 sites...