Tag: case study

Data Management & Biostatistics

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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.

Functional Service Provider (FSP)

Premier Insight 248: Outsourcing: You’re Now Free to Do What You Do Best

Pharma, biotech, and medical device companies are increasingly turning to contract research organizations to outsource a wide range of activities through functional service provider (FSP) arrangements. FSPs increase agility and drive down costs while offering cafeteria-style flexibility — giving clients wide latitude in choosing which services to farm out and which to keep in house.

Clinical Research: Phase 1 - Phase 4

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

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 for NASH is the well-known lose weight – eat healthy – exercise more regime. This was...

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 miscarriages and 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:...

Patient and Stakeholder Engagement

Premier Insight 270: A Rosacea Trial Failed Many Enrollment Hurdles.

Two large, parallel trials with 107 sites spread across the United States. Heavy competition for patients because of multiple competing treatments already on the market. And an advertising strategy that needed to attract more than 1,400 subjects fast enough to meet the sponsor’s aggressive schedule. Those were just some of the challenges we faced when...

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...

Clinical Research: Phase 1 - Phase 4

Premier Insight 267: From KOLs to Patient Advocates, Using Every Tool to Fight a Rare Disease

The indication: a basal cell carcinoma known as Gorlin syndrome, a disease that manifests itself in large numbers of benign tumors that grow on various parts of the body. The sponsor: a very small, virtual company consisting of a handful of contractors pursuing success in the form of a topical gel, which had only ever...

Clinical Research: Phase 1 - Phase 4

Premier Insight 237: That Was Easy

This case is a story with no drama. No sudden crisis. No last-minute rescues. It’s about a clinical trial that ran perfectly from start to finish. And that in itself is a story worth telling. The sponsor needed to test a new nonsteroidal anti-inflammatory drug (NSAID). They had worked with Premier Research before, and knew...

Consulting

Premier Insight 271: Enrolling Sickle Cell Patients Is Tough – So We Got Busy

Kick off a study of a drug to treat sickle cell disease and you’re facing a tough climb. Experimental drugs for sickle cell are few and far between, so there is little in the way of clinical trial infrastructure. The patient population is demographically challenging, too, made up largely of socioeconomically disadvantaged people who find...