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Data Management & Biostatistics

Risk-Based Quality Management (RBQM) – A Collaborative Approach to Holistic Clinical Trial Oversight

Developing, executing, and overseeing clinical trials is a complex process. Gaining reliable evidence from clinical trials is essential for appropriate decision-making activities regarding trial participants’ safety and the reliability of trial results.  As clinical trials have become more complex, the clinical trial process has faced significant operational challenges. As a result, sponsors must identify proactive...

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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...

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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. We needed a new outreach and recruitment process, so we tried radio, outdoor, and subway. We rigorously tracked what worked...

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Clinical Research: Phase 1 - Phase 4

Premier Insight 250: A Study That Wasn’t Working Until Premier Research Stepped In

A customer called on us to rescue a study that just wasn’t going well. (It happens a lot.) The challenge was to deliver data the company needed to make a go-/no-go decision at a major internal meeting that couldn’t be rescheduled. The problems stemmed, in part, from a failure to communicate between a large, somewhat...

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Consulting

Ethical Considerations in Adaptive Design Clinical Trials

While adaptive design is associated with many potential benefits, it may also present challenges to observing the basic ethical principles of research in human subjects. In this white paper, we review the features of particular clinical trial design adaptations and discuss the ethical obstacles they can present and those they can potentially resolve. The value...

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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...

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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...

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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...

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