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Tag: Fibromyalgia

Clinical Research: Phase 1 - Phase 4

Patient-Reported Outcomes in Fibromyalgia

Fibromyalgia is a chronic, complex pain condition characterized by widespread pain and a diverse range of symptomatic manifestations, including fatigue, sleep disturbance, dyscognition, diminished physical functioning, and mood disturbances. To date, patient-reported outcomes remain the best method for characterizing the many facets of fibromyalgia. Patient-reported outcomes are gaining traction as a highly effective option for...

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Clinical Research: Phase 1 - Phase 4

Six Insights To Treating Fibromyalgia

The journey to treating fibromyalgia has taken a sometimes circuitous path. After a burst of activity about a decade ago, the pursuit of new therapies took a years-long pause before reigniting in recent years. In the past five years, we’ve performed 16 fibromyalgia clinical trials (more than any other CRO), and here are some reflections...

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Consulting

Rushing Site Selection in Fibromyalgia Trials, Not a Great Idea

In the early days of fibromyalgia drug research, trial site selection centered almost exclusively on rheumatologists and pain centers. But with more drugs on the market and still more studies underway, there has been significant expansion in the number of sites equipped to conduct this research. Up to a point, anyway. As fibromyalgia therapy matures,...

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Clinical Research: Phase 1 - Phase 4

Fighting the Placebo Effect in Fibromyalgia Drug Trials

Placebo response is an ever-present threat in analgesia clinical trials, and failure to sufficiently prove the efficacy of the researched compound can easily doom your promising new product. The risk can be especially pronounced when studying drugs to treat fibromyalgia. Fibromyalgia patients can be — and don’t use the term casually or critically — needy....

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Consulting

Distinctive Characteristics of Fibromyalgia Patients

Patients in fibromyalgia clinical trials are an interesting bunch. On one hand, you’ll seldom find a more accommodating and cooperative group of people. For years the condition was so poorly understood that many patients were treated dismissively by physicians who didn’t recognize fibromyalgia as a genuine affliction. And even today, the disease’s many symptoms continue...

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Clinical Research: Phase 1 - Phase 4

In Treating Fibromyalgia, Goal Is Overall Benefit — Not Just Less Pain

The most prevalent gauge of efficacy in the study of fibromyalgia drugs is — no surprise here — pain relief. But analgesic effect alone is not a sufficient measure in the eyes of the FDA, which seeks evidence of overall benefit and improvement in patient function when evaluating treatments for a condition commonly associated with...

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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...

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