Analgesia

Clinical Research: Phase 1 - Phase 4

PharmaLive – Trends and Challenges in Fibromyalgia Drug Research

It’s hard to fault fibromyalgia patients for feeling ignored and underserved. For years, many health professionals doubted and discounted their symptoms, even labeling them as malingerers. Physicians and researchers cannot easily or directly observe fibromyalgia’s manifestations, but must rely on patient reports of pain and a range of other symptoms. What’s more, no clear biomarkers...

Clinical Research: Phase 1 - Phase 4

Premier Insight 237: That Was Easy

Regulatory Submission Filed a Full Year Ahead of Schedule 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)....

Study Design

Just How Big is the Placebo Problem?

The placebo response is a real psychological, physiological, and ultimately statistical phenomenon that can be a powerful therapeutic tool in the world of medicine, especially when it comes to chronic pain conditions. For a drug to be approved, its developers must be able to demonstrate that it is significantly more effective compared to a placebo....

Consulting

Analgesia eBook: The Placebo Problem

For hundreds of years, the medical community has known that the mere act of receiving treatment, even if it’s just a sugar pill, can improve a patient’s symptoms. Therefore, in order to ensure that the effects of an experimental treatment are real, most randomized controlled trials (RCTs) include a placebo arm. Placebos are most often...

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...

Clinical Research: Phase 1 - Phase 4

Considerations When Operationalizing Trials for Osteoarthritis of the Knee

Treating the chronic pain experienced by patients with osteoarthritis is among the most enduring challenges in analgesic drug development. Operationalizing trials for osteoarthritis of the knee requires careful consideration of study design, strategies for mitigating placebo response, and site selection. Osteoarthritis, sometimes called degenerative joint disease or degenerative arthritis, occurs when the protective cartilage on...

Consulting

The Placebo Problem, Part 15: Ethical Considerations

This is the fifteenth and final installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. As our Placebo Problem series draws to a close, we conclude by taking a brief look at three ethical issues...

Consulting

The Placebo Problem, Part 14: A Brief History of the Placebo

This is the fourteenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. The term “placebo” first took hold in an unlikely place: funerals. Placebo, Latin for “I shall please” first came into use in...

Consulting

The Placebo Problem, Part 13: The Pediatric Placebo Response

This is the thirteenth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Read the rest of the posts in the series here. Until now, our Placebo Problem series has focused exclusively on the placebo response in adults. Today we turn to another population: kids....

Clinical Research: Phase 1 - Phase 4

The Placebo Problem, Part 12: The Nocebo Response

This is the twelfth installment of our look at the increasingly high placebo response that is plaguing clinical trials in analgesia and psychiatry. Catch up on the rest of the posts in the series here. After focusing exclusively on the placebo effect in this series, today we’re going to take a quick detour, turning to...