Tag: analgesia

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....

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...

Clinical Research: Phase 1 - Phase 4

Wearable Wrist Sensors Enable Detection of Stress, Seizures, and Pain

Wearable medical devices are yielding increasingly important insights into health. Rosalind Picard, Sc.D., professor of Media Arts and Sciences at MIT, discussed the applications of one such device, wearable wrist sensors that measure electrical changes in the skin, in an informative plenary lecture we attended at the American Pain Society’s 36th annual meeting in Pittsburgh,...

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...

Clinical Research: Phase 1 - Phase 4

10 Best Practice Recommendations for Short-Duration Acute Pain Management Trials

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) is a major group providing guidance for design considerations of acute pain clinical trials. IMMPACT is made up of a team consisting of some of the most respected researchers and clinicians in the field of pain medicine. As of 2016, IMMPACT recommends these ten best practices...

Clinical Research: Phase 1 - Phase 4

Top 5 Study Design Considerations for Acute Pain Management Trials

Short-duration acute pain management trials involve a variety of complex factors that must be taken into account for successfully evaluating the safety and efficacy of a new analgesic product. These five considerations are key. 1. Choosing the Right Model There are a number of established pain models for clinical research, each with its own type, intensity,...

Clinical Research: Phase 1 - Phase 4

Designing Early Stage Studies in Acute Pain Research

When it comes to analgesic drug development, it’s important to optimize design of early phase trials. The main objectives of studies at this stage are to: Explore a range of doses Obtain data on onset, peak effect, and duration Assess relative efficacy in comparison to established analgesics To accurately evaluate their product, sponsors need to...

Clinical Research: Phase 1 - Phase 4

The Top 7 Considerations to Take When Designing Pediatric Analgesia Trials

Children aren’t little adults: Pediatric populations have needs and physiological factors that set them apart from adults. However, it’s taken time for that philosophy to catch on within the clinical research community at large. When writing protocols for trials of acute pain in pediatric populations, researchers must take these unique needs of children into account to meet regulatory...

Clinical Research: Phase 1 - Phase 4

The Why, What, and How of the Current State of CNS Drug Development

Central nervous system (CNS) disorders are a diverse group of conditions that include psychiatric, neurological and substance abuse disorders. Unfortunately for patients, treatment options for CNS disorders are often limited (or non-existent). To make matters worse, comparatively few CNS drugs are in the development pipeline. What aspects of CNS disorders contribute to lagging drug development? Read on to...