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,...
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...
Scott Millard of Premier Research reviews how to best operationalize fibromyalgia clinical trials in a 2017 APS Town Hall Talk in Pittsburgh, PA.
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...
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,...
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...
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...
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...
Many orally available NSAIDs are being reformulated into topical formulations for the treatment of mild to moderate soft tissue pain. The use of topical non-steroidal anti-inflammatory drugs (NSAIDs) is the preferred method for treating mild to moderate soft tissue injuries. Reducing the systemic exposure of NSAIDs should reduce the chances of gastrointestinal (GI) and cardiovascular...
Children are not little adults, and protocols for pediatric pain studies must take into account the unique needs of children to meet regulatory and ethical standards and protect this vulnerable population from untreated pain. Sponsors of pediatric analgesia clinical trials are tasked with designing studies that are both realistic to execute and sufficiently rigorous to...