Analgesia

Medical and Regulatory Affairs

PharmaLive: Overcoming the Placebo Roadblock on the Path to Novel Analgesic Drug Development

Placebo response is one of the most significant challenges faced by drug developers who are investigating new pain medications. According to a review of published chronic neuropathic pain trials, placebo responses have increased in magnitude over time, making it even more difficult to definitively demonstrate treatment advantage.1 Research has also shown that up to 60...

Study Design

How to Mitigate the Placebo Response in Analgesia Clinical Trials

The placebo effect can be problematic in analgesia clinical trials with a symptom-based approach, as placebo-related analgesic responses may occur and persist for some time in up to 60 percent of study participants.1 In chronic pain studies, it is generally assumed that the placebo effect accounts for approximately 30 percent of the analgesic response.2 The...

Study Design

The Great Debate: The Use of Placebo Control in Chronic Pain Studies

The use of placebo control in clinical trials has long been a topic of spirited debate. Proponents maintain that placebo control is necessary for proving the safety and efficacy of investigational products. Critics argue that use of placebo sacrifices patient welfare and is unethical if a proven therapy is available. In analgesia studies, the question...

Data Management & Biostatistics

Establishing Risk-Based Monitoring within a Quality-Based System as ‘Best Practice’ for Clinical Studies

Risk-Based Monitoring (RBM) makes an impact. The US Food and Drug Administration (FDA) requires that clinical trial sponsors “provide oversight to ensure adequate protection of the rights, welfare, and safety of human subjects and the quality of the data submitted to FDA.” [US FDA 2019] This has traditionally been accomplished through onsite monitoring visits and...

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...

Clinical Research: Phase 1 - Phase 4

Picking Neuropathic Pain Trial Sites? Look for Experience — Among Other Things

Of all the truisms that apply to clinical drug research, probably none is more universally accepted than this one: “There’s no substitute for experience.” But if you’re working in an indication that is not widely studied, selecting sites on the basis of experience can be difficult. That’s one of many subjects we addressed in a...

Clinical Research: Phase 1 - Phase 4

The Placebo Problem in Pain Research: Keeping Up With the ‘Mrs. Joneses’

We were conducting a trial for a painful diabetic neuropathy (PDN) drug and were investigating why one site had an especially high placebo response rate. Then one of our representatives, waiting in the site’s lobby to meet with the principal investigator, pinpointed the likely reason when a patient walked in the door. “Mrs. Jones,” the...

Clinical Research: Phase 1 - Phase 4

Neuropathic Pain: What It Is, How It’s Diagnosed, How It’s Treated

Between 7 and 10 percent of the U.S. population suffers from some type of neuropathic pain, and a significant share of those affected require chronic pain treatment.[1] This high rate of occurrence makes our limited understanding of these afflictions, and the long search for effective treatments, all the more frustrating. Treating neuropathic pain starts with...

Clinical Research: Phase 1 - Phase 4

Neuropathic Pain Studies: Patient Selection, Study Design, And Clinical Trial Challenges

Treatment of neuropathic pain has been a challenge for drug developers for years. Opioids show limited efficacy and are subject to abuse. Tricyclic antidepressants, long considered first-line therapy, have been hampered by side effects and are still effective in only about one-third of patients. Treatment of neuropathic pain has been a challenge for drug developers...

Clinical Research: Phase 1 - Phase 4

Premier Voices #4: The Placebo Problem Part 2 With Michael Kuss

Measuring, interpreting, and mitigating placebo response is a persistent and growing challenge in analgesia clinical trials. In the conclusion of our Premier Voices podcast series on the placebo problem, Paul Mirek, Marketing Manager, and Michael Kuss, BS, Vice President, Analgesia Product Development, examine experimental trial designs, inclusion and exclusion criteria, and other approaches to managing the...