Side Chat: Modern Analgesic Trials
A Q&A after PAINWeek 2019, with PPM Board Member Srinivas Nalamachu, MD, of the Mid America PolyClinic, Kansas. Dr. Srinivas led a panel on modern analgesic trials at PAINWeek 2019.
PPM: In general, how do analgesic trials differ from other more general drug trials?
Dr. Nalamachu: Primary endpoints in the clinical trials are mostly subjective with no objective evidence to measure. Multiple failed trials in the recent past have raised concerns about placebo response. Sponsors are spending more time and resources on educating the research subjects to minimize the placebo response. They are also educating research personnel to better prepare them for proper evaluation of the subjects and their responses.
PPM: As clinicians consider safety and efficacy trials in today’s healthcare context, what types of red flags should they look for?
Dr. Nalamachu: Any time you see data that is ‘too good to be true’ in terms of efficacy or safety, we as clinicians should a take a closer look at the study design and the study population.
PPM: What is one way that analgesic trials may improve?
Dr. Nalamachu: Based on the demographics of patient populations and the knowledge from animal studies that we have to date, it would be wise to encourage enrolling more female subjects in fibromyalgia and migraine studies going forward.