Clinical trials of pain and related disorders are plagued by large variability in patients’ ability to accurately report their pain; in fact, 20% to 30% of patients enrolled in a pain trial are unable to report their symptoms accurately. This leads to the patients’ inability to discriminate between effective drugs and placebo, having a detrimental impact on clinical trial outcomes.
Because of these factors, clinical trials with subjective endpoints experience a decrease in the observed effect size of the treatment and a significantly increased risk of trial failure.
Solution and Results
By implementing our APR (Accurate Pain Reporting) Training for a randomized, controlled pilot study for patients with Painful Diabetic Neuropathy (PDN), WCG Analgesic Solutions found that patients could better report their pain intensity and discriminate between active drug and placebo.
The results? Subjects who underwent APR Training had a lower placebo response than those who did not undergo training.
- WCG Analgesic Solutions used the Evoked Pain Training (EPT) method to determine whether patients could report their pain experience accurately, a method that involves mechanical stimulation of the thumbnail bed.
- The APR program demonstrated that subjects’ ability to accurately and reliably report their pain is a skill that improves upon training.
- The use of training approaches in future pain and other CNS programs has the potential to improve assay sensitivity and increase the likelihood of achieving a positive clinical trial.
1. Treister R et al., Training Subjects to report their pain more accurately improves study power: Results of a randomized placebo-controlled study of pregabalin vs placebo in PDN. IASP, Japan, 2016