Monica Simeoni, PhD: No relevant disclosure to display
Drug development in chronic pain has been challenging, with a low probability of approval by regulatory authorities for novel analgesics after completion of phase 1, if compared to other novel drugs across all diseases. The improvement of study design could be one tool to increase the probability of success either generating proprietary data with innovative trials (e.g. umbrella, basket, platform) or leveraging cross-indications / mechanisms / treatment external data to better inform more traditional designs. In this session we will illustrate a MBMA conducted across different pain types, such as musculoskeletal pain (i.e. osteoarthritis and chronic low back pain), and neuropathic pain (i.e. diabetic peripheral neuropathic pain and post herpetic pain). The analysis aimed to answer different questions to optimize the development in different pain indications, such as bridging primary endpoint in phase 2b with registrational endpoint, bridging relative effects within neuropathic pain indications as well as within musculoskeletal pain indications to support phase 3 strategy. This holistic approach to chronic pain indications (e.g. considering dose response, time course, covariate, effect size, efficacy/safety/drop out relationship) was a great MIDD example which triggered constructive cross-functional discussions and facilitated decision making.
.jpg "Monica Simeoni, PhD (she/her/hers) photo")