■ General Assembly 2021 ■
On the 2nd to 4th March 2021, the IMI-PainCare consortium held its annual General Assembly, conducted as a virtual meeting owed to the Covid-19 pandemic. About half way into the funding period, more than 70 consortium members together with IMI scientific officer Elisabetta Vaudano, the external ethics and scientific advisors, discussed exciting achievements and ongoing activities.
IMI-PainCare is actively exploring value creation opportunities, of which three are listed in the Innovation Radar Platform of the EU: https://www.innoradar.eu/resultbykeyword/imi-paincare
- Use (subjective) PROMPT results and (objective) activity measurement to calculate reliable pain, sleep and activity prediction models.
- Novel electric and mechanical stimulators as objective pain response biomarkers for supporting translational pain research and pain mechanism diagnostics.
- A New Method to Study Ongoing Pain in Preclinical Models of Endometriosis-associated Pelvic Pain.
Exciting new data and overall great progress were presented by the subproject teams PROMPT, BioPain and TRiPP, which led to several publications: see here
During their break-out sessions, the subprojects had fruitful in-depth discussions related to their specific topic.
Subproject PROMPT:Systematic literature researches on PROMs in acute and chronic pain were done; two papers are already published (additionally to a paper on the results of the first consensus meeting which was recently published in the highest-ranked pain journal), several manuscripts are close to submission or under review.
Although a bit delayed due to the coronavirus pandemic, the large prospective data collection in PROMPT, which will provide data for identifying the PROMs that work best for post-op pain management assessment and for prediction of chronification risks, is running successfully. 18 hospitals across Europe have already included 50 % of the envisaged 4,000 patients. Moreover, physical activity data from more than 200 patient, obtained with a wearable activity tracker device, could be collected. Results from this study, combined with data from industry studies and the literature researches, will lead to providing a standardized, consented tool for pain-related patient-reported outcome measurement; see here
Subproject BioPain reviewed results of preclinical studies on the effects of three model pharmacological probes (lacosamide, pregabalin, tapentadol) on biomarkers of peripheral nerve excitability (threshold tracking) and cortical nociceptive signal processing (laser evoked potentials; with auditory evoked potentials and ongoing EEG as controls). Pharmacokinetic modelling successfully predicted exposure levels in nerve and brain from plasma concentrations, and revealed meaningful differences between pharmacological probes with respect to peak tissue levels and time to peak. These pharmacokinetic models will be applied to analyse data from the RCTs in human subjects that use identical biomarkers. These RCTs have started recruitment in summer 2020 and will be completed by end of summer 2021. Thus, BioPain is on track to validate a set of fully translatable biomarkers of nociceptive signal processing for the juncture of preclinical to clinical studies; some of these biomarkers may also be useful in phase II clinical trials; see here
Subproject TRiPP: The TRiPP clinical cohort of almost 800 women now has full baseline questionnaire and proteomic and metabolomic data available and analysis of these data is ongoing. Preclinical models have been characterised and the system for assessing ongoing pain is established. Our conversations therefore focused on planning and prioritizing analysis of the clinical data to begin to back-translate these findings into the preclinical models; see here
The participating patient organisations International Painful Bladder Foundation (IPBF), Pelvic Pain Support Network (PPSN), and Endometriosis.org Ltd (EOL), also member of IMI-PainCare, directly contributed to research design and publications, and thus provided considerable benefit to scientific research of all sub-projects.
“I would first like to thank everyone in the IMI-PainCare Team for giving the patient representatives every opportunity to be so closely involved in this project. It has been a unique experience, “ Jane Meijlink from IPBF stated. “When we started, there was no real guideline available for patient engagement, so we all had to invent it as we went along. My impression is that it has worked extremely well and can serve as an example for future studies and successful patient participation.“