Update on the progress of IMI-PainCare, a public-private partnership supported by the European Union to improve the care of patients with acute or chronic pain. EFIC is one of about 40 partners of this consortium (www.imi-paincare.eu):
We are now entering the final stages of the project, with the consortium and EFIC in particular, disseminating the outcome of project to various key audiences. The outcome of the project is summarized below:
- Conducting a thorough literature review and consensus process including relevant stakeholders like patients, pain specialists, anesthesiologists, surgeons, psychologists, agencies, and nurses the following outcome domains were identified: physical function, different aspects of pain intensity, adverse events/side effects, and self-efficacy (how confident or empowered a person feels to self-manage their pain). Other important outcome domains include emotional distress, pain quality (e.g., burning, shock-like), acceptance of pain, expectation of pain, and emotional function. Unfortunately, clinical trials do not consistently measure these domains. The team identified PROs that can be used to measure these domains and used them in a huge non-interventional trial in different surgical procedures to test their sensitivity to change after the surgeries. Data on follow-up of the patients in the NIT for 6 months will be used to analyse risk factors for chronification.
- Using wearable devices to assess outcomes (e.g., activity levels) in people with pain is acceptable and feasible and may represent a scalable way to collect a comprehensive dataset for patients with pain.
- Several outcomes (e.g., emotional function) can predict a patient’s positive or negative response to various treatments, highlighting the importance of their accurate measurement.
- Five human surrogate models were found to reliably mimic pathological pain in humans, responding to pain drugs and not responding to placebos, including ones that worked in animals but failed in patients.
- Three substances (lacosamide, pregabalin and tapentadol) with different modes of action were found to identify and validate biomarkers of pain pathways at multiple levels of the nervous system.
- Two devices were developed and received CE certification for biomarker assessment in healthy volunteers.
- Patients with chronic pelvic pain have a low quality of life, and more interventions are required to specifically target this outcome. Painful intercourse is a major issue among women with chronic pelvic pain but is under researched. Significant differences were discovered between patients with endometriosis- and bladder associated pain suggesting the need for better patient stratification in future clinical studies.
The consortium is working to inform key audiences, such as regulators, politicians, research-funders, patients and others, on how these results will benefit pain science and benefit patients.
EFIC have supported these activities through the creation of information packs and outreach to various targets. The first crucial target was Members of the European Parliament. The consortium met with Member of the European Parliament Cristian Silviu Busoi at his Parliamentary office in Brussels. Mr Busoi is the influential chair of the Industry, Technology and Research Committee (ITRE), and has had a substantial impact on European research policy over the past 15 years. Mr Busoi agreed to work with the consortium to organise an event in the European Parliament on the future of pain research. This event will take place on the 21st March between 11:00 and 13:00. EFIC will shortly launch a registration process for anyone wishing to attend. The event will be co-chaired by MEP Alex Agius Saliba and EFIC are reaching out to other MEPs over the coming weeks.
In addition, EFIC organised a webinar on IMI-PainCare in January for the pain science community. A second webinar for patients interested in pain research will take place on the 6th March. You can find more information here.