Skip to main content

Benchmarking improvements in pain management

Projects can often help each other reach their goals, as demonstrated by the IMI projects IMI-PainCare and EQIPD. Together, they are helping to bring better approaches for those suffering from acute and chronic pain.

20 July 2022
A woman is sitting on a sofa, facing towards us. She's doubled over in pain, so we can't really see her face, just the top of her head. She's wearing a white top, grey cardigan and blue jeans. Her long dark hair is tied back in a ponytail.
Image by Ahmet Misirligul via Shutterstock

Everyone would recognise pain as having a significant impact on quality of life. It can be a consequence of treatment – such as post-surgical pain – or can be a signal of other issues. Pain can also lead to secondary problems – lack of sleep, anxiety and a reduced cognitive and physical functioning; it can keep people socially isolated or unable to work.

Irrespective of the cause, managing pain better would improve the lives of huge numbers of people. This is why the IMI project IMI-PainCare has been working to improve how we approach acute or chronic pain management.

This is no simple challenge; pain – although real - is subjective, and each individual experiences it in their own way. Therefore, in order to assess whether pain management is improving requires methods of assessment that allow for valid measurements and comparisons. This needs to cover the entire drug development pipeline, from lab-based test, through the initial trials as a potential treatment in humans, to full clinical trials designed to assess how well a treatment works.

To address this challenge, PainCare works from multiple angles, for example by standardising and improving so-called ‘patient reported outcome measures’ (PROMs), where patients record the level and intensity of their experience. However, the project also needed to align this PROMs data with results from preclinical experiments, meaning that markers that can be assessed in animals were also needed. This is why IMI-PainCare turned to fellow IMI project EQIPD for assistance.

The EQIPD project ran from 2017 to 2021 and was originally established to address issues of data quality in pre-clinical research. In particular, it focused on the so-called ‘reproducibility crisis’, which refers to the phenomenon that attempts to reproduce the results of many scientific experiments do not work. This reproducibility crisis particularly affects fields with ‘soft’ or patient-reported outcomes such as pain, as they are difficult concepts to translate to animals.

EQIPD tackled this challenge by developing guidance that ensures that early drug development research - the most common time for failure - follows a structured, rigorous, transparent approach. This would ease the transition to clinical testing by establishing common guidelines for developing robust, rigorous and valid research data.

Given the particular challenges of pain research, IMI-PainCare saw that the approaches used by EQIPD could help in assess study design and data analyses, and approached them for help. In turn, this would assist IMI-PainCare in their ambition to produce reliable results that can be reproduced in both animal experiments and humans. This led to IMI-PainCare participants contributing to the ‘field-testing’ for the feasibility of the EQIPD guidance, while IMI-PainCare used a quality management system developed by EQIPD to ensure data integrity. This collaboration has already been helpful for both consortia, leading to EQIPD acknowledging the IMI-PainCare contribution in a recent scientific publication.

Vollert J, Macleod M, Dirnagl U, Kas MJ, Michel MC, Potschka H, Riedel G, Wever KE, Würbel H, Steckler T, EQIPD consortium, Rice ASC. The EQIPD (Enhancing Quality In Preclinical Data) framework for rigour in the design, conduct, analysis, and documentation of animal experiments. Nature Methods, in press

IMI-PainCare and EQIPD are supported by the Innovative Medicines Initiative, a partnership between the European Union and the European pharmaceutical industry.