About INTEGRATE Pain
History of INTEGRATE-Pain
The National Institutes of Health (NIH) in the United States, including the NIH Pain Consortium and the Helping to End Addiction Long-term (HEAL) Initiative, and the IMI-PainCare consortium of the Innovative Medicine Initiative (IMI), a public-private partnership for health between the European Union and European pharmaceutical companies, are dedicated to improving the understanding, management, and treatment of pain.
Both NIH and IMI-PainCare have common priorities in preclinical and clinical research, and collaboration between the two groups could help accelerate the discovery and development of new non-addictive treatments and improve the management of pain.
With the belief that collaboration can help lead to innovations in pain management, we established INTEGRATE-Pain, the “IMI-NIH Transatlantic Emphasis Group on Research And Translation-to-care Efforts for Pain.” In August 2020, the INTEGRATE-Pain Consortium held its inaugural meeting to discuss opportunities to advance the pain field and find areas of pain research that could benefit from cooperation. During the meeting, participants identified areas where collaboration could improve pain research and meaningfully impact the pain crisis throughout the world. These areas include standardized patient-reported outcomes (PROs), the use of biomarkers, the translation of disease models and readouts, and the standardization of reporting core outcome sets (COS). Virtual workshops during the meeting highlighted the need for consensus between the U.S. and the EU on PROs to allow for the aggregation of data related to acute pain, chronic pain, the transition from acute to chronic pain, and episodic/breakthrough pain conditions.
Since the August 2020 virtual workshops, leaders from INTEGRATE-Pain have been collaborating on a systematic literature review to identify and examine pain domain COS initiatives around the world. We will bring initiatives and stakeholders together on June 14, 2022 for a virtual meeting to discuss the results of the literature review and the possibility of launching a Delphi process for pain domains. INTEGRATE-Pain is also working on writing a paper that captures the discussions from the August 2020 meeting and explores the following areas of potential future collaboration: harmonization of common data elements (CDEs); alignment across preclinical and clinical domains of disease models, comorbidities, and pain-specific outcomes; expansion and validation of biomarkers of nociceptive signal processing; and integration of preclinical and clinical studies to enhance therapy development.
Mission of the Consortium
The goals of the INTEGRATE-Pain Consortium are knowledge-sharing, harmonization of standards, combination of infrastructures, coordination of data collection to improve the statistical power of data interpretation in future meta-analyses, and joint dissemination. The Consortium has shared the results of published research within the U.S. and European Union, discussed current projects and research ideas, and identified ways to advance the field of pain science. However, the Consortium does not discuss the creation or the development of future programs/funding announcements.
Of the opportunities and priorities that INTEGRATE-Pain has established in recent years, a current area of focus is developing a consensus on a core set of patient-reported outcomes (PROs) for pain conditions (accounting for comorbidities) because both NIH and EU pain leadership realized that they were independently working on selecting and implementing CDEs for pain. Members of INTEGRATE-Pain believe that a consensus on common PROs and Patient-Reported Outcome Measures (PROMs) in clinical trials and clinical practice would enhance the pain management field. A consensus on PROs and PROMs between the U.S. and EU would allow for the comparison of quality and meaningful data in acute and chronic pain conditions, and across diverse populations (e.g. adult and pediatric). NIH and EU leadership have therefore asked the INTEGRATE-Pain Consortium to begin working on identifying and establishing a COS that could be used in both the U.S. and E.U., and ideally utilized around the globe.
What is the NIH Pain Consortium?
The NIH Pain Consortium was created to enhance pain research and promote collaboration among the many NIH Institutes and Centers that have researchers, programs, and activities which address pain. The NIH Pain Consortium is planned, directed, and implemented by the Office of Pain Policy and Planning (OPPP) within the Office of the Director of the National Institute of Neurological Disorders and Stroke (NINDS). The Pain Consortium has several goals, such as developing a research agenda for the NIH, identifying multidisciplinary opportunities in pain research, increasing the visibility of pain research conducted by the NIH (specifically through pain advocacy and patient groups), and developing and utilizing Public-Private partnerships to pursue pain research agenda.[1]
Due to the multidisciplinary and cross-agency nature of the NIH Pain Consortium, the Pain Consortium plays an important role in advancing the priorities of the HEAL Initiative. The Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is a robust and ambitious trans-agency initiative to end the national opioid epidemic through research and scientific solutions. HEAL includes almost every NIH Institute and center, and these entities collaborate on accelerating research to address the opioid public health crisis from many angles. Specifically, HEAL funds hundreds of projects throughout the United States aimed at improving our understanding, management, and treatment of pain, while also funding research into better treatments for opioid Misuse and addiction.[2]
What is IMI-PainCare?
IMI-PainCare is an international consortium of 40 partners from academia, biotech companies, the pharmaceutical industry, pain societies, and three patient organizations. It is co-led by Professor Rolf-Detlef Treede (University of Heidelberg) and Dr. Marcel Froehlich (Grünenthal GmbH). Set within the framework of the European Innovative Medicine Initiative (IMI)[3], the largest public-private partnership for health research worldwide, it was launched on April 1, 2018, to improve the care of patients with acute or chronic pain. IMI-PainCare strives to provide a comprehensive set of novel validated tools to quantify multi-dimensional outcome parameters and predictors to enable stratification of patients for individualized treatments. Valuable tools will also be developed to evaluate the success of pain therapies in real-world clinical practice and in clinical trials, and to support drug discovery.[4][5]
*It should be noted that the activities to develop core outcome sets in pain, which are coordinated by INTEGRATE-Paine, do not receive financial contributions from industry members of IMI-PainCare.
[1] The National Institute of Health, NIH Pain Consortium. About the NIH Pain Consortium. https://www.painconsortium.nih.gov/about/about-nih-pain-consortium. Accessed January 14, 2022.
[2] National Institute of Health HEAL Initiative. The Helping to End Addiction Long-term Initiative. https://heal.nih.gov/. Accessed January 14, 2022.
[3] This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No [777500]. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The statements and opinions presented here reflect the author’s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.
[4] Innovative Medicines Initiative. Europe’s Partnership for Health. https://www.imi.europa.eu/. Accessed January 14, 2022.
[5] The project IMI-PainCare has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 777500. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation programme and the European Federation of Pharmaceutical Industries and Associations (EFPIA). The statements and opinions presented here reflect the author’s view and neither IMI nor the European Union, EFPIA, or any Associated Partners are responsible for any use that may be made of the information contained therein.