Benefit–risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations

Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Rese...

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Published in:	Pain (Amsterdam) Vol. 163; no. 6; pp. 1006 - 1018
Main Authors:	Kleykamp, Bethea A., Dworkin, Robert H., Turk, Dennis C., Bhagwagar, Zubin, Cowan, Penney, Eccleston, Christopher, Ellenberg, Susan S., Evans, Scott R., Farrar, John T., Freeman, Roy L., Garrison, Louis P., Gewandter, Jennifer S., Goli, Veeraindar, Iyengar, Smriti, Jadad, Alejandro R., Jensen, Mark P., Junor, Roderick, Katz, Nathaniel P., Kesslak, J. Patrick, Kopecky, Ernest A., Lissin, Dmitri, Markman, John D., McDermott, Michael P., Mease, Philip J., O'Connor, Alec B., Patel, Kushang V., Raja, Srinivasa N., Rowbotham, Michael C., Sampaio, Cristina, Singh, Jasvinder A., Steigerwald, Ilona, Strand, Vibeke, Tive, Leslie A., Tobias, Jeffrey, Wasan, Ajay D., Wilson, Hilary D.
Format:	Journal Article
Language:	English
Published:	United States Wolters Kluwer 01-06-2022
Subjects:	Chronic Pain - diagnosis Chronic Pain - therapy Humans Outcome Assessment, Health Care Pain Measurement - methods Risk Assessment
Online Access:	Get full text
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Abstract	Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Researchers and regulators have developed a variety of benefit-risk composite metrics, although the extent to which these methods apply to randomized clinical trials (RCTs) of chronic pain has not been evaluated in the published literature. This article was motivated by an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting and is based on the expert opinion of those who attended. In addition, a review of the benefit-risk assessment tools used in published chronic pain RCTs or highlighted by key professional organizations (ie, Cochrane, European Medicines Agency, Outcome Measures in Rheumatology, and U.S. Food and Drug Administration) was completed. Overall, the review found that benefit-risk metrics are not commonly used in RCTs of chronic pain despite the availability of published methods. A primary recommendation is that composite metrics of benefit-risk should be combined at the level of the individual patient, when possible, in addition to the benefit-risk assessment at the treatment group level. Both levels of analysis (individual and group) can provide valuable insights into the relationship between benefits and risks associated with specific treatments across different patient subpopulations. The systematic assessment of benefit-risk in clinical trials has the potential to enhance the clinical meaningfulness of RCT results.
AbstractList	ABSTRACTChronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Researchers and regulators have developed a variety of benefit-risk composite metrics, although the extent to which these methods apply to randomized clinical trials (RCTs) of chronic pain has not been evaluated in the published literature. This article was motivated by an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting and is based on the expert opinion of those who attended. In addition, a review of the benefit-risk assessment tools used in published chronic pain RCTs or highlighted by key professional organizations (ie, Cochrane, European Medicines Agency, Outcome Measures in Rheumatology, and U.S. Food and Drug Administration) was completed. Overall, the review found that benefit-risk metrics are not commonly used in RCTs of chronic pain despite the availability of published methods. A primary recommendation is that composite metrics of benefit-risk should be combined at the level of the individual patient, when possible, in addition to the benefit-risk assessment at the treatment group level. Both levels of analysis (individual and group) can provide valuable insights into the relationship between benefits and risks associated with specific treatments across different patient subpopulations. The systematic assessment of benefit-risk in clinical trials has the potential to enhance the clinical meaningfulness of RCT results. Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite metric that accounts for benefit and risk in relation to each other can provide valuable insights into the effects of different treatments. Researchers and regulators have developed a variety of benefit–risk composite metrics, although the extent to which these methods apply to randomized clinical trials (RCTs) of chronic pain has not been evaluated in the published literature. This article was motivated by an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials consensus meeting and is based on the expert opinion of those who attended. In addition, a review of the benefit–risk assessment tools used in published chronic pain RCTs or highlighted by key professional organizations (ie, Cochrane, European Medicines Agency, Outcome Measures in Rheumatology, and U.S. Food and Drug Administration) was completed. Overall, the review found that benefit–risk metrics are not commonly used in RCTs of chronic pain despite the availability of published methods. A primary recommendation is that composite metrics of benefit–risk should be combined at the level of the individual patient, when possible, in addition to the benefit–risk assessment at the treatment group level. Both levels of analysis (individual and group) can provide valuable insights into the relationship between benefits and risks associated with specific treatments across different patient subpopulations. The systematic assessment of benefit–risk in clinical trials has the potential to enhance the clinical meaningfulness of RCT results.
Author	Garrison, Louis P. Jadad, Alejandro R. Dworkin, Robert H. Bhagwagar, Zubin Cowan, Penney Evans, Scott R. Junor, Roderick Rowbotham, Michael C. Iyengar, Smriti Ellenberg, Susan S. Farrar, John T. Goli, Veeraindar Strand, Vibeke Kesslak, J. Patrick Tobias, Jeffrey Kleykamp, Bethea A. Katz, Nathaniel P. Jensen, Mark P. Tive, Leslie A. Wilson, Hilary D. Raja, Srinivasa N. Turk, Dennis C. Mease, Philip J. O'Connor, Alec B. Wasan, Ajay D. Freeman, Roy L. Markman, John D. Steigerwald, Ilona Patel, Kushang V. Gewandter, Jennifer S. Kopecky, Ernest A. Singh, Jasvinder A. Eccleston, Christopher Sampaio, Cristina McDermott, Michael P. Lissin, Dmitri
AuthorAffiliation	Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD, United States Clinical Pharmacology Lab, Faculdade de Medicina de Lisboa, University Lisbon, Lisbon, Portugal Chief Medical Officer SVP Neumentum, Inc, Morristown NJ, United States Department of Psychiatry, Yale School of Medicine, CT, United States Division of Translational Research, NINDS, NIH, Rockville, MD, United States Pfizer, Inc, New York, NY, United States. Dr. Goli is now with the Emeritus Professor, Duke University School of Medicine, Durham, NC, United States American Chronic Pain Association, Rocklin, CA, United States Department of Neurosurgery, University of Rochester Medical Center, Rochester, NY, United States Departments of Anesthesiology & Perioperative Medicine, and Psychiatry, University of Pittsburgh School of Medicine, United States Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, United States Patient Affairs and Engagement, Boehringer Ingelheim, Rid
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New York, NY – name: bb Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University, Baltimore, MD – name: a Department of Anesthesiology and Perioperative Medicine, University of Rochester Medical Center, Rochester, NY – name: o Division of Translational Research, NINDS, NIH, 6001, Executive Boulevard, Rockville MD – name: b Department of Psychiatry, University of Rochester Medical Center, Rochester, NY – name: h Centre for Pain Research, The University of Bath, UK – name: l Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania, Philadelphia, PA – name: q Department of Rehabilitation Medicine, University of Washington, Seattle, WA – name: s Tufts University School of Medicine, Boston, MA – name: u Allergan, Irvine, CA – name: v Endo Pharmaceuticals Inc., Malvern, PA – name: t Analgesic Solutions, Wayland, MA – name: dd Clinical Pharmacology Lab, Faculdade de Medicina de Lisboa, University Lisbon, Portugal – name: cc Department of Anesthesia, UCSF School of Medicine, and Research Institute, CPMC Sutter Health, San Francisco, CA – name: r Roderick Junor Eisai Limited – name: gg Department of Epidemiology at the UAB School of Public Health, Birmingham, AL – name: d Center for Health and Technology, University of Rochester Medical Center, Rochester, NY – name: e Anesthesiology and Pain Medicine, University of Washington, Seattle, WA – name: f Department of Psychiatry, Yale School of Medicine, CT – name: kk NeurogesX, Inc., San Mateo, CA – name: z Division of Rheumatology Research, Swedish Medical Center/Providence St. Joseph Health and University of Washington, Seattle, WA – name: c Department of Neurology, University of Rochester Medical Center, Rochester, NY – name: k Pfizer,Inc (current affiliation: Emeritus Professor, Duke University School of Medicine) – name: w DURECT Corporation (current: Scilex Pharmaceuticals, Inc.) – name: hh Chief Medical Officer SVP Neumentum, Inc. 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Snippet	Chronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a composite... ABSTRACTChronic pain clinical trials have historically assessed benefit and risk outcomes separately. However, a growing body of research suggests that a...
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SubjectTerms	Chronic Pain - diagnosis Chronic Pain - therapy Humans Outcome Assessment, Health Care Pain Measurement - methods Risk Assessment
Title	Benefit–risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations
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