Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations

Jennifer S. Gewandter; Robert H. Dworkin; Dennis C. Turk; Eric G. Devine; David Hewitt; Mark P. Jensen; Nathaniel P. Katz; Amy A. Kirkwood; Richard Malamut; John D. Markman; Bernard Vrijens; Laurie Burke; James N. Campbell; Daniel B. Carr; Philip G. Conaghan; Penney Cowan; Mittie K. Doyle; Robert R. Edwards; Scott R. Evans; John T. Farrar; Roy Freeman; Ian Gilron; Dean Juge; Robert D. Kerns; Ernest A. Kopecky; Michael P. McDermott; Gwendolyn Niebler; Kushang V. Patel; Richard Rauck; Andrew S.C. Rice; Michael Rowbotham; Nelson E. Sessler; Lee S. Simon; Neil Singla; Vladimir Skljarevski; Tina Tockarshewsky; Geertrui F. Vanhove; Ajay D. Wasan; James Witter

doi:10.1016/j.jpain.2019.12.003

Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations

Jennifer S. Gewandter, Robert H. Dworkin, Dennis C. Turk, Eric G. Devine, David Hewitt, Mark P. Jensen, Nathaniel P. Katz, Amy A. Kirkwood, Richard Malamut, John D. Markman, Bernard Vrijens, Laurie Burke, James N. Campbell, Daniel B. Carr, Philip G. Conaghan, Penney Cowan, Mittie K. Doyle, Robert R. Edwards, Scott R. Evans, John T. FarrarRoy Freeman, Ian Gilron, Dean Juge, Robert D. Kerns, Ernest A. Kopecky, Michael P. McDermott, Gwendolyn Niebler, Kushang V. Patel, Richard Rauck, Andrew S.C. Rice, Michael Rowbotham, Nelson E. Sessler, Lee S. Simon, Neil Singla, Vladimir Skljarevski, Tina Tockarshewsky, Geertrui F. Vanhove, Ajay D. Wasan, James Witter

Research output: Contribution to journal › Review article › peer-review

6 Scopus citations

Abstract

The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. Perspective: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry.

Original language	English (US)
Pages (from-to)	931-942
Number of pages	12
Journal	Journal of Pain
Volume	21
Issue number	9-10
DOIs	https://doi.org/10.1016/j.jpain.2019.12.003
State	Published - Sep 1 2020
Externally published	Yes

Keywords

Data quality
Initiative on Methods
Measurement
and Pain Assessment in Clinical Trials
clinical trial conduct

ASJC Scopus subject areas

Neurology
Clinical Neurology
Anesthesiology and Pain Medicine

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10.1016/j.jpain.2019.12.003

Cite this

Gewandter, J. S., Dworkin, R. H., Turk, D. C., Devine, E. G., Hewitt, D., Jensen, M. P., Katz, N. P., Kirkwood, A. A., Malamut, R., Markman, J. D., Vrijens, B., Burke, L., Campbell, J. N., Carr, D. B., Conaghan, P. G., Cowan, P., Doyle, M. K., Edwards, R. R., Evans, S. R., ... Witter, J. (2020). Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations. Journal of Pain, 21(9-10), 931-942. https://doi.org/10.1016/j.jpain.2019.12.003

Gewandter, JS, Dworkin, RH, Turk, DC, Devine, EG, Hewitt, D, Jensen, MP, Katz, NP, Kirkwood, AA, Malamut, R, Markman, JD, Vrijens, B, Burke, L, Campbell, JN, Carr, DB, Conaghan, PG, Cowan, P, Doyle, MK, Edwards, RR, Evans, SR, Farrar, JT, Freeman, R, Gilron, I, Juge, D, Kerns, RD, Kopecky, EA, McDermott, MP, Niebler, G, Patel, KV, Rauck, R, Rice, ASC, Rowbotham, M, Sessler, NE, Simon, LS, Singla, N, Skljarevski, V, Tockarshewsky, T, Vanhove, GF, Wasan, AD & Witter, J 2020, 'Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations', Journal of Pain, vol. 21, no. 9-10, pp. 931-942. https://doi.org/10.1016/j.jpain.2019.12.003

@article{7bd3fe4d28704d419c571325e48cebdd,

title = "Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations",

abstract = "The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. Perspective: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry.",

keywords = "Data quality, Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, clinical trial conduct",

author = "Gewandter, {Jennifer S.} and Dworkin, {Robert H.} and Turk, {Dennis C.} and Devine, {Eric G.} and David Hewitt and Jensen, {Mark P.} and Katz, {Nathaniel P.} and Kirkwood, {Amy A.} and Richard Malamut and Markman, {John D.} and Bernard Vrijens and Laurie Burke and Campbell, {James N.} and Carr, {Daniel B.} and Conaghan, {Philip G.} and Penney Cowan and Doyle, {Mittie K.} and Edwards, {Robert R.} and Evans, {Scott R.} and Farrar, {John T.} and Roy Freeman and Ian Gilron and Dean Juge and Kerns, {Robert D.} and Kopecky, {Ernest A.} and McDermott, {Michael P.} and Gwendolyn Niebler and Patel, {Kushang V.} and Richard Rauck and Rice, {Andrew S.C.} and Michael Rowbotham and Sessler, {Nelson E.} and Simon, {Lee S.} and Neil Singla and Vladimir Skljarevski and Tina Tockarshewsky and Vanhove, {Geertrui F.} and Wasan, {Ajay D.} and James Witter",

note = "Funding Information: Philip Conaghan has done consultancies or speakers bureaus for AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GlaxoSmithKline, Kolon TissueGene, Medivir, Novartis, Pfizer, Roche, Samumed and Stryker. P. Conaghan is supported in part by the UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre. Funding Information: This article was reviewed and approved by the Executive Committee of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the United States Food and Drug Administration. Financial support for this project was provided by the ACTTION public-private partnership which has received unrestricted research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, and other sources. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding Information: Mark P. Jensen has received in the past 36 months research grants from the National Institutes of Health, the National Multiple Sclerosis Society, the Patient-Centered Outcomes Research Institute, The International Association for the Study of Pain, and the Washington State Spinal Injury Consortium. He has also received compensation for consultation from Goalistics. Funding Information: Eric Devine has grant and contract funding from NIAAA and NIDA as part of his salary support at Boston University. This includes reimbursed travel expenses to attend study kick-off meetings. Dr. Devine has received travel reimbursement from NIDA to participate as a speaker at an international conference. He has also received travel reimbursement from NIAAA to serve on a grant review committee. Dr. Devine has received teaching stipends from Adcare Educational Institute for conducting workshops on motivational interviewing and substance use treatment. He does not have individual investments, stocks, intellectual property in any healthcare-related industries. Funding Information: In the past 5 years, Daniel Carr has received consulting fees from 1 startup company (no longer in business), for advice on potential acquisitions of nonopioid analgesics. To his knowledge, none were subsequently marketed. He has been an officer and member of professional associations that accept contributions from the pharmaceutical and medical device industries and use these and other revenues such as membership dues to cover officers? expenses connected with their operations (eg, attending board or planning meetings). Dr Carr does not have investments, stock options or other holdings in such contributors. Other than ACTTION, these associations are the American Academy of Pain Medicine; the American Society of Anesthesiologists; the European Pain Federation; and the International Association for the Study of Pain (as a participant or representative at meetings or hearings). As a member of the National Institutes of Health (NIH) Interagency Pain Research Coordinating Committee/National Pain Strategy, he has received travel expenses from NIH to attend their meetings. Additionally, he has received or anticipates potentially receiving personal payments (including travel expenses) for occasional participation as an expert witness; service on an NIH-sponsored data safety monitoring board for a clinical trial; participation in a workshop convened by the National Academies of Science, Engineering and Medicine; and consultant fees from the Federal Trade Commission. He has received modest honoraria for participation in accredited medical education activities.Eric Devine has grant and contract funding from NIAAA and NIDA as part of his salary support at Boston University. This includes reimbursed travel expenses to attend study kick-off meetings. Dr. Devine has received travel reimbursement from NIDA to participate as a speaker at an international conference. He has also received travel reimbursement from NIAAA to serve on a grant review committee. Dr. Devine has received teaching stipends from Adcare Educational Institute for conducting workshops on motivational interviewing and substance use treatment. He does not have individual investments, stocks, intellectual property in any healthcare-related industries.Robert H. Dworkin has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health, and compensation for consulting on clinical trial methods from Abide, Adynxx, Analgesic Solutions, Aptinyx, Asahi Kasei, Astellas, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Celgene, Centrexion, Chromocell, Clexio, Concert, Dong-A, Eli Lilly, Eupraxia, Glenmark, Grace, Hope, Immune, Neumentum, NeuroBo, Novaremed, Novartis, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy, Relmada, Sandoz, Scilex, Semnur, Sollis, Teva, Theranexus, Trevena, and Vertex.Ian Gilron has received support from Biogen, Adynxx, TARIS Biomedical, Astra-Zeneca, Pfizer, and Johnson & Johnson and has received grants from the Canadian Institutes of Health Research, Physicians? Services Incorporated Foundation, and Queen's University. Financial Disclosure: The views expressed in this article are those of the authors and no official endorsement by the Food and Drug Administration (FDA) or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public-private partnership should be inferred. Disclosures by individual authors are as follows: John T. Farrar, in the past 36 months has received: research grants and contracts from US Food and Drug Administration and US National Institutes of Health; compensation for consulting on clinical trial methods from Analgesic Solutions, Aptinyx, Biogen, Campbell Alliance, Daiichi Sankyo, DepoMed, Evadera, Jansen, Lilly, Novartis, and Pfizer; DSMB services from NIH-NIA and Cara Therapeutics; and services as associate editor from Wiley. Mark P. Jensen has received in the past 36 months research grants from the National Institutes of Health, the National Multiple Sclerosis Society, the Patient-Centered Outcomes Research Institute, The International Association for the Study of Pain, and the Washington State Spinal Injury Consortium. He has also received compensation for consultation from Goalistics. Robert Kerns has received research funding from NIH, PCORI, Department of Veterans Affairs, Consortium of MS Centers and Honoraria from the American Academy of Pain Medicine (editorial board of Pain Medicine), American Pain Society (reviewer for APS-Pfizer grant program), American Care Management Association (Speaker), American College of Physicians (Speaker), Health Education Resource Organization (Speaker), and Duke University School of Medicine (Speaker). Amy A Kirkwood is funded by Cancer Research UK. Michael P. McDermott has been supported in the past 36 months by research grants from NIH, FDA, NYSTEM, SMA Foundation, Cure SMA, and PTC Therapeutics. He has received compensation for consulting from Neuropore Therapies, Inc and Voyager Therapeutics. He has served on Data and Safety Monitoring Boards (DSMBs) for NIH, Novartis Pharmaceuticals Corporation, AstraZeneca, Eli Lilly and Company, aTyr Pharma, Inc, Catabasis Pharmaceuticals, Inc, Vaccinex, Inc, Cynapsus Therapeutics, and Voyager Therapeutics. Kushang Patel has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health. Ajay D. Wasan has received in the past 36 months research grants and contracts from US National Institutes of Health, the Patient Centered Outcomes Research Institute, and Collegium Pharmaceuticals. He has received compensation for consulting from Pfizer and Analgesic Solutions. Publisher Copyright: {\textcopyright} 2020",

year = "2020",

month = sep,

day = "1",

doi = "10.1016/j.jpain.2019.12.003",

language = "English (US)",

volume = "21",

pages = "931--942",

journal = "Journal of Pain",

issn = "1526-5900",

publisher = "Churchill Livingstone",

number = "9-10",

}

TY - JOUR

T1 - Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments

T2 - IMMPACT Recommendations

AU - Gewandter, Jennifer S.

AU - Dworkin, Robert H.

AU - Turk, Dennis C.

AU - Devine, Eric G.

AU - Hewitt, David

AU - Jensen, Mark P.

AU - Katz, Nathaniel P.

AU - Kirkwood, Amy A.

AU - Malamut, Richard

AU - Markman, John D.

AU - Vrijens, Bernard

AU - Burke, Laurie

AU - Campbell, James N.

AU - Carr, Daniel B.

AU - Conaghan, Philip G.

AU - Cowan, Penney

AU - Doyle, Mittie K.

AU - Edwards, Robert R.

AU - Evans, Scott R.

AU - Farrar, John T.

AU - Freeman, Roy

AU - Gilron, Ian

AU - Juge, Dean

AU - Kerns, Robert D.

AU - Kopecky, Ernest A.

AU - McDermott, Michael P.

AU - Niebler, Gwendolyn

AU - Patel, Kushang V.

AU - Rauck, Richard

AU - Rice, Andrew S.C.

AU - Rowbotham, Michael

AU - Sessler, Nelson E.

AU - Simon, Lee S.

AU - Singla, Neil

AU - Skljarevski, Vladimir

AU - Tockarshewsky, Tina

AU - Vanhove, Geertrui F.

AU - Wasan, Ajay D.

AU - Witter, James

N1 - Funding Information: Philip Conaghan has done consultancies or speakers bureaus for AbbVie, AstraZeneca, Bristol Myers Squibb, Eli Lilly, EMD Serono, Flexion Therapeutics, Galapagos, GlaxoSmithKline, Kolon TissueGene, Medivir, Novartis, Pfizer, Roche, Samumed and Stryker. P. Conaghan is supported in part by the UK National Institute for Health Research (NIHR) Leeds Biomedical Research Centre. Funding Information: This article was reviewed and approved by the Executive Committee of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the United States Food and Drug Administration. Financial support for this project was provided by the ACTTION public-private partnership which has received unrestricted research contracts, grants, or other revenue from the FDA, multiple pharmaceutical and device companies, philanthropy, and other sources. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health. Funding Information: Mark P. Jensen has received in the past 36 months research grants from the National Institutes of Health, the National Multiple Sclerosis Society, the Patient-Centered Outcomes Research Institute, The International Association for the Study of Pain, and the Washington State Spinal Injury Consortium. He has also received compensation for consultation from Goalistics. Funding Information: Eric Devine has grant and contract funding from NIAAA and NIDA as part of his salary support at Boston University. This includes reimbursed travel expenses to attend study kick-off meetings. Dr. Devine has received travel reimbursement from NIDA to participate as a speaker at an international conference. He has also received travel reimbursement from NIAAA to serve on a grant review committee. Dr. Devine has received teaching stipends from Adcare Educational Institute for conducting workshops on motivational interviewing and substance use treatment. He does not have individual investments, stocks, intellectual property in any healthcare-related industries. Funding Information: In the past 5 years, Daniel Carr has received consulting fees from 1 startup company (no longer in business), for advice on potential acquisitions of nonopioid analgesics. To his knowledge, none were subsequently marketed. He has been an officer and member of professional associations that accept contributions from the pharmaceutical and medical device industries and use these and other revenues such as membership dues to cover officers? expenses connected with their operations (eg, attending board or planning meetings). Dr Carr does not have investments, stock options or other holdings in such contributors. Other than ACTTION, these associations are the American Academy of Pain Medicine; the American Society of Anesthesiologists; the European Pain Federation; and the International Association for the Study of Pain (as a participant or representative at meetings or hearings). As a member of the National Institutes of Health (NIH) Interagency Pain Research Coordinating Committee/National Pain Strategy, he has received travel expenses from NIH to attend their meetings. Additionally, he has received or anticipates potentially receiving personal payments (including travel expenses) for occasional participation as an expert witness; service on an NIH-sponsored data safety monitoring board for a clinical trial; participation in a workshop convened by the National Academies of Science, Engineering and Medicine; and consultant fees from the Federal Trade Commission. He has received modest honoraria for participation in accredited medical education activities.Eric Devine has grant and contract funding from NIAAA and NIDA as part of his salary support at Boston University. This includes reimbursed travel expenses to attend study kick-off meetings. Dr. Devine has received travel reimbursement from NIDA to participate as a speaker at an international conference. He has also received travel reimbursement from NIAAA to serve on a grant review committee. Dr. Devine has received teaching stipends from Adcare Educational Institute for conducting workshops on motivational interviewing and substance use treatment. He does not have individual investments, stocks, intellectual property in any healthcare-related industries.Robert H. Dworkin has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health, and compensation for consulting on clinical trial methods from Abide, Adynxx, Analgesic Solutions, Aptinyx, Asahi Kasei, Astellas, AstraZeneca, Biogen, Biohaven, Boston Scientific, Braeburn, Celgene, Centrexion, Chromocell, Clexio, Concert, Dong-A, Eli Lilly, Eupraxia, Glenmark, Grace, Hope, Immune, Neumentum, NeuroBo, Novaremed, Novartis, Pfizer, Phosphagenics, Quark, Reckitt Benckiser, Regenacy, Relmada, Sandoz, Scilex, Semnur, Sollis, Teva, Theranexus, Trevena, and Vertex.Ian Gilron has received support from Biogen, Adynxx, TARIS Biomedical, Astra-Zeneca, Pfizer, and Johnson & Johnson and has received grants from the Canadian Institutes of Health Research, Physicians? Services Incorporated Foundation, and Queen's University. Financial Disclosure: The views expressed in this article are those of the authors and no official endorsement by the Food and Drug Administration (FDA) or the pharmaceutical and device companies that provided unrestricted grants to support the activities of the ACTTION public-private partnership should be inferred. Disclosures by individual authors are as follows: John T. Farrar, in the past 36 months has received: research grants and contracts from US Food and Drug Administration and US National Institutes of Health; compensation for consulting on clinical trial methods from Analgesic Solutions, Aptinyx, Biogen, Campbell Alliance, Daiichi Sankyo, DepoMed, Evadera, Jansen, Lilly, Novartis, and Pfizer; DSMB services from NIH-NIA and Cara Therapeutics; and services as associate editor from Wiley. Mark P. Jensen has received in the past 36 months research grants from the National Institutes of Health, the National Multiple Sclerosis Society, the Patient-Centered Outcomes Research Institute, The International Association for the Study of Pain, and the Washington State Spinal Injury Consortium. He has also received compensation for consultation from Goalistics. Robert Kerns has received research funding from NIH, PCORI, Department of Veterans Affairs, Consortium of MS Centers and Honoraria from the American Academy of Pain Medicine (editorial board of Pain Medicine), American Pain Society (reviewer for APS-Pfizer grant program), American Care Management Association (Speaker), American College of Physicians (Speaker), Health Education Resource Organization (Speaker), and Duke University School of Medicine (Speaker). Amy A Kirkwood is funded by Cancer Research UK. Michael P. McDermott has been supported in the past 36 months by research grants from NIH, FDA, NYSTEM, SMA Foundation, Cure SMA, and PTC Therapeutics. He has received compensation for consulting from Neuropore Therapies, Inc and Voyager Therapeutics. He has served on Data and Safety Monitoring Boards (DSMBs) for NIH, Novartis Pharmaceuticals Corporation, AstraZeneca, Eli Lilly and Company, aTyr Pharma, Inc, Catabasis Pharmaceuticals, Inc, Vaccinex, Inc, Cynapsus Therapeutics, and Voyager Therapeutics. Kushang Patel has received in the past 36 months research grants and contracts from US Food and Drug Administration and US National Institutes of Health. Ajay D. Wasan has received in the past 36 months research grants and contracts from US National Institutes of Health, the Patient Centered Outcomes Research Institute, and Collegium Pharmaceuticals. He has received compensation for consulting from Pfizer and Analgesic Solutions. Publisher Copyright: © 2020

PY - 2020/9/1

Y1 - 2020/9/1

N2 - The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. Perspective: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry.

AB - The estimated probability of progressing from phase 3 analgesic clinical trials to regulatory approval is approximately 57%, suggesting that a considerable number of treatments with phase 2 trial results deemed sufficiently successful to progress to phase 3 do not yield positive phase 3 results. Deficiencies in the quality of clinical trial conduct could account for some of this failure. An Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials meeting was convened to identify potential areas for improvement in trial conduct in order to improve assay sensitivity (ie, ability of trials to detect a true treatment effect). We present recommendations based on presentations and discussions at the meeting, literature reviews, and iterative revisions of this article. The recommendations relate to the following areas: 1) study design (ie, to promote feasibility), 2) site selection and staff training, 3) participant selection and training, 4) treatment adherence, 5) data collection, and 6) data and study monitoring. Implementation of these recommendations may improve the quality of clinical trial data and thus the validity and assay sensitivity of clinical trials. Future research regarding the effects of these strategies will help identify the most efficient use of resources for conducting high quality clinical trials. Perspective: Every effort should be made to optimize the quality of clinical trial data. This manuscript discusses considerations to improve conduct of pain clinical trials based on research in multiple medical fields and the expert consensus of pain researchers and stakeholders from academia, regulatory agencies, and industry.

KW - Data quality

KW - Initiative on Methods

KW - Measurement

KW - and Pain Assessment in Clinical Trials

KW - clinical trial conduct

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SN - 1526-5900

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ER -

Improving Study Conduct and Data Quality in Clinical Trials of Chronic Pain Treatments: IMMPACT Recommendations

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