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Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target
Introduction: Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail. Methods: Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we...
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Published in: | British journal of pain 2020-08, Vol.14 (3), p.171-179 |
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container_title | British journal of pain |
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creator | Bisla, Jatinder Ambler, Gareth Frank, Bernhard Gulati, Sumit Hocken, Poppy James, Mairi Kelly, Joanna Keshet-Price, Jocelyn McCabe, Candy McGylnn, Deborah Padfield, Nick Pang, David Pout, Gill Sanders, Mark Serpell, Mick Shenker, Nicholas Shoukrey, Karim Wesley, Samuel Weston, Margaret White-Alao, Beverly Wyatt, Lynne Murphy, Caroline Goebel, Andreas |
description | Introduction:
Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail.
Methods:
Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we have identified recruitment and retention strategies for successful trial conduct.
Results:
We present 13 strategies grouped across the categories of ‘setting the recruitment rate’, ‘networking’, ‘patient information’, ‘trial management’ and ‘patient retention’. Moreover, six recruitment risks are also discussed. A conservative recruitment estimate, based on audits of newly referred patients to the trial centres without taking into account availability of ‘old’ patients or recruitment from outside centres, and assuming a 55% patient refusal rate yielded accurate numbers.
Conclusion:
Appreciation of these identified recruitment challenges and opportunities may contribute to supporting prospective investigators when they design clinical trials for chronic pain patient population groups where it has been historically difficult to conduct high-quality and robust clinical trials. |
doi_str_mv | 10.1177/2049463719893399 |
format | article |
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Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail.
Methods:
Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we have identified recruitment and retention strategies for successful trial conduct.
Results:
We present 13 strategies grouped across the categories of ‘setting the recruitment rate’, ‘networking’, ‘patient information’, ‘trial management’ and ‘patient retention’. Moreover, six recruitment risks are also discussed. A conservative recruitment estimate, based on audits of newly referred patients to the trial centres without taking into account availability of ‘old’ patients or recruitment from outside centres, and assuming a 55% patient refusal rate yielded accurate numbers.
Conclusion:
Appreciation of these identified recruitment challenges and opportunities may contribute to supporting prospective investigators when they design clinical trials for chronic pain patient population groups where it has been historically difficult to conduct high-quality and robust clinical trials.</description><identifier>ISSN: 2049-4637</identifier><identifier>EISSN: 2049-4645</identifier><identifier>DOI: 10.1177/2049463719893399</identifier><identifier>PMID: 32922778</identifier><language>eng</language><publisher>London, England: SAGE Publications</publisher><ispartof>British journal of pain, 2020-08, Vol.14 (3), p.171-179</ispartof><rights>The British Pain Society 2019</rights><rights>The British Pain Society 2019.</rights><rights>The British Pain Society 2019 2019 British Pain Society</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c434t-7240d189b8bac86836f877ff80cd1706dc9be404a341860f7a32fb481bebdcdd3</citedby><cites>FETCH-LOGICAL-c434t-7240d189b8bac86836f877ff80cd1706dc9be404a341860f7a32fb481bebdcdd3</cites><orcidid>0000-0001-7247-5804</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453479/pdf/$$EPDF$$P50$$Gpubmedcentral$$H</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7453479/$$EHTML$$P50$$Gpubmedcentral$$H</linktohtml><link.rule.ids>230,314,727,780,784,885,27924,27925,53791,53793,79364</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32922778$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Bisla, Jatinder</creatorcontrib><creatorcontrib>Ambler, Gareth</creatorcontrib><creatorcontrib>Frank, Bernhard</creatorcontrib><creatorcontrib>Gulati, Sumit</creatorcontrib><creatorcontrib>Hocken, Poppy</creatorcontrib><creatorcontrib>James, Mairi</creatorcontrib><creatorcontrib>Kelly, Joanna</creatorcontrib><creatorcontrib>Keshet-Price, Jocelyn</creatorcontrib><creatorcontrib>McCabe, Candy</creatorcontrib><creatorcontrib>McGylnn, Deborah</creatorcontrib><creatorcontrib>Padfield, Nick</creatorcontrib><creatorcontrib>Pang, David</creatorcontrib><creatorcontrib>Pout, Gill</creatorcontrib><creatorcontrib>Sanders, Mark</creatorcontrib><creatorcontrib>Serpell, Mick</creatorcontrib><creatorcontrib>Shenker, Nicholas</creatorcontrib><creatorcontrib>Shoukrey, Karim</creatorcontrib><creatorcontrib>Wesley, Samuel</creatorcontrib><creatorcontrib>Weston, Margaret</creatorcontrib><creatorcontrib>White-Alao, Beverly</creatorcontrib><creatorcontrib>Wyatt, Lynne</creatorcontrib><creatorcontrib>Murphy, Caroline</creatorcontrib><creatorcontrib>Goebel, Andreas</creatorcontrib><title>Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target</title><title>British journal of pain</title><addtitle>Br J Pain</addtitle><description>Introduction:
Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail.
Methods:
Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we have identified recruitment and retention strategies for successful trial conduct.
Results:
We present 13 strategies grouped across the categories of ‘setting the recruitment rate’, ‘networking’, ‘patient information’, ‘trial management’ and ‘patient retention’. Moreover, six recruitment risks are also discussed. A conservative recruitment estimate, based on audits of newly referred patients to the trial centres without taking into account availability of ‘old’ patients or recruitment from outside centres, and assuming a 55% patient refusal rate yielded accurate numbers.
Conclusion:
Appreciation of these identified recruitment challenges and opportunities may contribute to supporting prospective investigators when they design clinical trials for chronic pain patient population groups where it has been historically difficult to conduct high-quality and robust clinical trials.</description><issn>2049-4637</issn><issn>2049-4645</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><recordid>eNp1UU1vFSEUJUZjm9q9K8PSzSgMvAE2JqbxK23iQrsmDNyZRzMDTz5q_DX-Vel79VVNZAP3nHMPFw5Czyl5RakQr3vCFR-YoEoqxpR6hE7voI4PfPP4eGbiBJ3nfEPakpQpLp6iE9arvhdCnqKfX6q1kPNUF2yCwzXkByCBTdWXFULZkwmK8WFf5pJMgdlDxj5gg68v8VqX4m0jE2CX6oxL8mbBU0yNT6ahdpti8Bbvmgu2MThffAz4-9bbLd5BatIVHDZjvAVcTJqhPENPJrNkOL_fz9D1-3dfLz52V58_fLp4e9VZznjpRM-Jo1KNcjRWDpINkxRimiSxjgoyOKtG4IQbxqkcyCQM66eRSzrC6Kxz7Ay9Ofju6thm2D_DLHqX_GrSDx2N138zwW_1HG-14BvGhWoGL-8NUvxWIRe9-mxhWUyAWLPuOe83SmwUaVJykNoUc04wHa-hRN9Fq_-NtrW8-HO8Y8PvIJugOwiymUHfxJpC-67_G_4CLj2w-Q</recordid><startdate>20200801</startdate><enddate>20200801</enddate><creator>Bisla, Jatinder</creator><creator>Ambler, Gareth</creator><creator>Frank, Bernhard</creator><creator>Gulati, Sumit</creator><creator>Hocken, Poppy</creator><creator>James, Mairi</creator><creator>Kelly, Joanna</creator><creator>Keshet-Price, Jocelyn</creator><creator>McCabe, Candy</creator><creator>McGylnn, Deborah</creator><creator>Padfield, Nick</creator><creator>Pang, David</creator><creator>Pout, Gill</creator><creator>Sanders, Mark</creator><creator>Serpell, Mick</creator><creator>Shenker, Nicholas</creator><creator>Shoukrey, Karim</creator><creator>Wesley, Samuel</creator><creator>Weston, Margaret</creator><creator>White-Alao, Beverly</creator><creator>Wyatt, Lynne</creator><creator>Murphy, Caroline</creator><creator>Goebel, Andreas</creator><general>SAGE Publications</general><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0001-7247-5804</orcidid></search><sort><creationdate>20200801</creationdate><title>Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target</title><author>Bisla, Jatinder ; Ambler, Gareth ; Frank, Bernhard ; Gulati, Sumit ; Hocken, Poppy ; James, Mairi ; Kelly, Joanna ; Keshet-Price, Jocelyn ; McCabe, Candy ; McGylnn, Deborah ; Padfield, Nick ; Pang, David ; Pout, Gill ; Sanders, Mark ; Serpell, Mick ; Shenker, Nicholas ; Shoukrey, Karim ; Wesley, Samuel ; Weston, Margaret ; White-Alao, Beverly ; Wyatt, Lynne ; Murphy, Caroline ; Goebel, Andreas</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c434t-7240d189b8bac86836f877ff80cd1706dc9be404a341860f7a32fb481bebdcdd3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Bisla, Jatinder</creatorcontrib><creatorcontrib>Ambler, Gareth</creatorcontrib><creatorcontrib>Frank, Bernhard</creatorcontrib><creatorcontrib>Gulati, Sumit</creatorcontrib><creatorcontrib>Hocken, Poppy</creatorcontrib><creatorcontrib>James, Mairi</creatorcontrib><creatorcontrib>Kelly, Joanna</creatorcontrib><creatorcontrib>Keshet-Price, Jocelyn</creatorcontrib><creatorcontrib>McCabe, Candy</creatorcontrib><creatorcontrib>McGylnn, Deborah</creatorcontrib><creatorcontrib>Padfield, Nick</creatorcontrib><creatorcontrib>Pang, David</creatorcontrib><creatorcontrib>Pout, Gill</creatorcontrib><creatorcontrib>Sanders, Mark</creatorcontrib><creatorcontrib>Serpell, Mick</creatorcontrib><creatorcontrib>Shenker, Nicholas</creatorcontrib><creatorcontrib>Shoukrey, Karim</creatorcontrib><creatorcontrib>Wesley, Samuel</creatorcontrib><creatorcontrib>Weston, Margaret</creatorcontrib><creatorcontrib>White-Alao, Beverly</creatorcontrib><creatorcontrib>Wyatt, Lynne</creatorcontrib><creatorcontrib>Murphy, Caroline</creatorcontrib><creatorcontrib>Goebel, Andreas</creatorcontrib><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of pain</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Bisla, Jatinder</au><au>Ambler, Gareth</au><au>Frank, Bernhard</au><au>Gulati, Sumit</au><au>Hocken, Poppy</au><au>James, Mairi</au><au>Kelly, Joanna</au><au>Keshet-Price, Jocelyn</au><au>McCabe, Candy</au><au>McGylnn, Deborah</au><au>Padfield, Nick</au><au>Pang, David</au><au>Pout, Gill</au><au>Sanders, Mark</au><au>Serpell, Mick</au><au>Shenker, Nicholas</au><au>Shoukrey, Karim</au><au>Wesley, Samuel</au><au>Weston, Margaret</au><au>White-Alao, Beverly</au><au>Wyatt, Lynne</au><au>Murphy, Caroline</au><au>Goebel, Andreas</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target</atitle><jtitle>British journal of pain</jtitle><addtitle>Br J Pain</addtitle><date>2020-08-01</date><risdate>2020</risdate><volume>14</volume><issue>3</issue><spage>171</spage><epage>179</epage><pages>171-179</pages><issn>2049-4637</issn><eissn>2049-4645</eissn><abstract>Introduction:
Recruitment into trials in rare chronic pain conditions can be challenging, so such trials consequently are underpowered or fail.
Methods:
Drawing from our experience in conducting, to date, the largest academic trial in a rare chronic pain condition, complex regional pain syndrome, we have identified recruitment and retention strategies for successful trial conduct.
Results:
We present 13 strategies grouped across the categories of ‘setting the recruitment rate’, ‘networking’, ‘patient information’, ‘trial management’ and ‘patient retention’. Moreover, six recruitment risks are also discussed. A conservative recruitment estimate, based on audits of newly referred patients to the trial centres without taking into account availability of ‘old’ patients or recruitment from outside centres, and assuming a 55% patient refusal rate yielded accurate numbers.
Conclusion:
Appreciation of these identified recruitment challenges and opportunities may contribute to supporting prospective investigators when they design clinical trials for chronic pain patient population groups where it has been historically difficult to conduct high-quality and robust clinical trials.</abstract><cop>London, England</cop><pub>SAGE Publications</pub><pmid>32922778</pmid><doi>10.1177/2049463719893399</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0001-7247-5804</orcidid><oa>free_for_read</oa></addata></record> |
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title | Successful and unsuccessful recruitment and retainment strategies in a UK multicentre drug trial for a rare chronic pain condition which performed above target |
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