Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives
BACKGROUND. This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials. METHODS. A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institu...
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| Veröffentlicht in: | Cancer 2010-07, Vol.116 (13), p.3244-3250 |
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| container_title | Cancer |
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| creator | Yap, Tsiao Yi Yamokoski, Amy D. Hizlan, Sabahat Zyzanski, Stephen J. Angiolillo, Anne L. Rheingold, Susan R. Baker, Justin N. Kodish, Eric D. |
| description | BACKGROUND.
This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.
METHODS.
A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.
RESULTS.
Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no‐attempt‐to‐influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open‐ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician‐family communication.
CONCLUSIONS.
Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010. © 2010 American Cancer Society.
One key to understanding and ultimately improving the quality of informed consent (IC) for pediatric phase 1 cancer trials is to better understand the views of pediatric oncologists at the nexus of investigational medicine and clinical care. Gaining insights into physicians' experiences with, and opinions of, the IC process in this sensitive context enhances future research and education efforts around this ethically challenging topic. |
| doi_str_mv | 10.1002/cncr.25158 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_733580754</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>733580754</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3948-fee3cd2875146e3e4d943aa1a413ec545fdd666c199f4ca4d7c99be8b01d2a0a3</originalsourceid><addsrcrecordid>eNp90F1LwzAUgOEgipvTG3-A9EYGQmc-28Y7GX4MxhRR8K5kp6cs0rU16ZT9ezM39c6rcMLDCXkJOWV0xCjll1CDG3HFVLZH-ozqNKZM8n3Sp5RmsZLitUeOvH8LY8qVOCQ9TlUiE570yWxSl41bYhFBU3usuyiMUYuFNZ2zELUL4zFiEZga0EXhzlT-KnpcrL0Fa2o_DNj5FqGzH-iPyUEZAJ7szgF5ub15Ht_H04e7yfh6GoPQMotLRAEFz1LFZIICZaGlMIYZyQSCkqosiiRJgGldSjCySEHrOWZzygpuqBEDMtzubV3zvkLf5UvrAavK1NisfJ4KoTKahr8PyMVWgmu8d1jmrbNL49Y5o_kmX77Jl3_nC_hst3Y1D01-6U-vAM53wHgwVelCFuv_HNeUaaWCY1v3aStc__NkPp6Nn7aPfwHwgYfh</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>733580754</pqid></control><display><type>article</type><title>Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives</title><source>Wiley Free Content</source><source>MEDLINE</source><source>Wiley Online Library Journals Frontfile Complete</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Yap, Tsiao Yi ; Yamokoski, Amy D. ; Hizlan, Sabahat ; Zyzanski, Stephen J. ; Angiolillo, Anne L. ; Rheingold, Susan R. ; Baker, Justin N. ; Kodish, Eric D.</creator><creatorcontrib>Yap, Tsiao Yi ; Yamokoski, Amy D. ; Hizlan, Sabahat ; Zyzanski, Stephen J. ; Angiolillo, Anne L. ; Rheingold, Susan R. ; Baker, Justin N. ; Kodish, Eric D. ; Phase I Informed Consent (POIC) Research Team</creatorcontrib><description>BACKGROUND.
This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.
METHODS.
A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.
RESULTS.
Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no‐attempt‐to‐influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open‐ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician‐family communication.
CONCLUSIONS.
Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010. © 2010 American Cancer Society.
One key to understanding and ultimately improving the quality of informed consent (IC) for pediatric phase 1 cancer trials is to better understand the views of pediatric oncologists at the nexus of investigational medicine and clinical care. Gaining insights into physicians' experiences with, and opinions of, the IC process in this sensitive context enhances future research and education efforts around this ethically challenging topic.</description><identifier>ISSN: 0008-543X</identifier><identifier>EISSN: 1097-0142</identifier><identifier>DOI: 10.1002/cncr.25158</identifier><identifier>PMID: 20564626</identifier><identifier>CODEN: CANCAR</identifier><language>eng</language><publisher>Hoboken: Wiley Subscription Services, Inc., A Wiley Company</publisher><subject>Adult ; Attitude of Health Personnel ; Biological and medical sciences ; Clinical Trials, Phase I as Topic ; ethics ; Female ; Health Care Surveys ; Humans ; Informed Consent ; Male ; Medical Oncology ; Medical sciences ; Neoplasms - therapy ; Parental Consent ; pediatric oncology ; Pediatrics ; phase 1 trials ; Physician's Role ; Physician-Patient Relations ; physicians' perspectives ; Practice Patterns, Physicians ; Surveys and Questionnaires ; Tumors</subject><ispartof>Cancer, 2010-07, Vol.116 (13), p.3244-3250</ispartof><rights>Copyright © 2010 American Cancer Society</rights><rights>2015 INIST-CNRS</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3948-fee3cd2875146e3e4d943aa1a413ec545fdd666c199f4ca4d7c99be8b01d2a0a3</citedby><cites>FETCH-LOGICAL-c3948-fee3cd2875146e3e4d943aa1a413ec545fdd666c199f4ca4d7c99be8b01d2a0a3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fcncr.25158$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fcncr.25158$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,776,780,1411,1427,27903,27904,45553,45554,46387,46811</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=22901955$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/20564626$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Yap, Tsiao Yi</creatorcontrib><creatorcontrib>Yamokoski, Amy D.</creatorcontrib><creatorcontrib>Hizlan, Sabahat</creatorcontrib><creatorcontrib>Zyzanski, Stephen J.</creatorcontrib><creatorcontrib>Angiolillo, Anne L.</creatorcontrib><creatorcontrib>Rheingold, Susan R.</creatorcontrib><creatorcontrib>Baker, Justin N.</creatorcontrib><creatorcontrib>Kodish, Eric D.</creatorcontrib><creatorcontrib>Phase I Informed Consent (POIC) Research Team</creatorcontrib><title>Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives</title><title>Cancer</title><addtitle>Cancer</addtitle><description>BACKGROUND.
This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.
METHODS.
A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.
RESULTS.
Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no‐attempt‐to‐influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open‐ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician‐family communication.
CONCLUSIONS.
Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010. © 2010 American Cancer Society.
One key to understanding and ultimately improving the quality of informed consent (IC) for pediatric phase 1 cancer trials is to better understand the views of pediatric oncologists at the nexus of investigational medicine and clinical care. Gaining insights into physicians' experiences with, and opinions of, the IC process in this sensitive context enhances future research and education efforts around this ethically challenging topic.</description><subject>Adult</subject><subject>Attitude of Health Personnel</subject><subject>Biological and medical sciences</subject><subject>Clinical Trials, Phase I as Topic</subject><subject>ethics</subject><subject>Female</subject><subject>Health Care Surveys</subject><subject>Humans</subject><subject>Informed Consent</subject><subject>Male</subject><subject>Medical Oncology</subject><subject>Medical sciences</subject><subject>Neoplasms - therapy</subject><subject>Parental Consent</subject><subject>pediatric oncology</subject><subject>Pediatrics</subject><subject>phase 1 trials</subject><subject>Physician's Role</subject><subject>Physician-Patient Relations</subject><subject>physicians' perspectives</subject><subject>Practice Patterns, Physicians</subject><subject>Surveys and Questionnaires</subject><subject>Tumors</subject><issn>0008-543X</issn><issn>1097-0142</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2010</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp90F1LwzAUgOEgipvTG3-A9EYGQmc-28Y7GX4MxhRR8K5kp6cs0rU16ZT9ezM39c6rcMLDCXkJOWV0xCjll1CDG3HFVLZH-ozqNKZM8n3Sp5RmsZLitUeOvH8LY8qVOCQ9TlUiE570yWxSl41bYhFBU3usuyiMUYuFNZ2zELUL4zFiEZga0EXhzlT-KnpcrL0Fa2o_DNj5FqGzH-iPyUEZAJ7szgF5ub15Ht_H04e7yfh6GoPQMotLRAEFz1LFZIICZaGlMIYZyQSCkqosiiRJgGldSjCySEHrOWZzygpuqBEDMtzubV3zvkLf5UvrAavK1NisfJ4KoTKahr8PyMVWgmu8d1jmrbNL49Y5o_kmX77Jl3_nC_hst3Y1D01-6U-vAM53wHgwVelCFuv_HNeUaaWCY1v3aStc__NkPp6Nn7aPfwHwgYfh</recordid><startdate>20100701</startdate><enddate>20100701</enddate><creator>Yap, Tsiao Yi</creator><creator>Yamokoski, Amy D.</creator><creator>Hizlan, Sabahat</creator><creator>Zyzanski, Stephen J.</creator><creator>Angiolillo, Anne L.</creator><creator>Rheingold, Susan R.</creator><creator>Baker, Justin N.</creator><creator>Kodish, Eric D.</creator><general>Wiley Subscription Services, Inc., A Wiley Company</general><general>Wiley-Blackwell</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope></search><sort><creationdate>20100701</creationdate><title>Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives</title><author>Yap, Tsiao Yi ; Yamokoski, Amy D. ; Hizlan, Sabahat ; Zyzanski, Stephen J. ; Angiolillo, Anne L. ; Rheingold, Susan R. ; Baker, Justin N. ; Kodish, Eric D.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3948-fee3cd2875146e3e4d943aa1a413ec545fdd666c199f4ca4d7c99be8b01d2a0a3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2010</creationdate><topic>Adult</topic><topic>Attitude of Health Personnel</topic><topic>Biological and medical sciences</topic><topic>Clinical Trials, Phase I as Topic</topic><topic>ethics</topic><topic>Female</topic><topic>Health Care Surveys</topic><topic>Humans</topic><topic>Informed Consent</topic><topic>Male</topic><topic>Medical Oncology</topic><topic>Medical sciences</topic><topic>Neoplasms - therapy</topic><topic>Parental Consent</topic><topic>pediatric oncology</topic><topic>Pediatrics</topic><topic>phase 1 trials</topic><topic>Physician's Role</topic><topic>Physician-Patient Relations</topic><topic>physicians' perspectives</topic><topic>Practice Patterns, Physicians</topic><topic>Surveys and Questionnaires</topic><topic>Tumors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Yap, Tsiao Yi</creatorcontrib><creatorcontrib>Yamokoski, Amy D.</creatorcontrib><creatorcontrib>Hizlan, Sabahat</creatorcontrib><creatorcontrib>Zyzanski, Stephen J.</creatorcontrib><creatorcontrib>Angiolillo, Anne L.</creatorcontrib><creatorcontrib>Rheingold, Susan R.</creatorcontrib><creatorcontrib>Baker, Justin N.</creatorcontrib><creatorcontrib>Kodish, Eric D.</creatorcontrib><creatorcontrib>Phase I Informed Consent (POIC) Research Team</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Yap, Tsiao Yi</au><au>Yamokoski, Amy D.</au><au>Hizlan, Sabahat</au><au>Zyzanski, Stephen J.</au><au>Angiolillo, Anne L.</au><au>Rheingold, Susan R.</au><au>Baker, Justin N.</au><au>Kodish, Eric D.</au><aucorp>Phase I Informed Consent (POIC) Research Team</aucorp><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives</atitle><jtitle>Cancer</jtitle><addtitle>Cancer</addtitle><date>2010-07-01</date><risdate>2010</risdate><volume>116</volume><issue>13</issue><spage>3244</spage><epage>3250</epage><pages>3244-3250</pages><issn>0008-543X</issn><eissn>1097-0142</eissn><coden>CANCAR</coden><abstract>BACKGROUND.
This study was conducted to gather pediatric oncologists' opinions about and suggestions for improvement of informed consent (IC) in pediatric phase 1 cancer trials.
METHODS.
A questionnaire designed to elicit perspectives was distributed to 146 physicians at 6 participating institutions. A total of 103 completed surveys were returned for a 71% response rate.
RESULTS.
Pediatric oncologists believe providing information so families can decide about phase 1 study entry is the most important goal of the IC process (ICP). The majority of physicians (64%) report that they describe the phase 1 study without any attempt to influence parents' decisions. Several answers provided by physicians were associated with their gender and prior IC training. Male physicians were significantly more likely to endorse the no‐attempt‐to‐influence approach, whereas female physicians were more likely to suggest to parents that other children will benefit from what is learned in phase 1 studies. Responses to an open‐ended question provided 63 suggestions for improvement of the ICP, including document and training changes and tools to enhance physician‐family communication.
CONCLUSIONS.
Pediatric oncologists tended to present phase 1 trials as an option rather than a strong recommendation and were reluctant to influence decisions of families about these studies. They believe most but not all parents understand key concepts involved in consent to this type of research, and had ample suggestions for how to improve the ICP. Future research and education efforts around this ethically challenging topic were warranted. Cancer 2010. © 2010 American Cancer Society.
One key to understanding and ultimately improving the quality of informed consent (IC) for pediatric phase 1 cancer trials is to better understand the views of pediatric oncologists at the nexus of investigational medicine and clinical care. Gaining insights into physicians' experiences with, and opinions of, the IC process in this sensitive context enhances future research and education efforts around this ethically challenging topic.</abstract><cop>Hoboken</cop><pub>Wiley Subscription Services, Inc., A Wiley Company</pub><pmid>20564626</pmid><doi>10.1002/cncr.25158</doi><tpages>7</tpages><oa>free_for_read</oa></addata></record> |
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| subjects | Adult Attitude of Health Personnel Biological and medical sciences Clinical Trials, Phase I as Topic ethics Female Health Care Surveys Humans Informed Consent Male Medical Oncology Medical sciences Neoplasms - therapy Parental Consent pediatric oncology Pediatrics phase 1 trials Physician's Role Physician-Patient Relations physicians' perspectives Practice Patterns, Physicians Surveys and Questionnaires Tumors |
| title | Informed consent for pediatric phase 1 cancer trials: Physicians' perspectives |
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