Quality of reporting of serious adverse drug events to an institutional review board: A case study with the novel cancer agent, imatinib mesylate

David Dorr, Rachel Burdon, Dennis P. West, Jennifer Lagman, Christina Georgopoulos, Steven M. Belknap, June M. McKoy, Benjamin Djulbegovic, Beatrice J. Edwards, Sigmund A. Weitzman, Simone Boyle, Martin S. Tallman, Moshe Talpaz, Oliver Sartor, Charles L. Bennett

Research output: Contribution to journalArticle

17 Citations (Scopus)

Abstract

Purpose: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P <0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P <0.05). Some key clinical information was discrepant between the two sources. Conclusions: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.

Original languageEnglish (US)
Pages (from-to)3850-3855
Number of pages6
JournalClinical Cancer Research
Volume15
Issue number11
DOIs
StatePublished - Jun 1 2009

Fingerprint

Research Ethics Committees
Drug-Related Side Effects and Adverse Reactions
Neoplasms
Causality
Safety
Pharmaceutical Preparations
Drug Approval
Imatinib Mesylate
Information Storage and Retrieval
United States Food and Drug Administration
Research Design
Clinical Trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Quality of reporting of serious adverse drug events to an institutional review board : A case study with the novel cancer agent, imatinib mesylate. / Dorr, David; Burdon, Rachel; West, Dennis P.; Lagman, Jennifer; Georgopoulos, Christina; Belknap, Steven M.; McKoy, June M.; Djulbegovic, Benjamin; Edwards, Beatrice J.; Weitzman, Sigmund A.; Boyle, Simone; Tallman, Martin S.; Talpaz, Moshe; Sartor, Oliver; Bennett, Charles L.

In: Clinical Cancer Research, Vol. 15, No. 11, 01.06.2009, p. 3850-3855.

Research output: Contribution to journalArticle

Dorr, D, Burdon, R, West, DP, Lagman, J, Georgopoulos, C, Belknap, SM, McKoy, JM, Djulbegovic, B, Edwards, BJ, Weitzman, SA, Boyle, S, Tallman, MS, Talpaz, M, Sartor, O & Bennett, CL 2009, 'Quality of reporting of serious adverse drug events to an institutional review board: A case study with the novel cancer agent, imatinib mesylate', Clinical Cancer Research, vol. 15, no. 11, pp. 3850-3855. https://doi.org/10.1158/1078-0432.CCR-08-1811
Dorr, David ; Burdon, Rachel ; West, Dennis P. ; Lagman, Jennifer ; Georgopoulos, Christina ; Belknap, Steven M. ; McKoy, June M. ; Djulbegovic, Benjamin ; Edwards, Beatrice J. ; Weitzman, Sigmund A. ; Boyle, Simone ; Tallman, Martin S. ; Talpaz, Moshe ; Sartor, Oliver ; Bennett, Charles L. / Quality of reporting of serious adverse drug events to an institutional review board : A case study with the novel cancer agent, imatinib mesylate. In: Clinical Cancer Research. 2009 ; Vol. 15, No. 11. pp. 3850-3855.
@article{aa06d51621ce48ef8764f4c03a2ac9ad,
title = "Quality of reporting of serious adverse drug events to an institutional review board: A case study with the novel cancer agent, imatinib mesylate",
abstract = "Purpose: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0{\%} versus 40.3{\%}, P <0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93{\%} versus 26{\%}, P <0.05). Some key clinical information was discrepant between the two sources. Conclusions: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.",
author = "David Dorr and Rachel Burdon and West, {Dennis P.} and Jennifer Lagman and Christina Georgopoulos and Belknap, {Steven M.} and McKoy, {June M.} and Benjamin Djulbegovic and Edwards, {Beatrice J.} and Weitzman, {Sigmund A.} and Simone Boyle and Tallman, {Martin S.} and Moshe Talpaz and Oliver Sartor and Bennett, {Charles L.}",
year = "2009",
month = "6",
day = "1",
doi = "10.1158/1078-0432.CCR-08-1811",
language = "English (US)",
volume = "15",
pages = "3850--3855",
journal = "Clinical Cancer Research",
issn = "1078-0432",
publisher = "American Association for Cancer Research Inc.",
number = "11",

}

TY - JOUR

T1 - Quality of reporting of serious adverse drug events to an institutional review board

T2 - A case study with the novel cancer agent, imatinib mesylate

AU - Dorr, David

AU - Burdon, Rachel

AU - West, Dennis P.

AU - Lagman, Jennifer

AU - Georgopoulos, Christina

AU - Belknap, Steven M.

AU - McKoy, June M.

AU - Djulbegovic, Benjamin

AU - Edwards, Beatrice J.

AU - Weitzman, Sigmund A.

AU - Boyle, Simone

AU - Tallman, Martin S.

AU - Talpaz, Moshe

AU - Sartor, Oliver

AU - Bennett, Charles L.

PY - 2009/6/1

Y1 - 2009/6/1

N2 - Purpose: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P <0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P <0.05). Some key clinical information was discrepant between the two sources. Conclusions: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.

AB - Purpose: Serious adverse drug event (sADE) reporting to Institutional Review Boards (IRB) is essential to ensure pharmaceutical safety. However, the quality of these reports has not been studied. Safety reports are especially important for cancer drugs that receive accelerated Food and Drug Administration approval, like imatinib, as preapproval experience with these drugs is limited. We evaluated the quality, accuracy, and completeness of sADE reports submitted to an IRB. Experimental Design: sADE reports submitted to an IRB from 14 clinical trials with imatinib were reviewed. Structured case report forms, containing detailed clinical data fields and a validated causality assessment instrument, were developed. Two forms were generated for each ADE, the first populated with data abstracted from the IRB reports, and the second populated with data from the corresponding clinical record. Completeness and causality assessments were evaluated for each of the two sources, and then compared. Accuracy (concordance between sources) was also assessed. Results: Of 115 sADEs reported for 177 cancer patients to the IRB, overall completeness of adverse event descriptions was 2.4-fold greater for structured case report forms populated with information from the clinical record versus the corresponding forms from IRB reports (95.0% versus 40.3%, P <0.05). Information supporting causality assessments was recorded 3.5-fold more often in primary data sources versus IRB adverse event descriptions (93% versus 26%, P <0.05). Some key clinical information was discrepant between the two sources. Conclusions: The use of structured syndrome-specific case report forms could enhance the quality of reporting to IRBs, thereby improving the safety of pharmaceuticals administered to cancer patients.

UR - http://www.scopus.com/inward/record.url?scp=66649132782&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=66649132782&partnerID=8YFLogxK

U2 - 10.1158/1078-0432.CCR-08-1811

DO - 10.1158/1078-0432.CCR-08-1811

M3 - Article

C2 - 19458059

AN - SCOPUS:66649132782

VL - 15

SP - 3850

EP - 3855

JO - Clinical Cancer Research

JF - Clinical Cancer Research

SN - 1078-0432

IS - 11

ER -