Reporting of serious adverse events during cancer clinical trials to the institutional review board

An evaluation by the research on adverse drug events and reports (RADAR) project

S. M. Belknap*, C. H. Georgopoulos, J. Lagman, S. A. Weitzman, L. Qualkenbush, P. R. Yarnold, B. J. Edwards, J. M. McKoy, S. M. Trifilio, D. P. West

*Corresponding author for this work

Research output: Contribution to journalReview article

4 Citations (Scopus)

Abstract

Global introspection is considered an unreliable method for attribution of causality of serious adverse events (SAEs), yet remains widely used for cancer drug clinical trials. Here, we compare structured case abstraction (SCA) to the routine method for detecting, evaluating, and reporting ADEs during cancer drug clinical trials to an Institutional Review Board (IRB). We obtained all SAE reports (2001.2008) received by one IRB for six clinical trials involving bevacizumab or oxaliplatin for treatment of gastrointestinal cancers. We compared the routine IRB SAE method to SCA for adverse event detection and causality attribution. Of 205 adverse events, 182 events (75%) were not reported; of these, 6 (20%) of 30 SAEs requiring an IRB report were unreported. For the 10 item Naranjo score, the amount of information useful for causality attribution was higher with SCA than the routine method (6.0 vs. 2.4 items, P.0001). One]fifth of SAEs requiring an IRB report were unreported to the IRB via the routine method. SCA provided more useful information as to whether an SAE was caused by a cancer drug exposure. Our results suggest that SCA may improve SAE detection and the accuracy of attribution of causality during cancer drug clinical trials.

Original languageEnglish (US)
Pages (from-to)1334-1340
Number of pages7
JournalJournal of Clinical Pharmacology
Volume53
Issue number12
DOIs
StatePublished - Dec 1 2013

Fingerprint

Research Ethics Committees
Drug-Related Side Effects and Adverse Reactions
Clinical Trials
Causality
Neoplasms
oxaliplatin
Pharmaceutical Preparations
Gastrointestinal Neoplasms

Keywords

  • Clinical pharmacology
  • Clinical trials
  • Drug information
  • Oncology
  • Outcomes research
  • Pharmacoepidemiology
  • Pharmacovigilance
  • Toxicology

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

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title = "Reporting of serious adverse events during cancer clinical trials to the institutional review board: An evaluation by the research on adverse drug events and reports (RADAR) project",
abstract = "Global introspection is considered an unreliable method for attribution of causality of serious adverse events (SAEs), yet remains widely used for cancer drug clinical trials. Here, we compare structured case abstraction (SCA) to the routine method for detecting, evaluating, and reporting ADEs during cancer drug clinical trials to an Institutional Review Board (IRB). We obtained all SAE reports (2001.2008) received by one IRB for six clinical trials involving bevacizumab or oxaliplatin for treatment of gastrointestinal cancers. We compared the routine IRB SAE method to SCA for adverse event detection and causality attribution. Of 205 adverse events, 182 events (75{\%}) were not reported; of these, 6 (20{\%}) of 30 SAEs requiring an IRB report were unreported. For the 10 item Naranjo score, the amount of information useful for causality attribution was higher with SCA than the routine method (6.0 vs. 2.4 items, P.0001). One]fifth of SAEs requiring an IRB report were unreported to the IRB via the routine method. SCA provided more useful information as to whether an SAE was caused by a cancer drug exposure. Our results suggest that SCA may improve SAE detection and the accuracy of attribution of causality during cancer drug clinical trials.",
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author = "Belknap, {S. M.} and Georgopoulos, {C. H.} and J. Lagman and Weitzman, {S. A.} and L. Qualkenbush and Yarnold, {P. R.} and Edwards, {B. J.} and McKoy, {J. M.} and Trifilio, {S. M.} and West, {D. P.}",
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Reporting of serious adverse events during cancer clinical trials to the institutional review board : An evaluation by the research on adverse drug events and reports (RADAR) project. / Belknap, S. M.; Georgopoulos, C. H.; Lagman, J.; Weitzman, S. A.; Qualkenbush, L.; Yarnold, P. R.; Edwards, B. J.; McKoy, J. M.; Trifilio, S. M.; West, D. P.

In: Journal of Clinical Pharmacology, Vol. 53, No. 12, 01.12.2013, p. 1334-1340.

Research output: Contribution to journalReview article

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T1 - Reporting of serious adverse events during cancer clinical trials to the institutional review board

T2 - An evaluation by the research on adverse drug events and reports (RADAR) project

AU - Belknap, S. M.

AU - Georgopoulos, C. H.

AU - Lagman, J.

AU - Weitzman, S. A.

AU - Qualkenbush, L.

AU - Yarnold, P. R.

AU - Edwards, B. J.

AU - McKoy, J. M.

AU - Trifilio, S. M.

AU - West, D. P.

PY - 2013/12/1

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N2 - Global introspection is considered an unreliable method for attribution of causality of serious adverse events (SAEs), yet remains widely used for cancer drug clinical trials. Here, we compare structured case abstraction (SCA) to the routine method for detecting, evaluating, and reporting ADEs during cancer drug clinical trials to an Institutional Review Board (IRB). We obtained all SAE reports (2001.2008) received by one IRB for six clinical trials involving bevacizumab or oxaliplatin for treatment of gastrointestinal cancers. We compared the routine IRB SAE method to SCA for adverse event detection and causality attribution. Of 205 adverse events, 182 events (75%) were not reported; of these, 6 (20%) of 30 SAEs requiring an IRB report were unreported. For the 10 item Naranjo score, the amount of information useful for causality attribution was higher with SCA than the routine method (6.0 vs. 2.4 items, P.0001). One]fifth of SAEs requiring an IRB report were unreported to the IRB via the routine method. SCA provided more useful information as to whether an SAE was caused by a cancer drug exposure. Our results suggest that SCA may improve SAE detection and the accuracy of attribution of causality during cancer drug clinical trials.

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KW - Clinical trials

KW - Drug information

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KW - Outcomes research

KW - Pharmacoepidemiology

KW - Pharmacovigilance

KW - Toxicology

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JO - Journal of Clinical Pharmacology

JF - Journal of Clinical Pharmacology

SN - 0091-2700

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