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: OBJECTIVE
  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.
  
  
  METHODS
  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.
authors.affiliation: Oregon Health and Science University, Portland, Oregon, USA.
authors.forename: David A
authors.initials: DA
authors.lastname: Dorr
authors.forename: Rachel
authors.initials: R
authors.lastname: Burdon
authors.forename: Dennis P
authors.initials: DP
authors.lastname: West
authors.forename: Jennifer
authors.initials: J
authors.lastname: Lagman
authors.forename: Christina
authors.initials: C
authors.lastname: Georgopoulos
authors.forename: Steven M
authors.initials: SM
authors.lastname: Belknap
authors.forename: June M
authors.initials: JM
authors.lastname: McKoy
authors.forename: Benjamin
authors.initials: B
authors.lastname: Djulbegovic
authors.forename: Beatrice J
authors.initials: BJ
authors.lastname: Edwards
authors.forename: Sigmund A
authors.initials: SA
authors.lastname: Weitzman
authors.forename: Simone
authors.initials: S
authors.lastname: Boyle
authors.forename: Martin S
authors.initials: MS
authors.lastname: Tallman
authors.forename: Moshe
authors.initials: M
authors.lastname: Talpaz
authors.forename: Oliver
authors.initials: O
authors.lastname: Sartor
authors.forename: Charles L
authors.initials: CL
authors.lastname: Bennett
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration / Q000592:standards* / Q000706:statistics & numerical data*; D000970:Antineoplastic Agents / Q000009:adverse effects; D001549:Benzamides; D002986:Clinical Trials as Topic; D017723:Drug Utilization Review / Q000458:organization & administration / Q000592:standards / Q000706:statistics & numerical data; D050723:Fractures, Bone / Q000139:chemically induced; D006333:Heart Failure / Q000139:chemically induced; D006801:Humans; D000068877:Imatinib Mesylate; D007239:Infections / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy; D010879:Piperazines / Q000009:adverse effects; D011358:Product Surveillance, Postmarketing / Q000592:standards / Q000706:statistics & numerical data; D011367:Professional Staff Committees; D011654:Pulmonary Edema / Q000139:chemically induced; D011743:Pyrimidines / Q000009:adverse effects; D013997:Time Factors
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate