Completeness and effectiveness of reporting on three drugs: Lessons learned from RADAR, a novel pharmacosurveillance and pharmacovigilance program

Abstract

3201 Background: One objective of the Research on Adverse Drug reactions And Reports (RADAR) project is to analyze the comprehensiveness and clinical characteristics of ADRs submitted to FDA reports and the medical literature. Methods: Herein, we review our analysis of three drug-associated ADRS: Gemtuzumab ozogamicin (GO)-associated veno-occlusive disease (VOD), gemcitabine- associated interstitial pneumonitis and thalidomide-associated DVT/PE. RADAR analyzed the completeness of clinical trial (n=163) versus non-clinical trial (n=318) reports. Data was compared via Fisher's exact test, and the resulting p values were combined across drugs via Edgington's (1972) procedure. Results: Overall, clinical trial reports more often reported drug administration date, onset date and the number of days until ADR onset (p<0.0002 for all). Additionally, GO and Thalidomide clinical trial reports were more likely to report diagnostic testing (p<0.003) and GO was more likely to have drug dose and drug schedule (p< 0.001). In reviewing the clinical understanding of each ADR, RADAR highlighted the increased risk of prescribing HSCT with GO or various intensive concomitant chemotherapies with GO, thalidomide and gemcitabine. RADAR also found that three different monitoring strategies (GO-prospective study, Gemcitabine-volunatry reporting and Thalidomide-safety registry (STEPS)) were deficient, indicating that more diligent reporting is needed. Conclusions: RADAR advocates the creation of a consortium of adverse event monitoring programs at major clinical research centers to act as an early detection system for adverse drug reactions. No significant financial relationships to disclose.