DESCRIPTION (provided by applicant): Assessments of barriers to dissemination of serious adverse drug reaction (sADR) information are important for patient safety. Timely information dissemination on sADRs is important for oncology drugs, as they are toxic to normal and malignant cells, have high sADR rates, and often receive accelerated approval and/or priority review. Recently, the Food and Drug Administration (FDA) has approved tyrosine kinase inhibitors (TKIs), an important novel drug class administered for chronic mylogenous leukemia, gastrointestinal stromal tumors, renal cell cancers, and hepatocellular carcinoma. One concern is that drugs that receive accelerated approval or priority review are associated with sADRs not reported in a timely manner. Our objective is to develop the Southern Oncology Network on Adverse Reactions (SONAR) to evaluate sADRs for TKIs and DECREASE the duration of time between sADR identification and FDA/sponsor actions. The work builds on our identification of 50 sADRs, our sub-award from ERG assisting FDA's Center for Drug Evaluation and Research, our collaboration with former Connecticut Attorney General Richard Blumenthal that decreased the time-lag between thalidomide-sADR identification and sponsor/FDA safety-actions by several years, and FDA interest in TKI-associated cardiotoxicity. Our prior work, supported by five R01s, led to major publications, "Black Box" warnings, "Dear Doctor" letters, and changes in use of block-buster pharmaceuticals (e.g. erythropoietin/darbepoetin). Our aims are to: identify, evaluate, and report case information for TKI-associated cardiotoxicity and other sADRs; identify factors associated with shorter time periods for identification/dissemination of sADR information; develop a novel approach to streamlining sADR information dissemination (building on our successful pilot effort); and participate in a FDA initiative that will link molecular toxic
target studies (basic science) and organ-level toxicity (clinical science), with TKI-associated cardiotoxicity being the first area of study. We will disseminate brief reports for 25 to 50 TKI-associated sADRs and "Citizen's Petitions" to the FDA for sADRS for which our consultants identify as candidates for "Black Box" warnings or "Dear Doctor" letters (translating research into policy). The second component will be hypothesis driven, identifying factors associated with delayed sADR identification/reporting. The proposed innovative study will be the first to systematically attempt to shorten the six to seven year time lag between identification and reporting of oncology drug- associated sADRs and the first collaboration that provides information for FDA-led investigation of biologic and clinical aspects of a sADR involving an entire drug class.
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