OBJECTIVES: The Weber effect, a peak in adverse event (AE) reporting of a drug at the end of second year and continuous decline thereafter, has been considered an important bias for a long time. The aim of this study was to analyze the temporal reporting patterns of fourteen drugs (approved in 2006) for ten years in FAERS database. METHODS: A retrospective analysis was executed on the fourteen drugs approved in 2006. The drugs were selected according to the following conditions. Drugs should be approved in 2006 so that the Adverse Event (AE) reports will be available for at least ten years and the drug should not have acclaimed any major safety alerts. Reports of all drugs were normalized for ease of analysis in such a way that the highest count in the reports of any of the 40 quadrants of the drug in question was considered as 100 and remaining count of reports of that particular drug was normalized accordingly. The reporting pattern were analyzed by quarterly and yearly basis. The data set for analysis was retrieved from FAERS database between 2006 and 2016. RESULTS: The analysis was performed by using 19,539 primary suspected reports associated with the fourteen drugs approved in 2006. Four different types of reporting patterns were observed on analysis according to quarterly basis, namely, transitory decline, plateau prior to the rise in AE reports resumes, Weber effect, M-type pattern. Significant Weber pattern was observed when the reports were analyzed yearly basis. CONCLUSIONS: The present analysis showed that FAERS reporting is pertinent to Weber effect. It is advisable to address Weber effect in all studies which utilize FAERS database and quantification of such effects are required as it may affect the results drawn from the database.OBJECTIVES: Immature survival data can result in higher uncertainty over longterm extrapolations, and consequently in decision-making. Such uncertainty can be reduced with the use of external data. We aimed to review the use of external data to better inform survival extrapolations in submissions to the National Institute for Health and Care Excellence (NICE). METHODS: All NICE technology appraisals (TAs) that dealt with any stage of cancer and had been completed after December 2001 were reviewed. All relevant documents available on the NICE website were reviewed with special attention to the reports developed by the independent Assessment Group (AG) or Evidence Review Group (ERG). We included TAs where external data was used to inform survival extrapolations. Then, in addition to general information about the TA, we extracted the following information: external data source (historical trial, registry data or general population mortality), methods explored in the sponsor submission, criticism and alternative scenarios proposed by AG or ERG. RESULTS: Out of 143 reviewed TAs, ten TAs reported the use of external data to quantitatively inform survival extrapolations. These TAs were in two indications: melanoma (n¼8) and chronic lymphocytic leukemia (n¼2). Most frequently, a m...

cardiovascular, and rare diseases), and (b) further subdivide the publications identified by type of study (pragmatic, observational, database, registry, and other). RESULTS: The initial broad search revealed that cancer had the most publications, with a total of 1,030,609 hits, followed by cardiovascular at 395,848, and rare diseases with 91,356. In 2017, of the total publications across the three disease areas, only 0.35% (881/245,575) utilized RWE, and cardiovascular was more likely than cancer or rare diseases to feature RWE in publications (2017: 0.58% vs. 0.29% vs. 0.24%). When considering study types utilizing RWE over the period searched, the most common type for each disease area varied broadly; database was the highest for cancer, observational for rare diseases, and registry for cardiovascular. Year-on-year analysis revealed that publications utilizing RWE became more frequent across the three disease areas between 2012 and present. CONCLUSIONS: Across all three disease areas, RWE publication over time was consistent or increasing. The number of papers reporting RWE remains low, which may be reflective of the lack of guidelines for reporting, and variability in the definition of RWE. Further consensus would aid the acceptance of RWE as supportive evidence.