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• W3149969615 abstract "An accurate and comprehensive assessment of harms is a fundamental part of an accurate weighing of benefits and harms of an intervention when making treatment decisions; however, harms are known to be underreported in journal publications. Therefore, we sought to compare the completeness of reporting of harm data, discrepancies in harm data reported, and the delay to access results of oncological clinical trials between three sources: clinical study reports (CSRs), clinical trial registries and journal publications.We used the EMA clinical data website to identify all trials submitted to the EMA between 2015 and 2018. We retrieved all CSRs and included all phase II, II/III or III randomised controlled trials (RCTs) assessing targeted therapy and immunotherapy for cancer. We then identified related records in clinical trial registries and journals. We extracted harms data for eight pre-specified variables and determined the completeness of reporting of harm data in each of the three sources.We identified 42 RCTs evaluating 13 different drugs. Results were available on the EMA website in CSRs for 37 (88%) RCTs, ClinicalTrials.gov for 36 (86%), the European Clinical Trials Register (EUCTR) for 20 (48%) and in journal publications for 32 (76%). Harms reporting was more complete in CSRs than other sources. We identified marked discrepancies in harms data between sources, e.g. the number of patients discontinuing due to adverse events differed in CSRs and clinical trial registers for 88% of trials with data in both sources. For CSRs and publications, the corresponding number was 90%. The median (interquartile range) delay between the primary trial completion date and access to results was 4.34 (3.09-7.22) years for CSRs, 2.94 (1.16-4.52) years for ClinicalTrials.gov, 5.39 (4.18-7.33) years for EUCTR and 2.15 (0.64-5.04) years for publications.Harms of recently approved oncological drugs were reported more frequently and in more detail in CSRs than in trial registries and journal publications. Systematic reviews seeking to address harms of oncological treatments should ideally use CSRs as the primary source of data; however, due to problems with access, this is currently not feasible." @default.
• W3149969615 created "2021-04-13" @default.
• W3149969615 creator A5000301171 @default.
• W3149969615 creator A5065028933 @default.
• W3149969615 creator A5073880770 @default.
• W3149969615 date "2021-04-08" @default.
• W3149969615 modified "2023-10-09" @default.
• W3149969615 title "Reporting of harms in oncological clinical study reports submitted to the European Medicines Agency compared to trial registries and publications—a methodological review" @default.
• W3149969615 cites W1936739249 @default.
• W3149969615 cites W1966406045 @default.
• W3149969615 cites W1967792499 @default.
• W3149969615 cites W1968384808 @default.
• W3149969615 cites W1971142107 @default.
• W3149969615 cites W1986360186 @default.
• W3149969615 cites W2002062153 @default.
• W3149969615 cites W2002770029 @default.
• W3149969615 cites W2013768132 @default.
• W3149969615 cites W2023187985 @default.
• W3149969615 cites W2036062818 @default.
• W3149969615 cites W2041055583 @default.
• W3149969615 cites W2051457518 @default.
• W3149969615 cites W2064223985 @default.
• W3149969615 cites W2079763503 @default.
• W3149969615 cites W2091139031 @default.
• W3149969615 cites W2100912832 @default.
• W3149969615 cites W2104347254 @default.
• W3149969615 cites W2106952837 @default.
• W3149969615 cites W2109240520 @default.
• W3149969615 cites W2111662961 @default.
• W3149969615 cites W2112658951 @default.
• W3149969615 cites W2122956665 @default.
• W3149969615 cites W2128758225 @default.
• W3149969615 cites W2132870547 @default.
• W3149969615 cites W2137043950 @default.
• W3149969615 cites W2139804581 @default.
• W3149969615 cites W2152376701 @default.
• W3149969615 cites W2152897456 @default.
• W3149969615 cites W2152905269 @default.
• W3149969615 cites W2155338842 @default.
• W3149969615 cites W2160959204 @default.
• W3149969615 cites W2165630767 @default.
• W3149969615 cites W2166662937 @default.
• W3149969615 cites W2167934111 @default.
• W3149969615 cites W2171139285 @default.
• W3149969615 cites W2198093519 @default.
• W3149969615 cites W2209368665 @default.
• W3149969615 cites W2222086386 @default.
• W3149969615 cites W2232632307 @default.
• W3149969615 cites W2237254160 @default.
• W3149969615 cites W2268267848 @default.
• W3149969615 cites W2270702517 @default.
• W3149969615 cites W2293618284 @default.
• W3149969615 cites W2313479654 @default.
• W3149969615 cites W2339850880 @default.
• W3149969615 cites W2341586961 @default.
• W3149969615 cites W2412074196 @default.
• W3149969615 cites W2415125269 @default.
• W3149969615 cites W2415950182 @default.
• W3149969615 cites W2471050799 @default.
• W3149969615 cites W2474699717 @default.
• W3149969615 cites W2508537271 @default.
• W3149969615 cites W2511112097 @default.
• W3149969615 cites W2512922897 @default.
• W3149969615 cites W2519279652 @default.
• W3149969615 cites W2523042213 @default.
• W3149969615 cites W2527905628 @default.
• W3149969615 cites W2550378266 @default.
• W3149969615 cites W2552099557 @default.
• W3149969615 cites W2589693271 @default.
• W3149969615 cites W2593338436 @default.
• W3149969615 cites W2606976048 @default.
• W3149969615 cites W2612399534 @default.
• W3149969615 cites W2636042323 @default.
• W3149969615 cites W2719623628 @default.
• W3149969615 cites W2735625431 @default.
• W3149969615 cites W2736563947 @default.
• W3149969615 cites W2747107882 @default.
• W3149969615 cites W2748154165 @default.
• W3149969615 cites W2753432434 @default.
• W3149969615 cites W2757450081 @default.
• W3149969615 cites W2763004155 @default.
• W3149969615 cites W2765867855 @default.
• W3149969615 cites W2767287110 @default.
• W3149969615 cites W2773155010 @default.
• W3149969615 cites W2782594419 @default.
• W3149969615 cites W2783341375 @default.
• W3149969615 cites W2785885859 @default.
• W3149969615 cites W2787358630 @default.
• W3149969615 cites W2791840917 @default.
• W3149969615 cites W2794061572 @default.
• W3149969615 cites W2808333976 @default.
• W3149969615 cites W2885102792 @default.
• W3149969615 cites W2885475459 @default.
• W3149969615 cites W2886464002 @default.
• W3149969615 cites W2896600825 @default.
• W3149969615 cites W2896846857 @default.
• W3149969615 cites W2897693137 @default.
• W3149969615 cites W2898684787 @default.
• W3149969615 cites W2901553335 @default.
• W3149969615 cites W2902212622 @default.

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