{"id":1760,"date":"2017-01-04T12:27:25","date_gmt":"2017-01-04T12:27:25","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1760"},"modified":"2021-10-12T11:34:36","modified_gmt":"2021-10-12T06:04:36","slug":"the-snippet-fatal-french-clinical-trial-failed-to-check-data-before-raising-drug-dose","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/the-snippet-fatal-french-clinical-trial-failed-to-check-data-before-raising-drug-dose","title":{"rendered":"Fatal French clinical trial failed to check data before raising dose"},"content":{"rendered":"<p style=\"text-align: justify;\">Criticism of the drug company at the centre of a disastrous clinical trial that left one participant dead and four with long-term neurological symptoms has intensified following a revelation that the firm did not use certain data when deciding to administer a higher dose that proved deadly. On 15 December, during a conference presentation by a scientist from the Portuguese company, Bial, it emerged that the firm did not use certain readings, called pharmacodynamic (PD) data, on how the drug BIA 10-2474 was acting in participants who had received a lower dose, before taking the decision to increase the dosage. When asked why the company had not included the PD data in its dose-escalation decision, Helena Gama, head of Bial\u2019s pharmacovigilance and drug safety office said, \u201cThe evaluation before starting a new drug escalation is based on safety evaluation and pharmacokinetic data\u201d \u2014 referring to other data on how the drug is absorbed, distributed, metabolized and excreted by the body. \u201cWe did not have any profile that precluded the path to the further dosage.\u201d<\/p>\n<p style=\"text-align: justify;\">To read more, click <a href=\"http:\/\/www.nature.com\/news\/fatal-french-clinical-trial-failed-to-check-data-before-raising-drug-dose-1.21190\">French clinical triail irregularities<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Criticism of the drug company at the centre of a disastrous clinical trial that left one participant dead and four with long-term neurological symptoms has intensified following a revelation that the firm did not use certain data when deciding to administer a higher dose that proved deadly. On 15 December, during a conference presentation by [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1761,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[41],"tags":[168,634,733,712,732],"industry":[17225],"therapeutic_areas":[17229],"class_list":["post-1760","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-snippets","tag-clinical-trial","tag-drug-development","tag-increased-drug-dose","tag-pharma-industry","tag-trial-related-death","industry-pharmaceutical","therapeutic_areas-central-nervous-system"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO 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