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从申办者角度对医疗器械临床试验设计的思考

直播时间： 2018-01-11 17:00:00
  • 讲师介绍
  • 课程介绍
  • 大家在问 ()

  • 王烨

    爱尔康(ALC) 亚洲临床研发负责人

    讲课时间：0000-00-00 00:00:00

    医师，在临床试验、医学事务领域拥有18年工作经验，负责过心血管系统、电生理、人工关节、体外诊断试剂等多个领域。2010年至2014年在强生医疗器材有限公司任临床研究经理、高级临床研究经理。2014年4月起任圣犹达医疗用品（上海）有限公司临床副总监，2018年至今任爱尔康（Alcon）亚洲临床研发负责人。

课程介绍

【课程简介】 合理的方案设计是临床试验的基础，而作为申办者往往必须在有限的时间、有限的资源的情况下结合自身产品特点与监管要求制定方案，可选择的余地有限；如何在各种制约因素之下，充分发挥申办者的内在和外在优势，合理估计试验风险，配置试验资源，设计出科学、合理且具有可执行性的方案是申办者医学部工作的重点之一。本次讲座特邀研师王烨，根据器械临床试验方案的主要内容分享讲者在日常工作中对于方案设计经常遇到的困惑与困难，通过听众与讲者的讨论互动共同整理出一些基本的思路。同时，也会对方案设计的基本方法学问题进行探讨。精彩讲座，欢迎大家准时收看！

【目标受众】 医疗器械临床试验相关人员； 医疗机构临床研究负责人、机构管理人员； 合同研究机构（CRO）临床研究质量相关人员。

【您将收获】 了解医疗器械临床试验设计的方法学； 提升医疗器械临床试验设计的能力。

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    4. at Connection->statement('insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678')) in Connection.php line 398
    5. at Connection->insert('insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678')) in Builder.php line 2039
    6. at Builder->insert(array('payload' => 'YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', 'last_activity' => '1749778534', 'user_id' => null, 'ip_address' => '216.73.216.141', 'user_agent' => 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', 'id' => '0d89668406d6e15991592d0093382a727fc20678')) in DatabaseSessionHandler.php line 119
    7. at DatabaseSessionHandler->write('0d89668406d6e15991592d0093382a727fc20678', 'a:4:{s:6:"_token";s:40:"yzoapx5J7CzK2BYn5RHdcmJB2YcsTxFZfME5BjyI";s:9:"_previous";a:1:{s:3:"url";s:37:"https://www.51goodtrial.com/video/494";}s:9:"_sf2_meta";a:3:{s:1:"u";i:1749778534;s:1:"c";i:1749778534;s:1:"l";s:1:"0";}s:5:"flash";a:2:{s:3:"old";a:0:{}s:3:"new";a:0:{}}}') in Store.php line 262
    8. at Store->save() in StartSession.php line 88
    9. at StartSession->terminate(object(Request), object(Response)) in Kernel.php line 155
    10. at Kernel->terminate(object(Request), object(Response)) in index.php line 58

    1/2 PDOException in Connection.php line 441: SQLSTATE[HY000]: General error: 1290 The MySQL server is running with the LOCK_WRITE option so it cannot execute this statement

    1. in Connection.php line 441
    2. at PDOStatement->execute(array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678')) in Connection.php line 441
    3. at Connection->Illuminate\Database\{closure}(object(MySqlConnection), 'insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678')) in Connection.php line 706
    4. at Connection->runQueryCallback('insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678'), object(Closure)) in Connection.php line 669
    5. at Connection->run('insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678'), object(Closure)) in Connection.php line 442
    6. at Connection->statement('insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678')) in Connection.php line 398
    7. at Connection->insert('insert into `sessions` (`payload`, `last_activity`, `user_id`, `ip_address`, `user_agent`, `id`) values (?, ?, ?, ?, ?, ?)', array('YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', '1749778534', null, '216.73.216.141', 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', '0d89668406d6e15991592d0093382a727fc20678')) in Builder.php line 2039
    8. at Builder->insert(array('payload' => 'YTo0OntzOjY6Il90b2tlbiI7czo0MDoieXpvYXB4NUo3Q3pLMkJZbjVSSGRjbUpCMlljc1R4RlpmTUU1Qmp5SSI7czo5OiJfcHJldmlvdXMiO2E6MTp7czozOiJ1cmwiO3M6Mzc6Imh0dHBzOi8vd3d3LjUxZ29vZHRyaWFsLmNvbS92aWRlby80OTQiO31zOjk6Il9zZjJfbWV0YSI7YTozOntzOjE6InUiO2k6MTc0OTc3ODUzNDtzOjE6ImMiO2k6MTc0OTc3ODUzNDtzOjE6ImwiO3M6MToiMCI7fXM6NToiZmxhc2giO2E6Mjp7czozOiJvbGQiO2E6MDp7fXM6MzoibmV3IjthOjA6e319fQ==', 'last_activity' => '1749778534', 'user_id' => null, 'ip_address' => '216.73.216.141', 'user_agent' => 'Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)', 'id' => '0d89668406d6e15991592d0093382a727fc20678')) in DatabaseSessionHandler.php line 119
    9. at DatabaseSessionHandler->write('0d89668406d6e15991592d0093382a727fc20678', 'a:4:{s:6:"_token";s:40:"yzoapx5J7CzK2BYn5RHdcmJB2YcsTxFZfME5BjyI";s:9:"_previous";a:1:{s:3:"url";s:37:"https://www.51goodtrial.com/video/494";}s:9:"_sf2_meta";a:3:{s:1:"u";i:1749778534;s:1:"c";i:1749778534;s:1:"l";s:1:"0";}s:5:"flash";a:2:{s:3:"old";a:0:{}s:3:"new";a:0:{}}}') in Store.php line 262
    10. at Store->save() in StartSession.php line 88
    11. at StartSession->terminate(object(Request), object(Response)) in Kernel.php line 155
    12. at Kernel->terminate(object(Request), object(Response)) in index.php line 58