澳门第一赌城在线娱乐对临床试验透明度的承诺
作为一家以科学为主导的澳门第一赌城在线娱乐公司, our clinical research is crucial to the development of potentially innovative and life-changing medicines and vaccines we aim to deliver to the people who need them most.
People who volunteer to participate in clinical trials are generously sharing their time and experience with the aim of helping to better advance treatments for everyone. This is why we are deeply committed to their safety and to maintaining the highest standards of conduct across all our clinical trials.
We firmly believe that being transparent about our research and development allows other researchers to access the data, as well as serving the best interests of the people and patients who use our medicines.
道德和公开地工作
澳门第一赌城在线娱乐于2005年确立了对临床试验透明度的承诺, making information about our clinical research publicly available on our dedicated website astrazenecaclinicaltrials.com. We are also committed to disclosing our trial summary data on external public registries such as 临床试验.政府 和 欧盟临床试验注册.
It is important we respect and uphold the principles developed by world 健康 and regulatory organisations, 以及整个制药行业的临床试验. 这些包括 赫尔辛基宣言, 负责任的临床试验数据共享原则 和 国际药品制造商联合会 & 负责任临床试验数据共享的协会原则. All our clinical trial transparency policies meet industry standards while ensuring patient 隐私 and trial 完整性.
We publish results from all our clinical trials on public registries such as 临床试验.政府和EU临床试验注册, 以及同行评议的医学和科学期刊, 不管结果如何都要支持科学进步. We also publish easy to understand clinical Trial Result Summaries for study participants 和 general public for at www.trialsummaries.com. AstraZeneca also has a long standing history of sharing anonymised individual patient level data with qualified researchers from trials of approved products in the US and EU, 支持澳门第一赌城在线娱乐对…的承诺 负责任临床试验数据共享原则.
生物伦理学 is also a central component of our commitment to transparency in the way we conduct our biological and medical research 和 care we take to act ethically and in full compliance of external regulations.
保持审判的完整性
Good Clinical Practice (GCP) and regulatory standards dictate the tight control of information around a clinical trial. 审判还在进行中, 某些细节必须保密, 以保证审判的公正性. This is absolutely vital because the uncontrolled or premature release of information by researchers could inadvertently influence or bias the outcome of the trial, 从而使结果无法解释.
Many trials are ‘randomised’ which means study participants are randomly assigned into either a group receiving the investigatory medicine or a control group, 也被称为安慰剂组. A ‘blinded’ trial means a participant does not know if they are receiving the investigatory medicine or a placebo. And a ‘double-blind’ clinical trial is where neither the participant nor the investigator knows if the participant is receiving the investigatory medicine. Blinding is an important component of many clinical trials to ensure that a subject’s knowledge of what treatment they have been assigned does not influence how they respond to emerging symptoms, 危及审判的有效性.
的 safety and efficacy of a medicine is continually being assessed against the entirety of all data collated for a medicine under development. Any potential signal that changes the overall benefit-risk profile of the medicine, as judged by the researchers and regulators may lead to modifying the study design, 新型安全监测, 停止研究, 或者可能加快审批.
以确保在澳门第一赌城在线娱乐的临床试验过程中的安全监督, 一个独立的临床专家小组, unrelated to the the trial is responsible for reviewing ongoing safety reports. 此外, 整个研究的安全性可以由外部, independent Data and Safety Monitoring Board (DSMB) responsible for monitoring patient safety and treatment efficacy data while a clinical trial is ongoing. Any new serious and unexpected events are immediately reported to 健康 authorities, 以及在试验现场的调查人员, 并在知情同意书中向所有试验参与者报告, 在适当的时候.
病人是澳门第一赌城在线娱乐研究的核心
的 赫尔辛基宣言 clearly states: ‘It is the duty of physicians who are involved in medical research to protect the life, 健康, 尊严, 完整性, 自决权, 隐私, 对研究对象的个人信息保密.’
In an ongoing trial it is important that trial investigators and participants have relevant anonymised information shared with them in order for that medical research to progress to its full potential, 同时也符合公众健康的最大利益.
Safety data is always made public once every trial for the investigatory medicine has been completed. 经卫生主管部门批准的新药, 适当地提供患者信息, 简单的语言和营销产品. 作为继续销售澳门第一赌城在线娱乐药品的要求, we also commit to ongoing safety monitoring post marketing authorisation and keeping the Product Information up-to-date with any new information relating to the safe and effective use of our products.
