新冠疫情第三个年头,我们整个行业正面临前所未有的挑战,在全球: 大约 80% 的非 COVID-19 试验被停止或中断。 截至 2021 年 1 月,COVID-19 已迫使 2,000 多项临床试验停滞。 63% 的研究中心禁止现场监查访视,24% 的研究者出于患者安全考虑而停止了新的受试者招募/入组。 As the Covid-19 pandemic enters its third year,we are deeply grateful to all those who have chosen a career in clinical research. You help advance science and medicine in ways that improve the lives of people and communities throughout the world. This year, we honor clinical trials professionals who are going to great lengths to help patients and colleagues in the face of extraordinary adversity. Your resilience and commitment are an inspiration as we press to overcome challenges that put people at risk today and delay the development of life-saving medicines for tomorrow. 新冠疫情进入第三个年头,我们非常感谢所有选择从事临床研究的人。他们正以改善全世界人民和社区生活的方式帮助推进科学和医学。 今年,我们向临床试验专业人士致敬,他们在面对异常逆境时不遗余力地帮助患者和同事。疫情当下,当我们努力克服使人们今天处于危险之中并延迟未来拯救生命药物的开发时,您的韧性和承诺是一种鼓舞。 Without volunteers, there would be no clinical trials. And without the thousands of people who have chosen a career in clinical research, it would not be possible to turn scientific discoveries into new medicines and vaccines. That's why it's so important that we get it right. 没有志愿者,就没有临床试验。如果没有成千上万的人选择从事临床研究,就不可能将科学发现转化为新药和疫苗。这就是为什么我们把它做对如此重要。 寄望临床试验的未来转变! Look forward to the future transformation of clinical trials! Clinical trial diversity and inclusion: We believe everyone should have the opportunity to participate in clinical trials, especially those whose communities are often under-represented. We’re designing and conducting our studies to reflect the true diversity of our patients and partnering with stakeholders from local communities to support inclusion in our clinical trials. 临床试验的多样性和包容性:我们相信每个人都应该有机会参与临床试验,尤其是那些被主流社会忽视的人群。我们正在设计和开展足以反映我们患者的真正多样性的临床试验,我们将和当地社区的利益相关者合作,以支持将被主流忽视的人群纳入我们的临床试验。 New voices in protocols: Patients know their disease better than anyone, and the people who run our protocols have unique insights into what works well. That's why we're convening advisory panels: it helps us ensure patients and sites can contribute meaningfully to improving our study designs. 方案中的新声音:患者比任何人都更了解自己的疾病,而执行我们方案的人对如何更好实施具有独特的见解。这就是未来方案设计时需要组建咨询小组的原因:它帮助我们确保患者和研究中心能够为改进我们的研究设计做出有意义的贡献。 User-friendly technology: We're making it simpler for people to participate remotely by incorporating wearables and other smart devices in our study designs. In fact, all new phase 2 and phase 3 clinical studies now require a remote component to support decentralized clinical trials in the future. We're also need to roll out virtual trainings and meetings to better support knowledge and experience exchange between sites and regions. 用户友好的技术:通过在我们的研究设计中加入可穿戴设备和其他智能设备,让人们更容易远程参与。事实上,未来所有新的 2 期和 3 期临床研究现在都需要一个远程组件来支持去中心化临床试验。我们还需要推出了虚拟培训和会议,以更好地支持不同区域研究中心之间的经验和知识交流。 Offer more Suppor to our sites: We know our sites are under tremendous pressure during Covid-19 pandemic, so we're simplifying processes and making sure that the people who run our trials feel supported. Our Site Partnership Managers cover all regions, so there is a clear point of contact and support for study sites both before and during a clinical trial. Our streamlined data entry, query resolution, monitoring, contracting, and payment processes let sites spend more time on patient management and care. 为研究中心提供更多:在新冠疫情肆虐期间,我们知道我们的研究中心承受着巨大的压力,因此我们需要简化所开展临床试验的流程并确保给研究中心成员提供有效支持。去中心化人员派驻,这样我们的临床试验实施人员能覆盖所有参研中心所在的地区,在临床试验启动前和研究期间都能给研究中心提供实实在在的点对点支持。我们简化的数据输入、数据差异解决、临床监查、合同谈判和研究费用付款流程让研究中心人员可以将更多时间用于患者管理和护理。 We are humbled by the commitment and dedication of clinical trial site staff, even in the face of adversity. And we are deeply grateful, every day, for the many patients and healthy volunteers whose participation makes new medicines and vaccines possible. 即使面对逆境,临床试验现场工作人员的承诺和奉献精神也让我们感到谦卑。我们每天都非常感谢许多患者和健康志愿者的参与,他们的参与使新药和疫苗成为可能。 |