景helped to launch a COVID-19 study in a record-breaking 14 business days, as discussed in an早些时候的文章– but what happened next? We followed up with some of the Covance employees who are helping to advance a small U.S. biotech’s clinical trial to its next phases and study a unique antiviral drug that could help patients and change the course of the COVID-19 pandemic.
On a Sunday morning, Jim received an unexpected text message, inviting him to dial into a meeting later that afternoon to discuss work with a new client. He joined the call and immediately started to support the project as principal investigator for the study.
Principal Investigator
Leeds, U.K.
“The pace in the clinic continues to be extremely rapid,” explained Jim. “We have worked on bank holidays and weekends to achieve – in six weeks – progress that would normally take six months in order to get the drug to the point where it can be assessed in patients.”
Despite the personal sacrifice of spending so many working hours on the study, Jim also feels privileged to be involved.
“A lot of our staff have dedicated their time to keep the study moving so quickly. People, including our healthy volunteers who are leaving the safety of their homes to help us advance this study, are really excited to be involved with developing a drug that could be used to treat the novel coronavirus. From the recruitment, study conduct and planning teams, to the pharmacy and project management departments, to the safety lab and our bioanalytics and pharmacokinetics (PK) teams, this is a great example of our collaborative efforts and the power of our combined enterprise.”
When the medical writing team was given the opportunity to support the Phase I study protocol for the biotech company, Mark and his colleagues were happy to help. The team worked together to continue addressing current projects while Mark and other medical writers devoted substantial effort to the client on short notice. To accelerate the process, two writers worked on the same protocol, authoring different sections.
高级医疗作家
Leeds, U.K.
“在短短的一天，我们制定了一个草案，”马克说。“然后，在接下来的两周内，我们写了四次修正案，甚至支持知情同意书（ICF）的写作。每个人都想在目前的大流行中做他们的一部分，涉及到全球各地的每个人至关重要的东西感觉很好。“
Mark has also seen the support of his team and manager throughout this project.
“From people at the clinic, to the clinical operations team and the project managers, everyone is there to support each other. For us, this work is not just a job, but a profession where we have pride in the work we do.”
Before data had even been generated from the study, Anjali’s data management team in Bangalore, India was working closely with the team in Leeds, U.K. to create a plan for quickly validating and analyzing the trial data.
经理，临床数据管理
Bangalore, India
“我们在编程，生物统计学和医疗队伍中与不同的利益相关者合作，以确保我们与数据提交的标准保持一致，并满足时间表。作为我们的第一个Covid-19研究，我们希望有效地计划和执行，尽快提供结果，并继续实现我们改善健康和改善生活的使命。“
距离其他利益相关者的远程和地理位置，其中一个Anjali的团队成员确定如何处理与客户协议对齐的数据，遵守法规要求，并在短短两周内符合数据库构建的严格时间表 - 而不会影响质量。
“这项研究的Biotech公司的牵头数据审查员表示，他从未见过不同的全球部门的合作，”Anjali说。“大流行可能是世界各地的，但人们也可以努力对抗这种病毒。我们都希望这种治疗成功地击败病毒并使世界成为更安全和更健康的地方。“
随着参与者在学习阶段注册，克里斯和他的团队提供现场监测，确保遵守议定书，只有符合条件的参与者注册。
Senior CRA
Leeds, U.K.
“I quite like my job and love working in Phase I development,” said Chris. “With this COVID-19 project, we have smashed our own record to reach First-in-Human, which usually takes months – not just 14 business days (if you don’t count the weekends that many people worked over). CRAs [clinical research associates] are in a unique position as we work across every team in the research unit (and those based outside the unit), and it is interesting to see a study from the start of the protocol and work onsite with site staff and doctors.”
克里斯还认识到球队工作的潜在影响。“如果这种治疗可以有所帮助，那么有效的抗病毒毒率并没有太多的有效抗病毒药人。超越Covid-19，人们仍然诊断。我们的团队将始终参与这项基本作品来帮助治疗患者环境。“
ANA.’s work as a screening technician represents the most “hands-on” role of working directly with participants on the COVID-19 study.
Screening Technician
Leeds, U.K.
“With the pandemic, we have put many social distancing practices into place to keep everyone healthy. Our team first confirms whether our healthy volunteers have been potentially exposed to the virus; we then explain our consent form, take their vitals, like blood pressure and temperature, and perform an electrocardiogram and run blood work.”
The environment is challenging, but Ana recognizes the value of her role, which also includes tracking progress and archiving.
“We are always in contact with the doctors and making sure we are thoroughly evaluating each study participant. It has been hard work with long hours, but we all work as a team and hope our efforts will help change this global situation.”
凯西可以被认为是一个“连接器”，谁在适当的时候带入合适的人来支持这个快节奏的项目。
战略和规划高级总监
Charlotte, North Carolina, USA
“作为分子开发团队的一部分，我帮助提出了特定的主题专业知识，以便我们可以帮助生物技术公司从I阶段进行批准。我们努力支持他们的试验设计，确定样本大小，看看我们如何快速前进，“她解释说。
She also stressed the need to be flexible and adapt quickly to change. “The global regulatory landscape is quickly adjusting to support COVID-19 studies and we have to ensure that we can quickly respond.”
“The work can be stressful at times,” admits Casey, “but it is ultimately enjoyable. It’s why we chose to go into clinical research. We are really trying to impact patients’ lives, and it’s great knowing you have a direct effect on people.”
这篇文章只涵盖体育的一小部分ople who continue to work tirelessly to ensure patient safety and advance the treatment through the clinic. The team embodies the energizing purpose of our work and our dedication to our mission to improve health and improve lives. As work on this COVID-19 trial and other projects grow, we will continue to highlight our people and their important roles in helping to advance assays, vaccines and novel therapies that will make a difference in the fight against COVID-19.
To hear more from our exceptional people and learn how they are helping to solve drug development challenges and transform ideas into reality for patients,点击这里.
