Meet the People Advancing an Accelerated COVID-19 Clinical Trial

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.

“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 teams, study conduct and planning teams, the pharmacy and project management, 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.

“In just one day, we had developed a draft,” said Mark. “Then, over the next two weeks we wrote four amendments and even supported writing for the Informed Consent Form (ICF). Everyone wants to do their part in the current pandemic, and it feels good to be involved in something that is so critical for everyone around the globe.”

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.

“We collaborated with different stakeholders in the programming, biostatistics and medical writing teams to ensure we were aligning with the standards for data submission and meeting the timelines. As our first COVID-19 study, we wanted to plan and execute efficiently, deliver the results as soon as possible and continue to achieve our mission of improving health and improving lives.”

Working remotely and across geographies with other stakeholders, one of Anjali’s team members determined how to handle the data to align with the client’s protocol, adhere to the regulatory requirements and meet the stringent timelines of a database build in just two weeks – without compromising quality.

“The lead data reviewer was impressed with the urgency of approach and seamless collaboration across different global departments,” said Anjali. “The pandemic may be all around the world, but so are the people ready to fight this virus. We all hope this treatment succeeds in its purpose of defeating the virus and making the world a safer and healthier place.”

As participants enroll in the Phase I study, Chris and his team provide onsite monitoring, ensuring the protocol is followed and only eligible participants are enrolled.

“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.”

Chris also recognizes the potential impact of the team’s work. “There aren’t too many effective antivirals, and it would be great if this treatment can help. Beyond COVID-19, people are still getting other diagnoses. Our team will always be involved in this essential work to help get a treatment into the patient setting.”

Ana’s work as a screening technician represents the most “hands-on” role of working directly with participants on the COVID-19 study.

“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.”

Casey can be thought of as a “connector” who works to bring in the right people at the right time to support this fast-paced project.

“As part of the molecule development team, I have helped bring in particular subject matter expertise so we can help the biotech company progress from Phase I to approval. We have worked to support their trial design, determine sample sizes and see how we can quickly move forward,” she explained.

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.”