George Clinical teams draw on proven working models, established global relationships and unflinching dedication to implement clinical trial in a matter of weeks.
In the dark times of global COVID-19 lockdowns, scientists and healthcare workers pressed forward in their mission of caring for and protecting the sick, particularly those who were contracting COVID-19. The global George Clinical team was no exception and was challenged with embarking on a clinical trial to investigate the potential of a drug to give certain COVID-19 patients a better chance of survival. As with all trials associated with the virus, timing was critical, resources were limited, healthcare systems around the world were over-taxed and virtually everyone except frontline workers were confined to their homes and completely dependent on electronic communications. Despite these adverse conditions, the George Clinical team hit the ground running, and was able to begin recruiting patients in warp speed time.
“This study was set up and started recruiting in record time which, honestly in my seventeen years in this industry I have never seen and couldn’t actually imagine being possible. Taking into account all the challenges we met on the road to this I was a bit skeptical about the possibility of recruiting the required number of patients in 2020, but at the moment we have completed two-thirds of the recruitment and the potential is actually growing and I’m optimistic,” said Andrejs Faibusevics, project manager.
Long-standing operational model proves valuable under extreme pressures of pandemic.
Our longstanding “Science. Services. Solutions.” model of operations proved to be particularly suited to getting things done faster under these extreme conditions. The scientific team researched the most up to date COVID-19 information to best design the study for maximum results in the shortest period of time. The operations team used their experience in generating creative solutions and forming excellent, effective communication pathways between all involved parties across time zones and continents. The team was able to develop solutions to the many uncommon barriers in order to expedite and optimize the conduct of the study.
Extremely tight timelines, all-remote communications, multiple continents, lack of clinical researchers in COVID-19 critical hospitals and the challenges of working from home during lockdown periods.
As this study was designed to develop a major COVID-19 solution, the timing was extremely critical — the faster the better. Many of the countries that George Clinical is conducting the trial, such as Brazil, India, Mexico and Argentina typically take months and face-to-face meetings in order to obtain the required approval. This was an unacceptable timeframe in these critical times of global pandemic. Our team was able to shorten the startup timelines to unheard of levels in multiple countries and was able to get approval within a matter of weeks to begin enrolling patients at the height of the pandemic.
Apart from the regulatory issues, it was also imperative to engage hospital researchers who were not able to be in their respective hospitals due to lockdown restrictions and to also find the most effective way to communicate with the healthcare workers actually caring for the COVID-19 patients who could eventually be enrolled in the study. Team members understood that these professionals were equally challenged and stressed and worked diligently to ensure that communications were as convenient and efficient as possible for these individuals.
“It was critical that George Clinical has developed relationships in a variety of countries, and we were able to leverage those to quickly assess the situation on the ground. And with the revised regulatory timeline, George Clinical’s global network/peer to peer model was a plus because we could make appropriate strategic decisions with communications already in place and an understanding/familiarity with regulations and the specific requirements of the different countries. It’s exciting to us to be able to do things in a little bit different, less bureaucratic way in order to get the trial to the patients quickly,” said Emily Akin, project director.
Having our scientific leaders at the helm of this project certainly expedited the approval process. They were able to identify the best sites for the study in their respective countries and gain regulatory intelligence on the ground in terms of which physicians at COVID hospitals could potentially enroll the most patients. They understood what the intent behind the regulations were and how to meet those intents in creative ways to ensure that the trial retained good scientific rigor and safety for patients. Through many protocol amendments and changes to process, their quick strategic decisions based on the best science and their knowledge of what regulators are looking for were crucial factors in getting the study underway so quickly.
But it is really the willingness of every person on this team that ultimately got the job done. They were driven by the possibility of giving certain patients a higher potential of survival after they contracted the COVID-19 virus. It’s taken incredibly hard work from every member of the team and very long hours to react to all the modifications and to deliver and continue to deliver the solutions that are needed for the trial. Despite working with lockdown issues — children who were being home-schooled and needing attention and computer time — elderly parents who needed looking after — having a first baby — being quarantined within their home waiting for a COVID test — they were all facing the same unique challenges in their personal lives as the rest of us and still never wavered in their dedication and determination to get this major COVID-19 study up and running.
“As CMO of George Clinical I am extremely proud of this team and the work they have accomplished in these extraordinary times. As Emily stated “I can’t tell you how challenging this is. Every day is deadline day and you get up and choose to fight, and there are days you don’t feel like fighting anymore but you do it anyway.” And as unusual as these circumstances have been, this behavior and “can do no matter what” attitude is not at all unusual for a George Clinical team. Our people are absolutely our best asset because each and every one is invested in their business in a very personal way. Every team member is willing to be as flexible, creative and available as the job requires. And we all at George Clinical are constantly and consistently working toward the goal of improving the health and quality of life of as many people in as many places as possible, trial by trial, treatment by treatment, patient by patient,” stated Chief Medical Officer Maria Ali.