No patient left behind in our clinical trials
We’re here for patients when they need us most
June 29, 2020
In the midst of a pandemic, our clinical trials team went through great lengths – including a canoe ride and a 10-hour road trip – to ensure that our clinical trials for approximately 37,000 patients worldwide would continue without interruption and with a high degree of safety, quality and compliance. Clinical trials are a cornerstone of the discovery and development process that brings new medicines and vaccines from research labs to patients and customers who need them. They are a complex undertaking during routine circumstances. Maintaining continuity of more than 250 clinical trials during a pandemic required dedication and quick action to ensure that no patient would be left behind.
To conduct these trials, we depend on not only the many nurses, clinical research coordinators and medical practitioners, but also the patients who volunteer for our studies. These volunteers made deep commitments to clinical study participation, so when COVID-19 first emerged, we made every effort to ensure that those enrolled in clinical trials in affected areas were able to continue their treatment and receive appropriate care and monitoring.
Our clinical trials team quickly created plans that could be adapted as we learned more from the rapidly evolving environment. Clinical trials teams throughout the world implemented business continuity plans developed for their local needs, regulations, guidance and circumstances.
“Even in the best of circumstances, it is a tremendous effort managing the operational complexity of our clinical trials,” said Andy Lee, senior vice president and head of Global Clinical Trial Operations (GCTO). “Ensuring clinical trial continuity during a pandemic requires extraordinary effort, especially in very ill patients with life-threatening illnesses and unmet medical needs. I am extremely humbled by and proud of the amazing lengths that individuals and teams have gone to in order to ensure that no patient is left behind.”
Here are a few snapshots of the many incredible stories from our team that continue to inspire us:
In Italy, a 17-year-old patient enrolled in one of our oncology trials returned home to Romania and was unable to reach the site in Italy due to COVID-19 travel restrictions. The local teams worked quickly with regulators and ethics committees to find an experienced local study site, developed a special courier route for the drug transfer, and trained the local Romanian investigators and staff on the treatment protocol. Ultimately, the patient was able to access the treatment on time at a clinical site in Romania, and continued participation in the trial.
In Colombia, our team identified creative travel options, including a canoe ride and a 10-hour road trip to help a patient reach a site for treatment.
In Russia, after two of our sites in Moscow were designated as COVID-19 focused treatment centers, our team re-assigned more than 35 patients to a specialty oncology site so they could continue their treatment and monitoring. None of the impacted patients missed their medication dosing.
“This is the result of a close and sincere collaboration between many partners, including regulatory authorities, clinical sites, global teams and more, to help patients when they are truly at a loss as to what they can and should do to ensure they can continue treatment,” said Paola Paleari, associate director, clinical research, and the clinical research manager in Italy who helped activate the local team. “This is yet another reason why I am proud to work for an organization that goes to such great lengths to help each and every patient.”