Clinical Trial Update In Light Of COVID-19
In these unprecedented times, hundreds of clinical trials have been suspended, but many studies are still able to continue as planned and offer support to patients. The Food and Drug Administration (FDA) has published new guidelines for clinical trials, creating more flexibility for researchers during the COVID-19 pandemic. These new regulations allow studies to adapt by permitting nuanced approaches, including sending pharmaceuticals by mail and conducting virtual consultations with patients
In light of the current global health crisis, we want to make sure to keep you in loop on all PHASE ONE ongoing and active trials. Listed below are updates from PHASE ONE grantees and the current status of their various research.
DR. JASON SICKLICK, GASTROINTESTINAL STROMAL TUMORS, UCSD SCHOOL OF MEDICINE
Good news! This trial is currently still active and has already enrolled their first 5 patients since opening earlier this year. However, COVID-19 has slowed down the progress in establishing this trial at other sites around the country. Regardless, Dr. Sicklick is very confident that every location will be up and running soon and proceed as planned.
DR. NOAH FEDERMAN, RHADOMYOSARCOMA, UCLA
We are happy to share that Dr. Federman's study has received approval to move forward despite COVID-19 and is able to continue to enroll new subjects during this time. In fact, Dr. Federman will be admitting a few new patients as early as the next two weeks. This is a huge potential benefit to his cancer patients, most of whom are children and young adults. We appreciate Dr. Federman's determination to help his patients in hopes of offering them a full and joyous life ahead
DR. SANTOSH KESARI, GLIOBLASTOMA, SAINT JOHN'S HEALTH CENTER
Dr. Kesari and his team are still enrolling new patients, although enrollment has slowed due to the epidemic, and making a lot of virtual visits. They have patients coming from Ohio and northern California even after assessing the risk benefit ratio of the pandemic, since cancer doesn't stop. We are so glad to hear that all of Dr. Kesari's patients are still in such good care.
DR. LINDA LIAU & DR. TIMOTHY CLOUGHESY, GLIOBLASTOMA, UCLA
Due to the COVID-19 pandemic, Dr. Liau and Dr. Cloughesy's clinical trial is currently on pause. Once the trial is reactivated the pace of enrollment will be dictated by the status of COVID-19 over the next year, but they anticipate that they will be able to enroll one patient every 2-3 weeks. Given that the trial already had rapid enrollment prior to the crisis, both doctors are optimistic and hopeful that their study will be allowed to resume again as early as next month. We are endlessly impressed by both Dr. Liau and Dr. Cloughesy and we expect great results from their trial moving forward.
DR. MAIE ST. JOHN, HEAD & NECK CANCER, UCLA
Even in light of the COVID-19 pandemic, which has limited staff resources and prohibited certain access, Dr. Maie St. John and her team continue to achieve their goal of making great progress on the DOCi surgical instrument. Their industry may have slowed down, but Dr. Maie St. John has reported that they are doing everything they can to continue their work as planned. The DOCi has already radically changed the possibilities for surgeons operating on cancer patients and this is exactly the type of innovation and forward-thinking PHASE ONE is proud to support.
DR. KARIM CHAMIE, UROTHELIAL CARCINOMA, UCLA
Due to current events, Dr. Chamie's clinical trial is currently on pause, including all lab work. Once restrictions are lifted, Dr. Chamie is very excited to pick up and resume his research. He is very passionate about his trial and looks forward to providing a thorough update by December.
He added, "The work PHASE ONE supports is truly life-saving."