Transparency Life Sciences’ Trial to Assess Decentralized Data Collection
Transparency Life Sciences (TLS), a clinical-stage drug development company based on open innovation, announced that the first patient has been enrolled in an innovative ulcerative colitis clinical trial designed to assess the feasibility of replacing most conventional patient site visits with data collected using a combination of decentralized methods, including digital measurements, telemonitoring, remote video visits with clinical trial staff and blood collections by visiting nurses. In addition, the study is the first to allow key clinical endpoint assessments to be made by the subjects’ own gastroenterologists, rather than via designated sub-investigators affiliated with the trial.
The study was commissioned and is funded by a global biopharmaceutical company, and it is being conducted in collaboration with Brigham and Women’s Hospital, a teaching affiliate of Harvard Medical School, and a founding hospital of Partners Healthcare.
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Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Improving Engagement While Maintaining Data Integrity & Validity
March 19th 2024In recognition of Women's Health Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and uMotif's Chief Product Officer, Julia Lakeland, discuss new technologies improving patient engagement and reducing the emotional and logistical burdens of participation, ethical considerations that should be addressed when implementing those technologies, while ensuring patient privacy, and much more.
FDA Grants Ziftomenib with Breakthrough Therapy Designation for NPM1-Mutant Acute Myeloid Leukemia
April 23rd 2024Data from the Phase Ib portion of the KOMET-001 trial showed that the once-daily oral treatment may provide a substantial improvement over available therapies for relapsed/refractory NPM1-mutant acute myeloid leukemia.
