Surrogate designation has the potential to represent the patient's wishes and promote successful family involvement in decision making when options exist a... É Azoulay,CL Sprung - 《Critical Care Medicine》 被引量: 328发表: 2004年 Assessing the surgical skills of trainees in the operating thea...
This study of all FDA approvals granted Breakthrough Therapy designation from 2012 through 2017 suggests that pivotal trials supporting these approvals commonly lacked randomization, double-blinding, and control groups, used surrogate markers as primary end points, and enrolled small numbers of patients...
announced that the U.S. Food and Drug Administration (FDA) granted Regenerative Medicine Advanced Therapy (RMAT) designation to CTX130™, the Company’s wholly owned allogeneic CAR T cell therapy targeting CD70, for the treatment of Mycosis Fungoides...
(2012) found that the reason why the COO was the most important extrinsic cue for the majority of participants when purchasing seafood was that they used it as a proxy or surrogate measure for freshness, superior quality and safety. Imported seafood was perceived to be cheaper but riskier in ...
Multiple encouraging discussions with the FDA in 2024, focused on the validated glycosylated αDG bioassay and our interim analysis plans, continue to support the Company’s plan to pursue Accelerated Approval for BBP-418 based on the use of glycosylated αDG levels as a surrogate endpoint in LG...
Additionally, blood-based biomarker detection can potentially be used to monitor disease progression5 and therapeutic efficacy6, as well as surrogate endpoints7, thus streamlining the translation of research advancements to real-world applications. Blood-based biomarker driven cl...
Using preliminary evidence, rather than a full series of clinical trials, it’s possible that, in many cases, the supporting evidence for the product would be based on surrogate endpoints used to determine clinical efficacy (Accelerated Approval). This would require post...
A procedure for the systematic nomination of a health care surrogate was put in place following a multi-disciplinary approach within an acute care geriatric unit at Ambroise-Par茅 hospital in Boulogne-Billancourt. Its originality lies in the way the whole team, on the initiative of a doctor, ...