117 research outputs found
Myocardial first pass inmaging with MS-325, a new intravascular magnetic resonance contrast agent
THE EFFECTS OF DECREASED NORADRENERGIC TRANSMISSION ON RAPID EYE MOVEMENT SLEEP IN RATS (REMS).
THE EFFECTS OF DECREASED NORADRENERGIC TRANSMISSION ON RAPID EYE MOVEMENT SLEEP IN RATS (REMS)
Technetium-99m complexes of ester derivatized diamine-dithiol ligands for imaging brain perfusion
Perfusion imaging of pancreas allografts using technetium-99m hexamethyl propylene amine oxime
Subjective endpoints in clinical trials: the case for blinded independent central review
Richard Walovitch,1 Bin Yao,2 Patrick Chokron,1 Helen Le,1 Glenn Bubley3 1WorldCare Clinical, LLC, Boston, MA, USA; 2Amgen, Inc, Thousand Oaks, CA, USA; 3Director of Genitourinary Medical Oncology, Beth Israel Deaconess Medical Center, Boston, MA, USA Abstract: Primary efficacy and safety endpoints in clinical trials are often subjective assessments made by site personnel. For international confirmatory trials conducted over broad geographic regions and different clinical practice settings, variability in these subjective assessments can be substantial. Centralized endpoint assessment committees (EACs) offer a mechanism through which to reduce assessment bias and potentially increase assessment precision and accuracy, particularly in open-label trials. An overview of regulatory agencies' rationales for an EAC is reviewed. In addition, the two main types of EACs, the blinded independent central review, and the consensus panel are compared. Selection of endpoints for EAC evaluation and design of EAC process to maximize EAC value proposition are also discussed. Keywords: endpoint assessment committee, FDA, central review, BICR, adjudication, consensus pane
US FDA draft Guidance Standard for Clinical Trial Imaging Endpoints: more than just imaging?
Joint reconstruction of Ictal/inter-ictal SPECT data for improved epileptic foci localization
Entwicklung und klinische Anwendung von Neurolite (Kit fĂĽr die Herstellung von 99mTc-Bicisat)
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