Sentence examples for technical endpoints from inspiring English sources
We here present an evaluation of the most important technical endpoints associated with the use of IIPCS for HAI in patients with primary liver cancers.
Therefore, a substantial part of our presentation deals with the comparison of technical endpoints between the IIPCS and SIPCS for the delivery of 5-fluorouracil-based HAI in patients with colorectal liver metastases.
Primary objective was the evaluation of technical endpoints associated with the use of IIPCS for the application of HAI, comprising complications associated with port implantation and adjacent regional chemotherapy, port duration (defined as time to port occlusion), and reasons for primary and secondary device failure.
In order to further define practicability and safety of our HAI-approach applied via IIPCS we included patients with advanced HCC and BTC in a phase 2-trial in which technical endpoints (complication rates, safety of device and regional therapy) were defined as primary objectives.
Indeed, we strictly focussed our phase II-trial on HAI provided through IIPCS on technical endpoints in a rather descriptive way, and aimed to work out at least an equivalence with the surgical approach within relatively heterogen collectives of patients with colorectal liver metastases.
Patients were provided with an IIPCS and adjacent HAI using oxaliplatin, folinic acid, and 5-FU (regional "OFF -schedule) in the scOFF -scheduley that was inthetionally descoped fof technical endpointstudyorder thatet a more detailed insight into the practicability of the approach.
Of the studies reviewed, ∼40% received a score of "2 Reliable with Restrictions," while ∼60% received a score of "3 Not Reliable," where reliability was interpreted to include scientific integrity, technical credibility, endpoint relevance, and regulatory compliance.
The variability in patient cohorts, clinical endpoints, technical methodology, and quantification, however, require prospective studies in well-characterized patient groups before implementation in daily practice is feasible.
The last section describes the bridging of biomarkers from preclinical laboratory studies into the clinical realm, and the necessary considerations in terms of technical validation of biomarker endpoints, the role of biomarkers as surrogate endpoints and in pharmacokinetic/pharmacodynamic modeling, and how biomarkers may be viewed in a regulatory context.
The primary study endpoints were technical success and safety.
The secondary endpoints included technical success, potential risk factors associated with the leak closure, treatment duration, adverse events and the need for surgery.
