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Personalized (N-of-1) Trials for Patient-Centered Treatments of Multimorbidity.
(MIT Press, 2022-09-08)
Treatment of patients who suffer from concurrent health conditions is not well served by (1) evidence-based clinical guidelines that mainly specify treatment of single conditions and (2) conventional randomized controlled ...
Statistical methods and data visualisation of patient-reported outcomes in early phase dose-finding oncology trials: a methodological review.
(ELSEVIER, 2023-10-01)
BACKGROUND: Traditionally, within dose-finding clinical trials, treatment toxicity and tolerability are assessed by clinicians. Research has shown that clinician reporting may have inadequate inter-rater reliability, poor ...
Medicines and Healthcare products Regulatory Agency’s “Consultation on proposals for legislative changes for clinical trials”: a response from the Trials Methodology Research Partnership Adaptive Designs Working Group, with a focus on data sharing
(Springer Science and Business Media LLC, 2023-10-05)
<jats:title>Abstract</jats:title><jats:p>In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals “to improve and strengthen the UK clinical trials legislation to help us make the UK the ...
SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol.
(BMJ PUBLISHING GROUP, 2023-03-29)
INTRODUCTION: Early phase dose-finding (EPDF) studies are critical for the development of new treatments, directly influencing whether compounds or interventions can be investigated in further trials to confirm their safety ...
Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial.
(CELL PRESS, 2023-12-19)
Macrophage Clever-1 contributes to impaired antigen presentation and suppression of anti-tumor immunity. This first-in-human trial investigates the safety and tolerability of Clever-1 blockade with bexmarilimab in patients ...
Results and lessons learnt from the WISTERIA phase I trial combining AZD1775 with cisplatin pre- or post-operatively in head and neck cancer
(Springer Science and Business Media LLC, 2024-01-29)
<jats:title>Abstract</jats:title><jats:sec>
<jats:title>Background</jats:title>
<jats:p>Pre-clinical studies suggest AZD1775, a WEE1 kinase inhibitor, potentiates the activity of various ...
Discarded livers tested by normothermic machine perfusion in the VITTAL trial: Secondary end points and 5-year outcomes.
(LIPPINCOTT WILLIAMS & WILKINS, 2024-01-01)
Normothermic machine perfusion (NMP) enables pretransplant assessment of high-risk donor livers. The VITTAL trial demonstrated that 71% of the currently discarded organs could be transplanted with 100% 90-day patient and ...
Handling Incomplete or Late-Onset Toxicities in Early-Phase Dose-Finding Clinical Trials: Current Practice and Future Prospects.
(American Society of Clinical Oncology (ASCO), 2024-01-01)
PURPOSE: The way late-onset toxicities are managed can affect trial outcomes and participant safety. Specifically, participants often might not have completed their entire follow-up period to observe any toxicities before ...
Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review.
(ELSEVIER, 2023-06-01)
BACKGROUND: The paradigm of early phase dose-finding trials has evolved in recent years. Innovative dose-finding designs and protocols which combine phases I and II are becoming more popular in health research. However, ...
Exploring the barriers to, and importance of, participant diversity in early-phase clinical trials: an interview-based qualitative study of professionals and patient and public representatives.
(BMJ, 2024-03-19)
OBJECTIVES: To explore the importance of, and barriers to achieving, diversity in early-phase clinical trials. DESIGN: Qualitative interviews analysed using thematic analysis. SETTING AND PARTICIPANTS: Five professionals ...