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Transplantation of discarded livers following viability testing with normothermic machine perfusion.
(NATURE PORTFOLIO, 2020-06-16)
There is a limited access to liver transplantation, however, many organs are discarded based on subjective assessment only. Here we report the VITTAL clinical trial (ClinicalTrials.gov number NCT02740608) outcomes, using ...
Designing and evaluating dose-escalation studies made easy: The MoDEsT web app.
(SAGE PUBLICATIONS LTD, 2020-04-01)
BACKGROUND/AIMS: Dose-escalation studies are essential in the early stages of developing novel treatments, when the aim is to find a safe dose for administration in humans. Despite their great importance, many dose-escalation ...
A risk-based approach to experimental early phase clinical trials during the COVID-19 pandemic.
(ELSEVIER SCIENCE INC, 2020-07-01)
Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units.
(BMC, 2022-09-06)
BACKGROUND: Late-phase platform protocols (including basket, umbrella, multi-arm multi-stage (MAMS), and master protocols) are generally agreed to be more efficient than traditional two-arm clinical trial designs but are ...
Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.
(BMC, 2021-10-26)
BACKGROUND: Adaptive designs offer great promise in improving the efficiency and patient-benefit of clinical trials. An important barrier to further increased use is a lack of understanding about which additional resources ...
Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.
(BMC, 2022-08-10)
Adaptive designs are a class of methods for improving efficiency and patient benefit of clinical trials. Although their use has increased in recent years, research suggests they are not used in many situations where they ...
TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis.
(BMC, 2021-07-06)
BACKGROUND: Adaptive model-based dose-finding designs have demonstrated advantages over traditional rule-based designs but have increased statistical complexity but uptake has been slow especially outside of cancer trials. ...
Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.
(AMER MEDICAL ASSOC, 2022-05-17)
IMPORTANCE: Patient-reported outcomes (PROs) can inform health care decisions, regulatory decisions, and health care policy. They also can be used for audit/benchmarking and monitoring symptoms to provide timely care ...
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
(BMC, 2020-06-17)
Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting ...
Reporting quality of CONSORT flow diagrams in published early phase dose-finding clinical trial reports: Improvement is needed.
(ELSEVIER SCIENCE INC, 2023-08-01)
BACKGROUND: This project aims to: (1) assess the completeness of information in flow diagrams of published early phase dose-finding (EPDF) trials based on CONSORT recommendations, and if additional features on dose ...