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Now showing items 1-10 of 11
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 ...
Ponatinib with fludarabine, cytarabine, idarubicin, and granulocyte colony-stimulating factor chemotherapy for patients with blast-phase chronic myeloid leukaemia (MATCHPOINT): a single-arm, multicentre, phase 1/2 trial.
(ELSEVIER SCI LTD, 2022-02-01)
BACKGROUND: Outcomes for patients with blast-phase chronic myeloid leukaemia are poor. Long-term survival depends on reaching a second chronic phase, followed by allogeneic haematopoietic stem-cell transplantation (HSCT). ...
Implementation of platform trials in the COVID-19 pandemic: A rapid review.
(ELSEVIER SCIENCE INC, 2022-01-01)
MOTIVATION: Platform designs - master protocols that allow for new treatment arms to be added over time - have gained considerable attention in recent years. Between 2001 and 2019, 16 platform trials were initiated globally. ...
The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension.
(NATURE PORTFOLIO, 2022-01-06)
Phase 1, dose-escalation study of guadecitabine (SGI-110) in combination with pembrolizumab in patients with solid tumors.
(BMJ PUBLISHING GROUP, 2022-06-01)
BACKGROUND: Data suggest that immunomodulation induced by DNA hypomethylating agents can sensitize tumors to immune checkpoint inhibitors. We conducted a phase 1 dose-escalation trial (NCT02998567) of guadecitabine and ...
Early phase clinical trials extension to guidelines for the content of statistical analysis plans.
(BMJ PUBLISHING GROUP, 2022-02-07)
This paper reports guidelines for the content of statistical analysis plans for early phase clinical trials, ensuring specification of the minimum reporting analysis requirements, by detailing extensions (11 new items) and ...
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 ...
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 ...
Using Patient-Reported Outcomes in Dose-Finding Oncology Trials: Surveys of Key Stakeholders and the National Cancer Research Institute Consumer Forum.
(OXFORD UNIV PRESS, 2022-09-02)
BACKGROUND: Patient-reported adverse events may be a useful adjunct for assessing a drug's tolerability in dose-finding oncology trials (DFOT). We conducted surveys of international stakeholders and the National Cancer ...
Subgroup analyses in randomized controlled trials frequently categorized continuous subgroup information.
(ELSEVIER SCIENCE INC, 2022-07-02)
BACKGROUND AND OBJECTIVES: To investigate how subgroup analyses of published Randomized Controlled Trials (RCTs) are performed when subgroups are created from continuous variables. METHODS: We carried out a review of RCTs ...