Browsing ICR Divisions by author "Yap, Christina"
Now showing items 1-20 of 49
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A risk-based approach to experimental early phase clinical trials during the COVID-19 pandemic.
Tiu, C; Shinde, R; Yap, C; Rao Baikady, B; Banerji, U; et al. (ELSEVIER SCIENCE INC, 2020-07-01) -
Adaptive trial designs: what are multiarm, multistage trials?
Millen, GC; Yap, C (BMJ PUBLISHING GROUP, 2020-12-01) -
Adaptive trial designs: what is the continual reassessment method?
Millen, GC; Yap, C (BMJ PUBLISHING GROUP, 2021-06-01) -
Adult brain tumour research in 2024: Status, challenges and recommendations.
Purshouse, K; Bulbeck, HJ; Rooney, AG; Noble, KE; Carruthers, RD; et al. (WILEY, 2024-04-01)In 2015, a groundswell of brain tumour patient, carer and charity activism compelled the UK Minister for Life Sciences to form a brain tumour research task and finish group. This resulted, in 2018, with the UK government ... -
Assessing the reporting quality of early phase dose-finding trial protocols: a methodological review.
Villacampa, G; Patel, D; Zheng, H; McAleese, J; Rekowski, J; et al. (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, ... -
Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: The phase I/II first-in-human MATINS trial.
Rannikko, JH; Verlingue, L; de Miguel, M; Pasanen, A; Robbrecht, D; et al. (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 ... -
Combination Lenalidomide and Azacitidine: A Novel Salvage Therapy in Patients Who Relapse After Allogeneic Stem-Cell Transplantation for Acute Myeloid Leukemia.
Craddock, C; Slade, D; De Santo, C; Wheat, R; Ferguson, P; et al. (AMER SOC CLINICAL ONCOLOGY, 2019-03-01)PURPOSE: Salvage options for patients who relapse after allogeneic stem-cell transplantation (allo-SCT) for acute myeloid leukemia (AML) and myelodysplasia (MDS) remain limited, and novel treatment strategies are required. ... -
Costs and staffing resource requirements for adaptive clinical trials: quantitative and qualitative results from the Costing Adaptive Trials project.
Wilson, N; Biggs, K; Bowden, S; Brown, J; Dimairo, M; et al. (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 ... -
Designing and evaluating dose-escalation studies made easy: The MoDEsT web app.
Pallmann, P; Wan, F; Mander, AP; Wheeler, GM; Yap, C; et al. (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 ... -
Development of consensus-driven SPIRIT and CONSORT extensions for early phase dose-finding trials: the DEFINE study.
Solovyeva, O; Dimairo, M; Weir, CJ; Hee, SW; Espinasse, A; et al. (BMC, 2023-07-05)BACKGROUND: Early phase dose-finding (EPDF) trials are crucial for the development of a new intervention and influence whether it should be investigated in further trials. Guidance exists for clinical trial protocols and ... -
Discarded livers tested by normothermic machine perfusion in the VITTAL trial: Secondary end points and 5-year outcomes.
Mergental, H; Laing, RW; Kirkham, AJ; Clarke, G; Boteon, YL; et al. (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 ... -
Early phase clinical trials extension to guidelines for the content of statistical analysis plans.
Homer, V; Yap, C; Bond, S; Holmes, J; Stocken, D; et al. (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 ... -
Enhancing quality and impact of early phase dose-finding clinical trial protocols: SPIRIT Dose-finding Extension (SPIRIT-DEFINE) guidance.
Yap, C; Rekowski, J; Ursino, M; Solovyeva, O; Patel, D; et al. (BMJ PUBLISHING GROUP, 2023-10-20) -
Enhancing reporting quality and impact of early phase dose-finding clinical trials: CONSORT Dose-finding Extension (CONSORT-DEFINE) guidance.
Yap, C; Solovyeva, O; de Bono, J; Rekowski, J; Patel, D; et al. (BMJ PUBLISHING GROUP, 2023-10-20)The CONSORT (CONsolidated Standards Of Reporting Trials) 2010 statement is the standard guideline for reporting completed randomised trials. The CONSORT Dose-finding Extension (DEFINE) extends the guidance (with 21 new ... -
Ethical Considerations for the Inclusion of Patient-Reported Outcomes in Clinical Research: The PRO Ethics Guidelines.
Cruz Rivera, S; Aiyegbusi, OL; Ives, J; Draper, H; Mercieca-Bebber, R; et al. (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 ... -
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.
Chatters, R; Dimairo, M; Cooper, C; Ditta, S; Woodward, J; et al. (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 ... -
From patent to patient: analysing access to innovative cancer drugs.
Sharpe, E; Hoey, R; Yap, C; Workman, P (ELSEVIER SCI LTD, 2020-09-01)Analysis of cancer drugs licensed through the European Medicines Agency (EMA) in 2000-2016 shows that the number of authorisations increased over that timeframe. The median number of licensed drugs each year rose from six ... -
Handling Incomplete or Late-Onset Toxicities in Early-Phase Dose-Finding Clinical Trials: Current Practice and Future Prospects.
Yin, Z; Mander, AP; de Bono, JS; Zheng, H; Yap, C (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 ... -
How to design a dose-finding study using the continual reassessment method.
Wheeler, GM; Mander, AP; Bedding, A; Brock, K; Cornelius, V; et al. (BMC, 2019-01-18)INTRODUCTION: The continual reassessment method (CRM) is a model-based design for phase I trials, which aims to find the maximum tolerated dose (MTD) of a new therapy. The CRM has been shown to be more accurate in targeting ... -
Immune Biomarkers in Metastatic Castration-resistant Prostate Cancer.
Fenor de la Maza, MD; Chandran, K; Rekowski, J; Shui, IM; Gurel, B; et al. (ELSEVIER, 2022-04-28)BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) is a heterogeneous disease in which molecular stratification is needed to improve clinical outcomes. The identification of predictive biomarkers can have ...