Browsing Clinical Studies by author "Yap, Christina"
Now showing items 21-40 of 45
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Personalized (N-of-1) Trials for Patient-Centered Treatments of Multimorbidity.
Suls, JM; Alfano, C; Yap, C (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 ... -
Phase 1, dose-escalation study of guadecitabine (SGI-110) in combination with pembrolizumab in patients with solid tumors.
Papadatos-Pastos, D; Yuan, W; Pal, A; Crespo, M; Ferreira, A; et al. (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 ... -
Phase I trial of WEE1 inhibition with chemotherapy and radiotherapy as adjuvant treatment, and a window of opportunity trial with cisplatin in patients with head and neck cancer: the WISTERIA trial protocol.
Kong, A; Good, J; Kirkham, A; Savage, J; Mant, R; et al. (BMJ PUBLISHING GROUP, 2020-03-16)INTRODUCTION: Patients with head and neck squamous cell carcinoma with locally advanced disease often require multimodality treatment with surgery, radiotherapy and/or chemotherapy. Adjuvant radiotherapy with concurrent ... -
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.
Copland, M; Slade, D; McIlroy, G; Horne, G; Byrne, JL; et al. (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). ... -
Practical guidance for planning resources required to support publicly-funded adaptive clinical trials.
Wason, JMS; Dimairo, M; Biggs, K; Bowden, S; Brown, J; et al. (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 ... -
Practical guidance for running late-phase platform protocols for clinical trials: lessons from experienced UK clinical trials units.
Love, SB; Cafferty, F; Snowdon, C; Carty, K; Savage, J; et al. (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 ... -
Reporting quality of CONSORT flow diagrams in published early phase dose-finding clinical trial reports: Improvement is needed.
Alger, E; Zhang, Y; Yap, C (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 ... -
Results and lessons learnt from the WISTERIA phase I trial combining AZD1775 with cisplatin pre- or post-operatively in head and neck cancer
Kong, A; Kirkham, AJ; Savage, JS; Mant, R; Lax, S; et al. (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 ... -
Ruxolitinib Versus Best Available Therapy for Polycythemia Vera Intolerant or Resistant to Hydroxycarbamide in a Randomized Trial.
Harrison, CN; Nangalia, J; Boucher, R; Jackson, A; Yap, C; et al. (LIPPINCOTT WILLIAMS & WILKINS, 2023-07-01)PURPOSE: Polycythemia vera (PV) is characterized by JAK/STAT activation, thrombotic/hemorrhagic events, systemic symptoms, and disease transformation. In high-risk PV, ruxolitinib controls blood counts and improves symptoms. ... -
Ruxolitinib versus best available therapy for PV intolerant or resistant to Hydroxycarbamide a randomised trial
Harrison, C; Nangalia, J; Boucher, R; Jackson, A; Yap, C; et al. (WILEY, 2023-04-01) -
SPIRIT and CONSORT extensions for early phase dose-finding clinical trials: the DEFINE (DosE-FIndiNg Extensions) study protocol.
Espinasse, A; Solovyeva, O; Dimairo, M; Weir, C; Jaki, T; et al. (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 ... -
Standardisation of labial salivary gland histopathology in clinical trials in primary Sjögren's syndrome.
Fisher, BA; Jonsson, R; Daniels, T; Bombardieri, M; Brown, RM; et al. (BMJ PUBLISHING GROUP, 2017-07-01)Labial salivary gland (LSG) biopsy is used in the classification of primary Sjögren's syndrome (PSS) and in patient stratification in clinical trials. It may also function as a biomarker. The acquisition of tissue and ... -
Statistical methods and data visualisation of patient-reported outcomes in early phase dose-finding oncology trials: a methodological review.
Alger, E; Minchom, A; Lee Aiyegbusi, O; Schipper, M; Yap, C (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 ... -
Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT).
Pal, A; Stapleton, S; Yap, C; Lai-Kwon, J; Daly, R; et al. (BMJ PUBLISHING GROUP, 2021-09-06)INTRODUCTION: Early phase cancer clinical trials have become increasingly complicated in terms of patient selection and trial procedures-this is reflected in the increasing length of participant information sheets (PIS). ... -
Subgroup analyses in randomized controlled trials frequently categorized continuous subgroup information.
Williamson, SF; Grayling, MJ; Mander, AP; Noor, NM; Savage, JS; et al. (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 ... -
Targeting synovial fibroblast proliferation in rheumatoid arthritis (TRAFIC): an open-label, dose-finding, phase 1b trial.
Pratt, AG; Siebert, S; Cole, M; Stocken, DD; Yap, C; et al. (ELSEVIER, 2021-05-01)BACKGROUND: Current rheumatoid arthritis therapies target immune inflammation and are subject to ceiling effects. Seliciclib is an orally available cyclin-dependent kinase inhibitor that suppresses proliferation of synovial ... -
The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.
Dimairo, M; Pallmann, P; Wason, J; Todd, S; Jaki, T; et al. (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 ... -
The need for reporting guidelines for early phase dose-finding trials: Dose-Finding CONSORT Extension.
Yap, C; Bedding, A; de Bono, J; Dimairo, M; Espinasse, A; et al. (NATURE PORTFOLIO, 2022-01-06) -
The poor outcome in high molecular risk, hydroxycarbamide-resistant/intolerant ET is not ameliorated by ruxolitinib.
O'Sullivan, JM; Hamblin, A; Yap, C; Fox, S; Boucher, R; et al. (AMER SOC HEMATOLOGY, 2019-12-05)Essential Thrombocythemia (ET) patients at high-risk of thrombosis require cytoreductive treatment, typically with hydroxycarbamide. Many patients are resistant or intolerant to hydroxycarbamide (HC-RES/INT) and are at ... -
TRAFIC: statistical design and analysis plan for a pragmatic early phase 1/2 Bayesian adaptive dose escalation trial in rheumatoid arthritis.
Cole, M; Yap, C; Buckley, C; Ng, WF; McInnes, I; et al. (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. ...