scholarly journals Evaluating the effectiveness of the clinical research radiographer undertaking the on-treatment review of clinical trial patients receiving radiotherapy for prostate cancer

2018 ◽  
Vol 18 (02) ◽  
pp. 123-126
Author(s):  
Stacey Murray ◽  
Terri M Gilleece ◽  
Paul H Shepherd
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Prostate Cancer Patient ◽  
Advanced Practice ◽  
Roles And Responsibilities ◽  
Treatment Review

AbstractBackgroundRadiotherapy clinical trials are at the forefront of modern-day prostate cancer patient management. Patients are reviewed during treatment by clinical oncologists or competent on-treatment review radiographers to minimise treatment toxicities. Clinical Research Radiographers (CRRs) routinely monitor and gather research data from patients participating in clinical trials.PurposeThe aim of this article is to evaluate the effectiveness of the CRR undertaking the on-treatment review of clinical trial patients.MethodAn experienced CRR within the Northern Ireland Cancer Trials Network was supervised by a clinical oncologist to undertake the role of the on-treatment review of patients receiving radiotherapy for prostate cancer. The CRR explored published literature and compiled this written evaluation as part of their advanced practice learning.ResultsThe supervising clinical oncologist verified, following the planned period of supervised practice and academic study, that the CRR was competent to fulfil the role. Evidence of the beneficial synergistic impact of co-joining the roles was experienced at first hand during the undertaking of supervised practice.ConclusionCo-joining the roles and responsibilities of the CRR and the on-treatment review radiographer enhanced the quality of care offered to the patients participating in clinical trials.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator's service fee in drug clinical trial research fund and its impact on trial quality

2020 ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective: The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed.Methods: This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc.Result: The most significant appearance and increase in volume and proportion were the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500,accounted for 33.74%.Discussion: It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator.

scholarly journals The role of a data manager at a clinical trial center: the experience of the Alessandria hospital, Italy

2020 ◽  
Vol 8 (1) ◽  
Author(s):  
Fabio Giacchero ◽  
Carolina Pelazza ◽  
Serena Panpa ◽  
Marinella Bertolotti ◽  
Tatiana Bolgeo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Reference Period ◽  
Job Description ◽  
Data Manager

Objectives: To define the Data Manager (DM) job description within the Clinical Trial Center (CTC) of the Alessandria Hospital (AO AL). To identify the number of authorized clinical studies after the implementation of three DMs in the CTC of the AO AL. Methods: The activities of the DM within the CTC of the AO AL take place in the activation, management and conclusion of clinical trials. The activities were monitored through specific indicators from June 01st, 2019 to May 31st, 2020. Results: During the reference period, an increased authorized studies were observed. Conclusion: The implementation of DMs in the CTC of AO AL has been demonstrated the importance of the figure itself, which, although it has not professionally recognized yet, is found to be fundamental in clinical research.

REACT: A feasibility study to test the integration of a cancer registry early case ascertainment process via electronic pathology reporting with an online clinical trial matching tool.

2020 ◽  
Vol 38 (6_suppl) ◽  
pp. 207-207
Author(s):  
Hala Borno ◽  
Christine Duffy ◽  
Sylvia Zhang ◽  
Zinnia Loya ◽  
Todd Golden ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Feasibility Study ◽  
Cancer Registry ◽  
Cancer Clinical Trials ◽  
Case Ascertainment ◽  
Early Case ◽  
Diverse Patient Populations

207 Background: Representation of diverse patient populations in prostate cancer clinical trials is essential to ensure results are applicable to all men. However, underrepresentation among underserved populations remains a critical problem. Population-based cancer registries provide a potential platform to overcome problems with inclusion of diverse patient populations in clinical research when used as a source for recruitment. Methods: Leveraging statewide implementation of early-case ascertainment (ECA) via electronic pathology for cancer case identification, we performed a feasibility study within the Greater Bay Area Cancer Registry to (1) test a process using ECA to identify new cases of advanced prostate cancer for potential enrollment into clinical trials and (2) test the utility of an online clinical trial matching tool to improve matching of underrepresented patients into clinical trials. All study materials were translated into Spanish, and recruiters were Spanish-speaking. Results: A total of 419 cases were identified from 19 reporting facilities through ECA and sent invitation letters; 18 cases were excluded due to physician contraindication, and 68 (16%) declined participation. All enrolled participants (N=54) completed baseline surveys. To date, 40 participants completed follow-up surveys after using the online matching tool. Most participants were White (80%), of higher income (>$150,000; 41%), and college-educated (70%). Thirty-seven percent indicated awareness of cancer clinical trials, 69% stated interest in participating in clinical research, and 72% held a positive attitude towards cancer clinical trials. However, 46% indicated they would not participate in a randomized study. To assess utility of the matching tool, 65% indicated it increased their interest in participating in a clinical trial. Conclusions: ECA needs to ensure sociodemographic data are available to make it useful as a tool for clinical trials. Preliminary results indicate ECA used in combination with an online clinical trial matching tool may serve as an important recruitment vehicle for prostate cancer clinical trials.

scholarly journals The appearance and increase in the quantity and proportion of the clinical research coordinator’s service fee in drug clinical trial research fund and its impact on trial quality

2021 ◽  
Vol 19 (1) ◽  
Author(s):  
Liran Chen ◽  
Zhimin Chen ◽  
Huafang Chen
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Structural Changes ◽  
Continuous Increase ◽  
Clinical Trial Research ◽  
Clinical Research Coordinator ◽  
Research Coordinator ◽  
Drug Clinical Trial

Abstract Objective The changes of absolute value and relative value of clinical research coordinator service fee and its influence on the quality of drug clinical trial were analyzed. Methods This study compared the amount and structural changes of drug clinical trial costs in before 3 years and after 3 years of self-examination and inspection initiated by the China Food and Drug Administration, identified the increase number and composition of each individual cost of a clinical trial research funds which including clinical research coordinator service fee, investigator labor fee, subjects examination fee, subjects traffic subsidy, documents management fee, drug management fee, etc. Result The most significant appearance of increase in volume and proportion was the clinical research coordinator service fee. From the initial few to the global multicenter tumor drug clinical trials RMB31,624 or 34.92% of the proportion and domestic multicenter tumor drug clinical trials RMB16,500, accounted for 33.74%. Discussion It has become common for more money to be spent on clinical trials to be accompanied by improved quality, but the occurrence and continuous increase of clinical research coordinator service fee were divided into two aspects, On the one hand, the quality of clinical trials was promoted by the large amount of low-skill trivial work undertaken by clinical research coordinator; on the other hand, the quality of clinical trials was undermined by the fact that clinical research coordinator did too much treatment evaluation work that should have been done by the investigator. Conclusion The clinical research coordinators’ access standards, pre-employment training and examination, job and performance evaluation, in addition to the SMO specification management and avoiding malicious competition between the industry, are important factors in the quality assurance of drug clinical trials.

scholarly journals Managing clinical trials during COVID-19: experience from a clinical research facility

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Frances Shiely ◽  
Jean Foley ◽  
Amy Stone ◽  
Emma Cobbe ◽  
Shaunagh Browne ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Best Practices ◽  
Clinical Research ◽  
Research Facility ◽  
Clinical Research Facility ◽  
Key Issues ◽  
Practical Guidance ◽  
Trial Manager

AbstractThere is a dearth of literature on best practices for managing clinical trials, and little is understood on the role of the clinical trial manager. The COVID-19 pandemic has brought this into focus, and the continuance of clinical trials worldwide has been catapulted into a state of uncertainty as countries enter lockdown to manage the spread of the virus. Participant retention is an ongoing issue in clinical trials, and the concern is that in the current pandemic environment, attrition will be an issue which could potentially jeopardise trial completion. The current situation has necessitated timely problem solving by the trial manager to ensure trials remain open, and most importantly, that participant safety, paramount in clinical trials, is monitored. The purpose of our study is to highlight key issues arising in the management of clinical trials during a pandemic from first-hand experience in a clinical research facility managing both academic and commercial clinical trials. We offer some practical guidance on solution implementation.

The multi-disciplinary meeting as a tool to identify patients for clinical trials and translational research.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e14001-e14001
Author(s):  
H Winter ◽  
David Rea
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Translational Research ◽  
Solid Tumour ◽  
Outcome Data ◽  
Team Meetings ◽  
Proactive Approach ◽  
The Uk

e14001 Background: Cancer multi-disciplinary team meetings (MDTs) were established with one of the core aims to increase participation in clinical research. However, a recent Cancer Research UK study observing 624 patient MDT discussions revealed only 8 (1.3%) patients included a discussion on clinical trials. Current work in the UK looking at MDT effectiveness has explored the quality of discussions and team dynamics. However, recruitment to clinical trials has not been promoted as an indicator of an effective MDT. This study explored the role of MDTs in identifying patients for research across all solid tumour MDTs in a tertiary cancer centre. Methods: This study explored the outcome data from solid tumour MDTS; reports on the observation of solid tumour MDTs and completion of a trials and translational proforma about patient discussions on research; exploration of MDT members views on the role of MDTS in identifying opportunities for patients to participate in clinical trials and translational research. Results: MDT outcomes from all solid tumour MDTs were reviewed. Out of 7000 local MDT outcomes from Avon Cancer Registry April 2019- Set 2019. Only 409 discussions included an outcome registered with “Clinical Trial y/n” (5%). In the majority there was no mention of any consideration of clinical trial or an explicit trial documented. Conclusions: We report on the exploration of the MDT as integral to identifying patients for clinical trials and translational research. This requires input and buy in from MDT members and the identification of research champions attending MDTs. The integration of genomics data into MDTs will require a proactive approach to access clinical trials for patients with identified potential actionable targets.

Clinical Research in Metastatic Prostate Cancer: A Focus on Impact and Value

2015 ◽  
pp. 17-21 ◽  
Author(s):  
Maha Hussain ◽  
Robert S. DiPaola
Keyword(s):  
Quality Of Life ◽  
Prostate Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Metastatic Prostate Cancer ◽  
Complex Disease ◽  
Clinical Impact ◽  
Critical Pathways ◽  
Key Points

KEY POINTS Several therapies targeting the androgen receptor and other pathways have improved survival and quality of life for patients with metastatic prostate cancer. Many costly therapeutic clinical trial efforts have failed to improve outcomes. Prostate cancer is a complex disease. Its biologic heterogeneity warrants that future clinical trials be carefully designed to achieve higher levels of clinical impact by attention to targeting more critical pathways; integrating improved diagnostics; well-designed and powered clinical trials using multi-targeted strategies; and optimized timing of therapy.

PD-L1 Inhibitors for the Treatment of Prostate Cancer

2020 ◽  
Vol 21 (15) ◽  
pp. 1558-1565
Author(s):  
Matteo Santoni ◽  
Francesco Massari ◽  
Liang Cheng ◽  
Alessia Cimadamore ◽  
Marina Scarpelli ◽  
...  
Keyword(s):  
Prostate Cancer ◽  
Clinical Trials ◽  
T Lymphocytes ◽  
Chronic Inflammation ◽  
Immune Cells ◽  
Response To Therapy ◽  
Complex Series

The carcinogenesis of prostate cancer (PCa) results from a complex series of events. Chronic inflammation and infections are crucial in this context. Infiltrating M2 type macrophages, as well as neutrophils and T lymphocytes, contribute to PCa development, progression and response to therapy. The preliminary findings on the efficacy of immunotherapy in patients with PCa were not encouraging. However, a series of studies investigating anti-PD-L1 agents such as Atezolizumab, Avelumab and Durvalumab used alone or in combination with other immunotherapies, chemotherapy or locoregional approaches are in course in this tumor. In this review, we illustrate the role of immune cells and PD-L1 expression during PCa carcinogenesis and progression, with a focus on ongoing clinical trials on anti-PD-L1 agents in this context.

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