The role of clinical trial nurses: Transitioning from clinicians to clinical research coordinators

2021 ◽  
Author(s):  
Hye‐Ja Park ◽  
Soyoung Yu
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Clinical Research Coordinators

Shared-Task Worklists Improve Clinical Trial Recruitment Workflow in an Academic Emergency Department

2021 ◽  
Vol 12 (02) ◽  
pp. 293-300
Author(s):  
Kevin S. Naceanceno ◽  
Stacey L. House ◽  
Phillip V. Asaro
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Clinical Trials ◽  
Clinical Research ◽  
Substantial Reduction ◽  
Text Message ◽  
High Volume ◽  
Text Messages ◽  
Shared Task ◽  
Clinical Research Coordinators

Abstract Background Clinical trials performed in our emergency department at Barnes-Jewish Hospital utilize a centralized infrastructure for alerting, screening, and enrollment with rule-based alerts sent to clinical research coordinators. Previously, all alerts were delivered as text messages via dedicated cellular phones. As the number of ongoing clinical trials increased, the volume of alerts grew to an unmanageable level. Therefore, we have changed our primary notification delivery method to study-specific, shared-task worklists integrated with our pre-existing web-based screening documentation system. Objective To evaluate the effects on screening and recruitment workflow of replacing text-message delivery of clinical trial alerts with study-specific shared-task worklists in a high-volume academic emergency department supporting multiple concurrent clinical trials. Methods We analyzed retrospective data on alerting, screening, and enrollment for 10 active clinical trials pre- and postimplementation of shared-task worklists. Results Notifications signaling the presence of potentially eligible subjects for clinical trials were more likely to result in a screen (p < 0.001) with the implementation of shared-task worklists compared with notifications delivered as text messages for 8/10 clinical trials. The change in workflow did not alter the likelihood of a notification resulting in an enrollment (p = 0.473). The Director of Research reported a substantial reduction in the amount of time spent redirecting clinical research coordinator screening activities. Conclusion Shared-task worklists, with the functionalities we have described, offer a viable alternative to delivery of clinical trial alerts via text message directly to clinical research coordinators recruiting for multiple concurrent clinical trials in a high-volume academic emergency department.

scholarly journals Clinical Trial Units in Italy: the perception of the Clinical Research Coordinators

2016 ◽  
Vol 27 ◽  
pp. iv111 ◽  
Author(s):  
C. Cagnazzo ◽  
O. Nanni ◽  
S. Campora ◽  
P. Frati ◽  
R. Camisa ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Research ◽  
Clinical Research Coordinators

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.

Abstract WP333: Clinical Research Coordinators' Barriers and Best Practices to Minority Recruitment in Stroke Clinical Trials

Stroke ◽  
2016 ◽  
Vol 47 (suppl_1) ◽  
Author(s):  
Jazmin Rivera ◽  
Lauren Southwick ◽  
Nina S Parikh ◽  
Sean Haley ◽  
Bernadette Boden-Albala
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Focus Groups ◽  
Team Building ◽  
Patient Centered ◽  
Organizational Barriers ◽  
Internet Resources ◽  
Clinical Research Coordinators ◽  
Recruitment Challenges

Background: Poor recruitment and retention of clinical trial participants continues to be a major contributor to the early termination of many clinical trials. Specifically, low racial-ethnic minority and female participation rates can limit scientific, economic, and ethical value of a clinical trial. Previous literature has explored patient-centered enrollment barriers, while research has yet to investigate recruitment challenges facing clinical research coordinators (CRCs). Aim: To gain insight of the barriers facings CRCs with particular attention to minority and female recruitment efforts. Methods: Two semi-structured focus groups were conducted with a purposive sample of stroke CRCs in 2013 (N=17) and 2014 (N=23). Discussion topics included: 1) integrating NIH Inclusion Policy into trial design and recruitment strategies; 2) experiences recruiting minorities and women in stroke/neurological trials; and 3) strategies to enhance minority and female involvement. Two reviewers independently developed an initial set of base codes (n=6). Reviewers met and reconciled their independent coding using the 2013 transcript before applying the same process to the 2014 transcript. Codes and sub-codes were used to identify thematic areas. Results: Both focus groups included majority female participants with nearly half holding nursing degree. Codes informed three thematic areas: administration, enrollment and “other.” Administrative findings highlight organizational barriers. Enrollment findings identified challenges related to the severity of condition and time limitations. The “other” theme cut across administration and enrollment, often informed by coordinators’ personal experiences. Personal barriers include biases and uncertainty approaching patients from diverse backgrounds. Participants identified coordinator conferences, trainings, Internet resources, direct support from PIs and team building between hospital and research staff as key strategies. Conclusion: Our findings identified multi-dimensional organizational, administrative and resource barriers and the need for more focused CRC support to enhance participant recruitment efforts in stroke clinical research.

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.

scholarly journals Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients

2008 ◽  
Vol 1 (1) ◽  
pp. 26 ◽  
Author(s):  
Hiroaki Yanagawa ◽  
Akiyo Akaishi ◽  
Toshiko Miyamoto ◽  
Shigemi Takai ◽  
Rika Nakanishi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Surgical Patients ◽  
Clinical Research Coordinators

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.

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