scholarly journals The Effect of the Contribution of Clinical Research Coordinators in Clinical Trials at the Nagoya University Hospital.

2002 ◽  
Vol 33 (3) ◽  
pp. 85-91 ◽  
Author(s):  
Hiroyuki KAMEI ◽  
Tsuneko KATO ◽  
Sachiko ANDO ◽  
Yukari NARUSE ◽  
Mayumi ICHINO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
University Hospital ◽  
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.

Tools in a clinical information system supporting clinical trials at a Swiss University Hospital

2014 ◽  
Vol 11 (6) ◽  
pp. 673-680 ◽  
Author(s):  
Michael Weisskopf ◽  
Guido Bucklar ◽  
Jürg Blaser
Keyword(s):  
Information System ◽  
Clinical Trials ◽  
Clinical Research ◽  
Hospital Admissions ◽  
Clinical Information System ◽  
Clinical Information ◽  
University Hospital ◽  
Trial Registry ◽  
Trial Participants ◽  
Year 2013

Background: Issues concerning inadequate source data of clinical trials rank second in the most common findings by regulatory authorities. The increasing use of electronic clinical information systems by healthcare providers offers an opportunity to facilitate and improve the conduct of clinical trials and the source documentation. We report on a number of tools implemented into the clinical information system of a university hospital to support clinical research. Methods: In 2011/2012, a set of tools was developed in the clinical information system of the University Hospital Zurich to support clinical research, including (1) a trial registry for documenting metadata on the clinical trials conducted at the hospital, (2) a patient–trial–assignment–tool to tag patients in the electronic medical charts as participants of specific trials, (3) medical record templates for the documentation of study visits and trial-related procedures, (4) online queries on trials and trial participants, (5) access to the electronic medical records for clinical monitors, (6) an alerting tool to notify of hospital admissions of trial participants, (7) queries to identify potentially eligible patients in the planning phase as trial feasibility checks and during the trial as recruitment support, and (8) order sets to facilitate the complete and accurate performance of study visit procedures. Results: The number of approximately 100 new registrations per year in the voluntary trial registry in the clinical information system now matches the numbers of the existing mandatory trial registry of the hospital. Likewise, the yearly numbers of patients tagged as trial participants as well as the use of the standardized trial record templates increased to 2408 documented trial enrolments and 190 reports generated/month in the year 2013. Accounts for 32 clinical monitors have been established in the first 2 years monitoring a total of 49 trials in 16 clinical departments. A total of 15 months after adding the optional feature of hospital admission alerts of trial participants, 107 running trials have activated this option, including 48 out of 97 studies (49.5%) registered in the year 2013, generating approximately 85 alerts per month. Conclusions: The popularity of the presented tools in the clinical information system illustrates their potential to facilitate the conduct of clinical trials. The tools also allow for enhanced transparency on trials conducted at the hospital. Future studies on monitoring and inspection findings will have to evaluate their impact on quality and safety.

scholarly journals Nurses and Clinical Research Coordinators (CRCs) collaboration to improve quality in clinical trials

2015 ◽  
Vol 26 ◽  
pp. vi108
Author(s):  
A. Zeneli ◽  
P. Serra ◽  
T. Rosanna ◽  
B. Marina ◽  
D. Andreis ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Improve Quality ◽  
Clinical Research Coordinators

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 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

Direct impact of clinical research in metastatic renal cell carcinoma (mRCC): A cost-effectiveness analysis of patient care outcomes and cost savings in a real-life scenario of a large public university hospital in Spain.

2019 ◽  
Vol 37 (7_suppl) ◽  
pp. 637-637
Author(s):  
Silvia Garcia-Garro ◽  
Pablo Gajate ◽  
Esther Gómez-de-Salazar ◽  
Teresa Alonso Gordoa ◽  
Miguel Angel Rodriguez-Sagrado ◽  
...  
Keyword(s):  
Public Health ◽  
Clinical Trial ◽  
Overall Survival ◽  
Clinical Trials ◽  
Clinical Research ◽  
Public Health System ◽  
Real Life ◽  
Cost Savings ◽  
University Hospital ◽  
Direct Impact

637 Background: Public health sustainability is a major concern worldwide. Clinical research is considered to leverage patient care outcome but also can lead costs savings and, subsequently, to maintain public health system. Thus, we analyzed the direct impact of clinical research in terms of improvement in clinical outcomes and costs related to research in patients with mRCC in real-life setting. Methods: We retrospectively collected data related to overall survival (OS) and direct health care costs from all mRCC patients who were treated with oral anti-tumour medication and followed at the Medical Oncology Department of Ramón y Cajal University Hospital in Madrid, between January 2010 and February 2017. A statistical analysis comparing the outcomes of patients included in clinical trials versus those not included was conducted. Results: In the study period, 65 patients were newly diagnosed with mRCC and received treatment. Those patients included in clinical trials showed higher median OS (91 vs. 29 months. HR 0.389; 95% CI: 0.150: 1.000; p=0.04). Median direct cost per mRCC patient in ‘real-life’ was €67,376. Median cost for a patient enrolled in at least one clinical trial was €53,673 vs. €63,834 for those who were never recruited for a trial. Participation in clinical trials contributed to a decrease in total health expenditure by 9.02% (€362,367), mainly due to reduction in the cost of medications and diagnostic tests (91.46% vs. 8.54%, respectively). Furthermore, clinical trial participants have required less number of hospitalizations (0.08 vs. 1.75) and emergency visits (0.39 vs. 3.2) per patient. Conclusions: Under the public health system perspective, participation in clinical trials is related to an improvement in overall survival as well as direct and indirect cost savings in mRCC patients.

scholarly journals Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials

2017 ◽  
Vol 8 ◽  
pp. 156-161 ◽  
Author(s):  
Noriko Fujiwara ◽  
Ryota Ochiai ◽  
Yuki Shirai ◽  
Yuko Saito ◽  
Fumitaka Nagamura ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Qualitative Analysis ◽  
Clinical Research ◽  
Phase I ◽  
Cancer Clinical Trials ◽  
Clinical Research Coordinators
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