scholarly journals Barriers to symptom management care pathway implementation in pediatric Cancer

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
L. Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators prior to randomization to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P = 0.003). Conclusions The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic may not be a major barrier to clinical research activities in pediatric oncology.

scholarly journals Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer

2020 ◽  
Author(s):  
L Lee Dupuis ◽  
Allison Grimes ◽  
Emily Vettese ◽  
Lisa M. Klesges ◽  
Lillian Sung
Keyword(s):  
Clinical Research ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Symptom Management ◽  
Care Pathway ◽  
The United States ◽  
Care Pathways ◽  
Research Activities ◽  
Pediatric Cancer Patients ◽  
The Impact

Abstract Background: To describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree.Results: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P=0.003). Conclusions: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic was not a major barrier to clinical research activities in pediatric oncology.Clinical Trial Registration: NCT04614662

scholarly journals Impact of COVID-19 on clinical trials and clinical research: A systematic review

2020 ◽  
Vol 10 (3) ◽  
pp. 878-887
Author(s):  
Brijesh Sathian ◽  
Mohammad Asim ◽  
Indrajit Banerjee ◽  
Ana Beatriz Pizarro ◽  
Bedanta Roy ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Clinical Research ◽  
Negative Impact ◽  
The United States ◽  
Sudden Onset ◽  
World Health ◽  
Research Activities ◽  
The World ◽  
The Impact

Background: The World Health Organization has reported more than 31,186,000 confirmed cases of coronavirus disease-19 (COVID-19), including 962,343 deaths, worldwide as on September 21, 2020. The current COVID-19 pandemic is affecting clinical research activities in most parts of the world. The focus on developing  a vaccine for SARS-CoV-2 and the treatment of COVID-19 is, in fact, disrupting many upcoming and/or ongoing clinical trials on other diseases around the globe. On March 18, 2020, the United States Food and Drug Administration (FDA) issued an updated guideline for the conduct of clinical trials during the current health emergency situation. The potential challenges, such as social distancing and quarantines, result in study participants’ inaccessibility and trial personnel for in-person scheduled study visits and/or follow-up. Due to the sudden onset and wide-spread impact of COVID-19, its influence on the management of clinical trials and research necessitates urgent attention. Therefore, our systematic review of the literature aims to assess the impact of the COVID-19 pandemic on the conduction of clinical trials and research. The search for the relevant articles for review included the keywords "COVID-19” AND "clinical trial" in PubMed, MEDLINE, Embase, Google scholar and Google electronic databases. Key findings include: delaying subject enrollment and operational gaps in most ongoing clinical trials, which in turn has a negative impact on trial programmes and data integrity. Globally, most sites conducting clinical trials other than COVID-19 are experiencing a delay in timelines and a complete halt of operations in lieu of this pandemic, thus affecting clinical research outcomes.

scholarly journals The Need for Shared Nomenclature on Racism and Related Terminology in Psychology

2021 ◽  
Vol 16 (5) ◽  
pp. 886-892
Author(s):  
Angela M. Haeny ◽  
Samantha C. Holmes ◽  
Monnica T. Williams
Keyword(s):  
Clinical Research ◽  
Negative Impact ◽  
Racial Microaggressions ◽  
The United States ◽  
Multiple Forms ◽  
Social Construct ◽  
Racial Hierarchy ◽  
The Social ◽  
The Many ◽  
The Impact

With the increased desire to engage in antiracist clinical research, there is a need for shared nomenclature on racism and related constructs to help move the science forward. This article breaks down the factors that contributed to the development and maintenance of racism (including racial microaggressions), provides examples of the many forms of racism, and describes the impact of racism for all. Specifically, in the United States, racism is based on race, a social construct that has been used to categorize people on the basis of shared physical and social features with the assumption of a racial hierarchy presumed to delineate inherent differences between groups. Racism is a system of beliefs, practices, and policies that operate to advantage those at the top of the racial hierarchy. Individual factors that contribute to racism include racial prejudices and racial discrimination. Racism can be manifested in multiple forms (e.g., cultural, scientific, social) and is both explicit and implicit. Because of the negative impact of racism on health, understanding racism informs effective approaches for eliminating racial health disparities, including a focus on the social determinants of health. Providing shared nomenclature on racism and related terminology will strengthen clinical research and practice and contribute to building a cumulative science.

Contract Clinical Research: A Rapidly Changing Marketplace

1996 ◽  
Vol 9 (6) ◽  
pp. 406-415
Author(s):  
Daniel Krichbaum ◽  
Alan Rosenthal
Keyword(s):  
Clinical Research ◽  
The United States ◽  
Considerable Change ◽  
Business Strategies ◽  
Quality Data ◽  
Scientific Integrity ◽  
Research Activities ◽  
Large Numbers ◽  
Research Organizations

Drug development in the United States has undergone considerable change over the past decade. The outsourcing of clinical research activities to Contract Research Organizations (CROs) continues to escalate in an attempt to speed drugs to market faster. The increasing use of business strategies at the investigational site level has fostered the emergence of specialty networks and Site Management Organizations (SMOs). SMOs offer pharmaceutical and biotechnology sponsors the ability to work with a tightly managed network of experienced professional multispecialty research centers that can enroll large numbers of patients and provide high quality data. While these organizations have fundamentally changed the way drugs are developed, they have also contributed to an acceleration of the process and an improvement in the scientific integrity and quality of the data.

scholarly journals 2069

2017 ◽  
Vol 1 (S1) ◽  
pp. 43-44
Author(s):  
Carlton Hornung ◽  
Carolyn Thomas Jones ◽  
Terri Hinkley ◽  
Vicki Ellingrod ◽  
Nancy Calvin-Naylor
Keyword(s):  
Clinical Research ◽  
Data Management ◽  
Core Competencies ◽  
Safety Data ◽  
The United States ◽  
Education And Training ◽  
Development Ethics ◽  
The Impact ◽  
And Training ◽  
Research Professionals

OBJECTIVES/SPECIFIC AIMS: Clinical research in the 21st century will require a well-trained workforce to insure that research protocols yield valid and reliable results. Several organizations have developed lists of core competencies for clinical trial coordinators, administrators, monitors, data management/informaticians, regulatory affairs personnel, and others. While the Clinical Research Appraisal Inventory assesses the self-confidence of physician scientists to be clinical investigators, no such index exists to assess the competence of clinical research professionals who coordinate, monitor, and administer clinical trials. We developed the Competency Index for Clinical Research Professionals (CICRP) as a general index of competency (ie, GCPs) as well as sub-scales to assess competency in the specific domains of Medicines Development; Ethics and Participant Safety; Data Management; and Research Methods. METHODS/STUDY POPULATION: We analyzed data collected by the Joint Task Force on the Harmonization of Core Competencies from a survey of research professionals working in the United States and Canada. Respondents reported how competent they believed themselves to be on 51 clinical research core competencies. Factor analyzes identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. RESULTS/ANTICIPATED RESULTS: Factor analysis identified 20 core competencies that defined a Competency Index for Clinical Research Professionals—General (CICRP-General, ie, GCPs) and 4 subindices that define specialized research functions: Medicines Development; Ethics and Participant Safety; Data Management; and Research Concepts. DISCUSSION/SIGNIFICANCE OF IMPACT: These indices can be used to gage an individual’s readiness to perform general as well as more advanced research functions; to assess the education and training needs of research workers; and to evaluate the impact of education and training programs on the competency of research coordinators, monitors, and other clinical research team members.

Pediatric Oncology Nurses' Attitudes Related to Discussing Fertility Preservation With Pediatric Cancer Patients and Their Families

2007 ◽  
Vol 24 (5) ◽  
pp. 255-263 ◽  
Author(s):  
Susan T. Vadaparampil ◽  
Heather Clayton ◽  
Gwendolyn P. Quinn ◽  
Lindsey M. King ◽  
Michael Nieder ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Fertility Preservation ◽  
Pediatric Oncology ◽  
Pediatric Cancer ◽  
Oncology Nurses ◽  
Pediatric Cancer Patients

scholarly journals The impact of clinical research activities on communities in rural Africa: the development of the Clinical Research Unit of Nanoro (CRUN) in Burkina Faso

2014 ◽  
Vol 13 (1) ◽  
pp. 113 ◽  
Author(s):  
Halidou Tinto ◽  
Innocent Valea ◽  
Hermann Sorgho ◽  
Marc Tahita ◽  
Maminata Traore ◽  
...  
Keyword(s):  
Clinical Research ◽  
Burkina Faso ◽  
Research Unit ◽  
Research Activities ◽  
Clinical Research Unit ◽  
Rural Africa ◽  
The Impact

scholarly journals The number, scope and geographic distribution of clinical researchers in Canada

2008 ◽  
Vol 31 (5) ◽  
pp. 222 ◽  
Author(s):  
Malathi Raghavan ◽  
J Dean Sandham
Keyword(s):  
Clinical Research ◽  
Geographic Distribution ◽  
Basic Research ◽  
Research Capacity ◽  
The United States ◽  
Research Grants ◽  
Principal Investigators ◽  
Randomized Controlled ◽  
Research Activities ◽  
The Ideal

Purpose: Despite international concerns about declining numbers of clinical researchers, the number of clinical researchers in Canada remains undocumented. Methods: The number and geographic distribution of clinical researchers in Canada and the scope of their research activities were estimated using, as an indicator, the data on clinical research projects funded by the Canadian Institutes for Health Research (CIHR). Results: Between fiscal years 1999-00 and 2006-07, 1,041 individual researchers—approximately 130 per year—were principal investigators (PIs) on clinical research grants. One hundred and 26 researchers received salary awards; 449 supervisors oversaw the clinical research activities of 230 fellows and 223 students with trainee awards. An additional 2,305 individuals served only as co-investigators on grants. Most (863 [83%]) PIs received funding for operating grants; 196 (19%) PIs received funding for randomized controlled trials. The institute of neurosciences, mental health and addiction funded the highest number of researchers (187 [18%] PIs, 40 [17%] fellows, and 73 [33%] students). Among provinces, Quebec led the nation with the highest number (45) of PIs per million population. Ontario had the highest number of clinical research fellows (10 per million population) while Quebec and Saskatchewan each hosted more students (11 per million). Conclusion: The number of Canadian investigators with funding for clinical research from CIHR was low. Although the ideal ratio of clinical to basic research capacity is not known, the possibility that the gap between laboratory-based research and clinical research is larger in Canada than in the United States is discussed.

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