Emerging role of clinical trials assistants (CTAs) – integrating clinical research into standard care

Lung Cancer ◽  
2018 ◽  
Vol 115 ◽  
pp. S14-S15
Author(s):  
C. Fixmer ◽  
M. Lane ◽  
B. Johnson ◽  
S. Chee ◽  
J. Walters ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Standard Care

scholarly journals Beyond clinical trials: Extending the role of the clinical research nurse into social care and homeless research

2021 ◽  
Author(s):  
Elizabeth Biswell R ◽  
Michael Clark ◽  
Michela Tinelli ◽  
Gillian Manthorpe ◽  
Joanne Neale ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Social Care ◽  
Research Nurse

Community Equipoise and the Architecture of Clinical Research

1997 ◽  
Vol 6 (4) ◽  
pp. 385-396 ◽  
Author(s):  
Jason H. T. Karlawish ◽  
John Lantos
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Clinical Research ◽  
Standard Care ◽  
Human Services ◽  
Safety And Efficacy ◽  
Medical Progress ◽  
Essential Condition ◽  
Health And Human Services ◽  
Development Proceeds

Equipoise is an essential condition to justify a clinical trial. The term, describes a state of uncertainty: the data suggest but do not prove a drug's safety and efficacy The only way to resolve this uncertainty is further study In many cases, a clinical trial seems to be the most efficient way to prove safety and efficacy Equipoise is therefore not an esoteric philosophic construct applied to research ethics. Rather, since it is vital for the justification of clinical trials, it is part of how society regulates medical progress. Where there is equipoise, drug design and development proceeds according to Food and Drug Administration (FDA) and Health and Human Services (HHS) regulations. When that equipoise ends, a drug is either not approved or becomes standard care.

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.

The role of clinical research nurses in minority recruitment to cancer clinical trials

2021 ◽  
pp. 106590
Author(s):  
Kristen A. Legor ◽  
Laura L. Hayman ◽  
Janice B. Foust ◽  
Meghan L. Blazey
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Cancer Clinical Trials ◽  
Minority Recruitment ◽  
Research Nurses

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 The evolving role of people with MS in clinical research—Some progress but more is needed

2017 ◽  
Vol 23 (12) ◽  
pp. 1579-1582 ◽  
Author(s):  
Kathryn Smith
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trials ◽  
Research And Development ◽  
Clinical Research ◽  
Development Process ◽  
Relapsing Remitting ◽  
Do So

People with multiple sclerosis (MS) have been participants in clinical trials over many years, enabling the development and approval of many treatments for relapsing-remitting MS. Today, people with MS expect to be active collaborators in clinical trials and throughout the research and development process. Researchers and clinicians can benefit from including people with MS in all aspects of research and trials, and are urged to do so, so that we can move forward more quickly in developing needed treatments for progressive MS.

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