Starting a Clinical Research Team

2018 ◽  
pp. 27-36
Author(s):  
Cara East
Keyword(s):  
Clinical Research ◽  
Research Team

Abstract TP292: Effect of Improved Management Strategies on Study Retention Rates

Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Michael Dela Cruz ◽  
Kinga Aitken ◽  
Ka-Ho Wong ◽  
Theodore Rock ◽  
Jennifer J Majersik
Keyword(s):  
Clinical Research ◽  
Research Team ◽  
Retention Rate ◽  
Management Strategies ◽  
Retention Rates ◽  
Stroke Patients ◽  
Trial Duration ◽  
Implementation Period ◽  
Stroke Center ◽  
Stroke Trial

Introduction: Average national dropout rates of participants enrolled in a research trial are reported to be 30%. Factors contributing to loss of stroke patient retention include the lack of understanding of study expectations, lack of relationship building between patient and clinical research team, and inefficient management processes. There has been little research into interventions to improve retention. Focusing on these 3 factors may increase the likelihood of stroke patients adhering to and completing participation in stroke trials. The University of Utah Stroke Center became a StrokeNet regional coordinating center in October 2013. As study trials increased, we recognized the need to implement new trial management strategies and did so in January 2016. Methods: Stroke trial metrics were compared between the pre-implementation period (7/1/2012 - 12/31/2015) and a post-implementation period (1/7/2016 - 7/1/2019). The size of clinical research team personnel remained the same across the two periods: 4 coordinators and 9 physicians. Standardization of enrollment processes in stroke trials occurred during the post-implementation period. Three key aspects addressed in the post-implementation period were building rapport, setting realistic expectations, and properly educating patient and family members. The clinical research team incorporated these factors when approaching patients regardless of type of stroke trial (acute, subacute, or observational). Results: During the pre-implementation period, the Stroke Center research team managed 8 stroke studies with 52 patients consented with average trial duration of 23 months (SD); in the post-implementation period, there were 15 studies with 99 patients consented, with average trial duration of 22 months (SD). Retention improved after the intervention from a mean (SD) retention rate of 79.5 (29.7) %. to 90.8 (17.2) %. Although this difference was not significant, it represented meaningful change to the research staff and helped us achieve StrokeNet retention goals. Conclusion: Implementation of effective management strategies leads to higher retention rates of stroke patients despite no change in the size of the clinical research team.

Clinical Nurses Experience with being on a Clinical Research Team

2019 ◽  
Vol 34 (4) ◽  
pp. e28-e29
Author(s):  
Elizabeth Card ◽  
Shannon Brooks ◽  
Clayton Freemen ◽  
Christy Loyd ◽  
Adesinasi Wuraola ◽  
...  
Keyword(s):  
Clinical Research ◽  
Research Team ◽  
Clinical Nurses

scholarly journals Research-Embedded Health Librarians as Facilitators of a Multidisciplinary Scoping Review

2017 ◽  
Vol 38 (2) ◽  
pp. 38-43 ◽  
Author(s):  
Gina Brander ◽  
Colleen Pawliuk
Keyword(s):  
Clinical Research ◽  
Scoping Review ◽  
Research Team ◽  
Workflow Management ◽  
Large Data ◽  
Data Sets ◽  
Team Members ◽  
Geographically Dispersed ◽  
Program Objective ◽  
High Level

Program  objective:  To  advance  the  methodology  and  improve  the  data  management  of  the  scoping  review through  the  integration  of  two  health  librarians  onto  the  clinical  research  team.  Participants  and  setting:  Two  librarians were  embedded  on  a  multidisciplinary,  geographically  dispersed  pediatric  palliative  and  end-of-life  research  team  conducting a  scoping  review  headquartered  at  the  British  Columbia  Children’s  Hospital  Research  Institute.  Program:  The  team’s embedded  librarians  guided  and  facilitated  all  stages  of  a  scoping  review  of  180  Q3  conditions  and  10  symptoms.  Outcomes: The  scoping  review  was  enhanced  in  quality  and  efficiency  through  the  integration  of  librarians  onto  the  team.  Conclusions: Health  librarians  embedded  on  clinical  research  teams  can  help  guide  and  facilitate  the  scoping  review  process  to  improve workflow  management  and  overall  methodology.  Librarians  are  particularly  well  equipped  to  solve  challenges  arising  from large  data  sets,  broad  research  questions  with  a  high  level  of  specificity,  and  geographically  dispersed  team  members. Knowledge  of  emerging  and  established  citation-screening  and  bibliographic  software  and  review  tools  can  help  librarians  to address  these  challenges  and  provide  efficient  workflow  management. 

scholarly journals Leadership Lessons: Building and Nurturing a High‐Performing Clinical Research Team

2018 ◽  
Vol 66 (7) ◽  
pp. 1258-1261 ◽  
Author(s):  
Una E. Makris ◽  
Lauren E. Ferrante ◽  
Lona Mody
Keyword(s):  
Clinical Research ◽  
Research Team ◽  
High Performing ◽  
Leadership Lessons

scholarly journals Subversive Subjects: Rule-Breaking and Deception in Clinical Trials

2013 ◽  
Vol 41 (4) ◽  
pp. 829-840 ◽  
Author(s):  
Rebecca Dresser
Keyword(s):  
Clinical Trials ◽  
England Journal ◽  
Clinical Research ◽  
New England ◽  
Research Team ◽  
Research Subjects ◽  
Study Participation ◽  
Population Number ◽  
Rule Breaking ◽  
Hiv Aids

Scientific reports about clinical research appear objective and straightforward. They describe a study's findings, methods, subject population, number of subjects, and contribution to existing knowledge. The overall picture is pristine: the research team establishes the requirements of study participation and subjects conform to these requirements. Readers are left with the impression that everything was done correctly, by the book.In other places, however, one finds a different and messier picture of clinical research. In this picture, research subjects deviate from the prescribed plan. One author contrasted the “tidy graphics” and “crisp prose” of the New England Journal of Medicine's HIV/AIDS trial publications with reports that subjects shared medications and broke other trial rules. Awareness of this behavior, he wrote, could lead insiders to “conclude that knowledge was resting on something rather less solid than bedrock.”

scholarly journals Resolving Rivalries and Realigning Goals: Challenges of Clinical and Research Multiteam Systems

2016 ◽  
Vol 12 (11) ◽  
pp. 1020-1028 ◽  
Author(s):  
David E. Gerber ◽  
Torsten Reimer ◽  
Erin L. Williams ◽  
Mary Gill ◽  
Laurin Loudat Priddy ◽  
...  
Keyword(s):  
Clinical Research ◽  
Collective Identity ◽  
Research Team ◽  
Clinical Care ◽  
Multidisciplinary Teams ◽  
Clinical Team ◽  
Team Members ◽  
Multiteam Systems ◽  
Care Processes ◽  
High Level

This article describes the care processes for a 64-year-old man with newly diagnosed advanced non–small-cell lung cancer who was enrolled in a first-line clinical trial of a new immunotherapy regimen. The case highlights the concept of multiteam systems in cancer clinical research and clinical care. Because clinical research represents a highly dynamic entity—with studies frequently opening, closing, and undergoing modifications—concerted efforts of multiple teams are needed to respond to these changes while continuing to provide consistent, high-level care and timely, accurate clinical data. The case illustrates typical challenges of multiteam care processes. Compared with clinical tasks that are routinely performed by single teams, multiple-team care greatly increases the demands for communication, collaboration, cohesion, and coordination among team members. As the case illustrates, the described research team and clinical team are separated, resulting in suboptimal function. Individual team members interact predominantly with members of their own team. A considerable number of team members lack regular interaction with anyone outside their team. Accompanying this separation, the teams enact rivalries that impede collaboration. The teams have misaligned goals and competing priorities that create competition. Collective identity and cohesion across the two teams are low. Research team and clinical team members have limited knowledge of the roles and work of individuals outside their team. Recommendations to increase trust and collaboration are provided. Clinical providers and researchers may incorporate these themes into development and evaluation of multiteam systems, multidisciplinary teams, and cross-functional teams within their own institutions.

scholarly journals Orthopaedic clinical research: building a team that lasts

2021 ◽  
Vol 6 (4) ◽  
pp. 245-251
Author(s):  
Laura Stiegel ◽  
Alison K. Klika ◽  
Carlos A. Higuera ◽  
Wael K.Barsoum ◽  
Nicolas S. Piuzzi
Keyword(s):  
Clinical Research ◽  
Time Management ◽  
Orthopaedic Surgery ◽  
Research Team ◽  
Team Building ◽  
Research Programme ◽  
Research Setting ◽  
Quality Research ◽  
Medical Progress

Medical progress, including in the orthopaedic surgery field, depends on the interaction and collaboration between: physicians, with their expertise on the clinical setting; scientists, with their expertise on the research setting; and professionals who are skilled in both settings (clinical scientists). This leads to the need to develop research approaches which involves people who are committed and support the process, strategic planning, and a cohesive team that can execute the tasks. All these interactions must be supported financially in order to maintain the long-term viability of such team. Time management is crucial for the clinical research team. To ensure success, the research team must be flexible in order to adapt to dynamic clinical and surgical schedules. It is especially important that surgeons have regular, dedicated quality research time to maintain a consistent interaction with the team. Building a successful and productive orthopaedic clinical research programme involves many challenges in creating proper leadership, obtaining funding, setting proper resources, establishing necessary training, and providing guidance and insight around the importance of each role that every member plays on the team. Cite this article: EFORT Open Rev 2021;6:245-251. DOI: 10.1302/2058-5241.6.200058

scholarly journals The Critical Role of the Clinical Research Coordinator for Clinical Trials: A Survey in Oncology

2017 ◽  
Vol 1 ◽  
pp. maapoc.0000015 ◽  
Author(s):  
Margherita Cinefra ◽  
Celeste Cagnazzo ◽  
Laura McMahon ◽  
Francesca Arizio ◽  
Sara Campora ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Clinical Research ◽  
Clinical Studies ◽  
Research Team ◽  
Critical Role ◽  
Strong Support ◽  
Web Survey ◽  
Clinical Research Coordinator ◽  
Research Activities ◽  
Research Coordinator

Introduction Access to innovative medicine requires proper evidence from clinical trials with the growing demand of qualified and experienced personnel. The clinical research coordinator (CRC) plays an important role in the conduction of research activities and provides a strong support to the research team. In Italy, this role is not recognized at any institutional level and its professional outline is still indefinite. Several national associations (Associazione Italiana di Oncologia Medica, Collegio Italiano dei Primari Oncologi Medici Ospedalieri, Gruppo Italiano Data Manager) are committed to promoting the enhancement and recognition of the professional status of CRCs, underlining their role as fundamental. Methods A web survey, proposed by the AIOM CRC Working Group, was submitted to 319 Italian oncology sites with items focusing on the organization of sites, the research activities, the staff composition, and the presence of coordinators and the multidisciplinary team. Results A total of 115 sites (35.9%) responded to the web survey. Clinical studies were carried out at 88.7% of the investigated sites, and coordinators were on staff at 75.5% of the active investigational sites. Interestingly, there was a direct association between the number of clinical studies and the number of coordinators, whose contribution to the research activities is believed to be essential for trial conduct in 82.4% of cases. Most sites retain that the quality of clinical research has absolutely improved (83.3%) after the implementation of a coordinator as member of the team. Conclusions Given the constant growth of the number of clinical trials performed at Italian oncology sites, the CRC proves to be an essential component of the research team. However, there is an urgent need to institute the professional role alongside the need to standardize the training of coordinators to establish the minimum requirements enhanced by qualifying courses.

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