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Clinical Trials Competencies

  • 1.  Clinical Trials Competencies

    Posted 08-10-2019 09:25
    Has anyone utilizing the competencies created a pre and/or post test to evaluate the learning from the competencies?

    Elyce Turba MSN RN
    Clinical Research Nurse
    H Lee Moffitt Cancer Center
    Tampa FL

  • 2.  RE: Clinical Trials Competencies

    Posted 08-12-2019 12:06
    Hi. The following included the Oncology Nursing Society Clinical Trials Nurse Competencies and evaluations involved pre/post knowledge tests:


    O-4 Training Community Cancer Centers to Implement Cancer Trials
    Robin Hermann2 • Regina Cunningham2 • Marcia Grant1 • Denice Economou1 • Marisa Cortese3, M. Grant, D. Economou, City of Hope, Duarte, California, UNITED STATES; R. Hermann, R. Cunningham, Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, UNITED STATES; M. Cortese, White Plains Hospital, White Plains, New York, UNITED STATES
    Purpose: Advancing the science of cancer treatment and improving cancer morbidity and mortality relies on conducting clinical trials. The purpose of this program was to administer a curriculum to train nurses and administrators from community-based cancer programs to implement clinical trials and accrue, treat and assess subjects.
    Background & Significance: The curriculum was built in response to the revised American College of Surgeons Commission on Cancer, Cancer Program Standard 1.9. The content included the Oncology Nursing Society Clinical Trials Nurse Competencies, the International Conference on Harmonization Good Clinical Practices, the Institute of Medicine report on building a clinical trials system for the 21st Century, and the Code of Federal Regulations.
    Conceptual or Clinical Model/Philosophic or Theoretic Framework: The curriculum developed by investigators and clinical trial experts using teaching methods that were based on adult learning principles and included lecture, discussion, small group work, and individual participation activities.
    Methods & Analysis: The training program covers the fundamentals of implementing a cancer clinical trials program and managing trial patients. Separate workshops were held for administrators and nurses, and focused on specific aspects of their roles in cancer trials. The workshops included documentation of research activity, resource allocation and patient and documentation management. Evaluations involved pre/post knowledge tests and course and faculty evaluations. Four monthly follow up conference calls provided support post course. Goals developed by each participant with course faculty were followed at 6, 12, and 18 months post course.
    Findings & Implications: Seven courses were held and included 275 participants from North America. Faculty evaluations and overall course evaluationscores were above 4 with 5 being the highest score. Nurse and administrator knowledge scores showed an increase from pre-test to post-test. Participation in the program has afforded attendees the opportunity to learn about clinical trials implementation and interact with other professionals from institutions across the nation during and following the workshop.
    Discussion: The interactive curriculum teaching methods were well received, and increases in knowledge by participants occurred. As goal follow up and analysis is completed, we will be able to identify what institutional changes have occurred and whether we have made an impact on increasing accrual and maintenance of patients to clinical cancer trials, these are the ultimate outcomes of the investigation.

    Mark Vrabel
    Oncology Nursing Society
    Pittsburgh PA

  • 3.  RE: Clinical Trials Competencies

    Posted 09-21-2019 10:40
    Send me your e-mail and I will try to hook you up with a clinical trials manager that I know.  She works with a bunch of one and done trials.