A collaborative model for training clinical research staff

Background/Aims Essential to bringing innovative cancer treatments to patients is voluntary participation in clinical trials but approximately 8% of American cancer patients are enrolled onto a trial. We used a domain-oriented framework to assess barriers to cancer clinical trial enrollment. Methods Physicians (MD, DO, fellows, residents) and research staff (physician assistants, nurse practitioners, staff and research nurses, clinical assistants, and program coordinators) involved in clinical research at a comprehensive cancer center completed an online survey in 2017; adult cancer patients not currently enrolled in a trial were interviewed in 2018. To inform the construct of our physician/staff and patient surveys and to assess barriers to clinical trial enrollment, we first conducted in-depth interviews among 14 key informants representing medical, hematologic, gynecologic, neurologic, radiation oncology, as well as members of the clinical research team (one clinical research coordinator, one research nurse practitioner). Perceived structural, provider- and patient-level barriers to clinical trial enrollment were assessed. Differences in perceptions, attitudes, and beliefs toward clinical trial enrollment between (1) physicians and staff, (2) patients by ethnicity, and (3) physicians/staff and patients were examined. Results In total, 120 physicians/staff involved in clinical research (39.2% physicians, 60.8% staff; 48.0% overall response rate) and 150 cancer patients completed surveys. Nearly three-quarters of physician/staff respondents reported difficulty in keeping track of the eligibility criteria for open studies but was more often cited by physicians than staff (84.4% vs 64.3%, p = 0.02). Physicians more often reported lack of time to present clinical trial information than did staff( p < 0.001); 44.0% of staff versus 18.2% of physicians reported patient family interaction as a clinical trial enrollment barrier ( p = 0.007). Hispanic patients more often stated they would join a trial, even if standard therapy was an option compared to non-Hispanic patients (47.7% vs 20.8%, p = 0.002). Comparing the beliefs and perceptions of physicians/staff to those of patients, patients more often reported negative beliefs about clinical trial enrollment (e.g. being in a trial does not help patients personally, 32.9% vs 1.8%, p < 0.001) but less often felt they had no other options when agreeing to join (38.1% vs 85.6%, p < 0.001), and less often refused clinical trial enrollment due to lack of understanding (9.1% vs 63.3%, p = 0.001) than reported by physicians/staff. Conclusion Our findings indicate a wide gap between physician/staff and patient attitudes and beliefs about clinical trial enrollment and highlight the importance of focusing future initiatives to raise awareness of this incongruency. Reconciling these differences will require tailored education to reduce implicit biases and dispel misperceptions. Strategies to improve the quality of patient–provider communication and address infrastructure and resource issues are also needed to improve patient enrollment onto cancer clinical trials.

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Teaching statistics to clinical research staff in a pharmaceutical company

Pharmaceutical Statistics ◽

10.1002/pst.208 ◽

2006 ◽

Vol 5 (3) ◽

pp. 225-229 ◽

Cited By ~ 5

Author(s):

Sunil K. Dhar ◽

Farid Kianifard

Keyword(s):

Clinical Research ◽

Pharmaceutical Company ◽

Research Staff ◽

Teaching Statistics

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Competency-Based Training System for Clinical Research Staff

Principles and Practice of Pharmaceutical Medicine ◽

10.1002/0470846291.ch3 ◽

2003 ◽

pp. 17-28

Author(s):

Jay D. Miller

Keyword(s):

Clinical Research ◽

Training System ◽

Research Staff ◽

Competency Based

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Cancer center clinic and clinical research team perceptions of identity and interactions.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e18215 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e18215-e18215

Author(s):

David E. Gerber ◽

Torsten Reimer ◽

Sandra Garcia ◽

Mary Gill ◽

Tobi Duncan ◽

...

Keyword(s):

Clinical Trials ◽

Clinical Research ◽

Information Sharing ◽

Care Delivery ◽

Clinical Care ◽

The Other ◽

Cancer Center ◽

Cancer Clinical Trials ◽

Research Staff ◽

Clinic Staff

e18215 Background: As evidenced by the NCI-ASCO Teams in Cancer Care Delivery initiative, there is growing interest in applying an emerging science of teams to oncology clinical care. Treatment of patients on cancer clinical trials requires coordination and cooperation among research and clinic teams. However, little empirical research has examined issues of goal alignment, diffusion of responsibility, and perceived rivalries in this setting. Methods: We developed a survey incorporating modified components of the Adapted Team Climate Inventory, the Measure of Team Identification, and the Measure of In-group Bias. Surveys were administered to research staff and clinic staff. Survey responses were analyzed using t tests and ANOVAs. Results: Responses were received from 104 staff (54 clinic, 50 research). Median duration of professional experience was 8.3 years, and median time in current position was 2.0 years. Research staff identified more strongly with their own group ( P< 0.01) but less strongly with the Cancer Center ( P= 0.02) compared to clinic staff. Both clinic and research staff viewed their own group’s goals as clearer than those of the other group ( P< 0.01). Both clinic staff and research staff felt that members of their groups shared information among themselves more than the other group ( P< 0.01). Research staff felt information sharing occurred to a greater extent in both groups than did clinic staff ( P< 0.01). Similar results were noted regarding information sharing with the other group ( Ps< 0.01). Staff indicated that members of their own groups interacted more often with each other than did members of the other group ( P< 0.01), with research staff perceiving higher interaction rates in both teams than clinic staff ( P< 0.01). Research staff perceived daily outcomes to be more important than did clinic staff ( P =0.05), in particular research-related outcomes ( P =0.07). Conclusions: Clinical research staff and clinic staff identify more strongly with their own groups and feel that their own group’s goals are clearer than those of the other group. Further study of interactions, perceptions, and attitudes between research staff and clinic staff is essential to provision of quality care to patients on cancer clinical trials.

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A retrospective pilot study comparing data from monitoring reports to identify staffing influence on protocol deviation rates

International Journal of Clinical Trials ◽

10.18203/2349-3259.ijct20180128 ◽

2018 ◽

Vol 5 (1) ◽

pp. 30

Author(s):

Carolynn Jones ◽

Cheryl Fisher ◽

Catherine A. Griffith ◽

Joy Bailey ◽

Candida Barlow ◽

...

Keyword(s):

Pilot Study ◽

Adverse Events ◽

Clinical Research ◽

Statistical Significance ◽

Guidance Document ◽

Research Activity ◽

Research Staff ◽

Protocol Deviation ◽

Delegation Of Authority ◽

Research Activities

Background: Clinical research sites are hiring more non-licensed personnel to coordinate clinical trials and to replace licensed nurse counterparts. Revised regulatory documents heavily emphasize research staff training and research activity delegation of authority. The Scope and Standards of Practice for Clinical Research Nursing, published by the American Nurses’ Association and based on role delineation studies for nurses, is the guidance document for clinical research nurses participating in research activities. Policy making related to research activity delegation of authority would be informed by data that correlate protocol deviation rates with licensure and education of research staff. Protocol deviations can lead to invalid clinical trial results, adverse events, and ethical concerns related to participant risk exposure. Outcome data are lacking, which directly compare frequency of protocol deviations by licensed nurse study coordinators to deviation rates of non-licensed study coordinators.Methods: This pilot study reviewed 45 monitoring reports for 3 clinical research studies and associated research sites staffed with licensed RN study coordinators and research sites staffed with non-licensed, non-RN study coordinators to compare deviation rates related to informed consent, protocol endpoints, participant eligibility and adverse events.Results: We identified 101 deviations. Adverse event and endpoint deviations were the highest frequency. Differences were evident in overall deviation rates; however, specific deviation comparisons failed to show statistical significance due to low sample size. Conclusions: This study illustrates a useful method for planning future studies using monitoring reports for deviation tracking and comparison across staffing levels.

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