The Role of the Clinical Trials Nurse. Objectives. CTN: Protocol Development

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1 The Role of the Clinical Trials Nurse Elizabeth Ness, RN, MS Director, Staff Development Center for Cancer Research, NCI Objectives Discuss the clinical trials nurse s involvement in protocol development. Discuss activities associated with study coordination. Analyze various activities related to oncology clinical trials management and what member of the research team may best be suited to carry out a specific activity. CTN: Protocol Development Protocol review Protocol writing Protocol implementation 1

2 CTN: Protocol Review When to review - time points What to review Implementation aspects Discrepancies Informed Consent document Impact of CTN input CTN: Protocol Writing Use of templates What sections appropriate for CTN to write CTN: Protocol Implementation Assist with screening, enrollment, and medical evaluations Review clinical laboratory findings and make correlations with clinical events Manage reporting of adverse events Oversee clinical aspects of study Conduct clinical rounds Direct patient care 2

3 What is a Clinical Research Coordinator (CRC)? Specialized research professional Manages daily operations of a clinical investigation Works with and under the direction of the PI whose research activities are conducted under Good Clinical Practice (GCP) Plays a critical role in the study conduct Has a wide range of responsibilities Advantages of having a CRC Increase recruitment rate Enhancement of retention Good data quality Increases general study efficiency Research Team Members Principal Investigator Associate, Sub, or Co-investigators Statistician Research Nurse/Clinical Trials Nurse Study Coordinator/Clinical Research Coordinator Data Manager Participant/Subject Support Staff 3

4 All staff involved in clinical research must adhere to the regulations and understand the guidelines that govern clinical research. CRC Responsibilities: Overview Advocacy Feasibility assessment Informed Consent Study management Documentation Education CRC s Role in Human Subjects Protection Patient advocacy Patient s welfare Subject advocacy Rights and welfare of individuals as research subject Study advocacy Advancing research goals Gather valid, clean data Roles must be balanced Davis et al,

5 Feasibility Assessment Review protocol while under development Review eligibility requirements Assess ability to meet study milestones Assess resources necessary to conduct the study (personnel, physical space, and materials ) Assess financial feasibility Informed Consent Process Interact with the investigator, sponsor (if appropriate) and/or IRB on informed consent wording issues Review informed consent document for quality and completeness Obtain informed consent Coordinate the re-consent process as needed Study Management Maintain integrity of the protocol Recruit, contact and screen potential subjects Schedule subject visits Prepare for each subject visit Assist investigator with study subject visits Collaborate with other departments as necessary and participate in problem solving 5

6 Study Management Documentation Patient data Deviations & violations Ensure that all necessary data are gathered and recorded in the appropriate case report forms Review case report form entries for completeness, appropriateness and logic Develop data QA/AC plan(s) Study Management Schedule sponsor visits Work with monitors during monitoring visits Ensure drug/device accountability Reorder study supplies as necessary Assist investigator with financial aspects of the trial, including budgeting/contracts, and payments to study subjects, Complete study closeout activities Education Patient/Subject Disease Clinical Trials & Research: phases, patient role Importance of compliance with treatment and procedures Specific protocol for patient Study objectives Schema: calendars & visual aids Side effects & management Expectations for patient cure, control, palliation or no benefit? 6

7 Education Support staff Schedule in-services for all appropriate nursing units Present information in a concise manner focusing on what the clinical nurses need to know (drug administration and PKs) Provide worksheets, as appropriate Keep staff informed about amendment and general protocol progress Education Self Know your protocol basics Know your diseases being studied Be your own advocate Protect your time & get organized Learn as much as you can about: clinical trials, oncology, your particular drug(s), your database/software programs Know how/where to get training & do it Join a professional organization & get involved 7

8 Reference List ACRP FDA CRC Certification Guide (North America), ( Accessed September 2, ACRP ICH CRC Certification Guide Guide.pdf. Accessed September 2, Anderson, G. (2008). Ethical Preparedness and Performance of Gene Therapy Study Co-ordinators. Nursing Ethics, 15(2) Bird, J. & Kirshbaum (2005). Towards a framework of advanced nursing practice for the clinical research nurse in cancer care. Clinical Effectiveness in Nursing, 6, Davis, A.M., Hull, S.C., Grady, C., Wilfond, B.S., Henderson, G.E. (2002). The Invisible Hand in Clinical Research: The Study Coordinator s Critical Role in Human Subjects Protection. Journal of Law, Medicine & Ethics, 30, Fedor, C. & Cola, P. (2003). Preliminary Results of the Clinical Researcher Coordinators Survey. Clinical Researcher, 3(4), 2-6. McCabe, M. & Lawrence, C.A. (2007). Viewpoint: The Clinical Research Nurse. American Journal of Nursing, 107 (9), 13. Rico-Villademoros, F., Hernando, T., Sanz, J.L., Lopez-Alonso, A., Salamanca, O., Camps, C., Rafel Rossel (2004). The role of the clinical research coordinator data manager in oncology clinical trials. BMC Medical Research Methodolody, 4, 614. Spilsbury, K., Petherick, Cullum, N., Nelson, A., Nixon, J., Mason, S. (2007). The role an dpotential contribution of clinical research nurses to clinical trials. Journal of Clinical Nursing, 17,

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