Role of the Oncology Research Team

Carmen B. Jacobs, BS, RN,OCN, CCRP

U.T.M.D. Anderson Cancer Center

Houston, Texas U.S.A.

2003 ASCO Study

• An ASCO study completed in 2003: – Physicians account for 9% of overall time required

to conduct a clinical trial– Nurses account for about 30%– Data managers for about 30%– CRA (may or may not be a nurse)

Principal Investigator• Oversees all aspects of the clinical trial– Protocol design– Recruitment– Data collection– Analysis and interpretation of results

Some tasks can be and are delegated….

SuccessfulClinical

Trial

PrincipalInvestigator

Collaborators

Data Management

Pharmacy

Sponsor

Regulatory

Nursing

The Research Team

The P.I. is responsible for ensuring all research team members have appropriate education, training and qualifications to assume the delegated tasks.

The Research Team

All study team members are responsible for ensuring that the conduct of the study is compliant with institutional, state, federal and industry guidance and regulations.

Collaborators (Sub or Co-Investigator)

Responsibilities:oMay perform all or some of the PI functionso Does not have primary responsibility for the

research studyo Under the supervision of the PIo Responsible for performing study-related

proceduresoMakes important study-related decisions in

compliance with the ethical conduct of the study

Investigational Pharmacy

ResponsibilitiesoProper storage and handling of study drugsoPreparation of study drugsoDispensing study drugsoStudy drug accountabilityo study drug destruction/return according to sponsor

and/or institution’s guidelines

Infusion Nurse

Responsibilitieso Administers the medication as ordered by

physician, according to protocol o Documents administration of medication,

including start and stop dates and timeo Assesses and documents patient’s side effects,

adverse eventso Patient teaching on side effects

Regulatory Coordinator

Responsibilities:o Drafting or editing the protocol document and

submitting new protocols, amendments, continuing (annual) reviews and safety reports to the IRB for review

oMaintaining regulatory binders in accordance with sponsor specifications and general industry standards

o Keeps delegation of authority (responsibilities) log

Data Coordinator

Responsibilities:o Overall data management of the research studyo Ensure accurate and timely data entry in

electronic databases, electronic case report forms (eCRFs) or paper case report forms (CRFs)

oWorks closely with monitors and resolves any data queries that may be generated

oWorks closely with the research team in identifying key data points for collection and analysis and generating reports

Research Nurse

Responsibilitieso Coordinates the daily activities of clinical research

studiesoWorks closely with the clinical team and

investigator to ensure that all protocol required procedures and visits occur according to protocol specific guidelines

oManages participant enrollmento Ensures compliance with protocol and other

applicable regulations

Research Nurse

• Ensures compliance:– Participant recruitment– Obtaining informed consent– Educating participants in the details of the

research study– Assesses participant’s eligibility– Facilitates participant’s care and follow-up per

protocol– Creates source documentation

Research Nurse

• Ensures compliance:– Assists in the assessment of the toxicities/adverse

events and reporting serious adverse events per IRB and sponsor requirements

– Teaches patient about prompt reporting of any new symptoms, side effects, adverse events

Clinical Research Associate

• May or may not be a nurse• Responsibilities vary – Regulatory compliance– Data management– “research nurse”

CRA / RN

• Main source of interaction with patients on study• Influence patient enrollment • Establishment of trust• Speak the “language” of the patient• Responsibilities vary according to his/her role

A Multidisciplinary Approach

• To increase awareness of clinical trials as treatment options

• Increase participation• Increase patient’s trust in the system

Participant

–Responsibilities:• Voluntary informed consent• Keep the protocol required doctor visits, tests, etc.• Report any side effects or new symptoms• Communicate with research staff (nurse, study

coordinator, etc.)

Good Clinical Practice

Remember:• The participant is the reason to conduct the clinical

trial

• Per WHO Guidelines for Good Clinical Practice:“To protect the rights, safety, and well-being of

humans participating in clinical research”

GRACIAS