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Clinical Trial Overview

The National Cancer Institute's Cooperative Groups consist of researchers at member institutions who jointly develop and conduct cancer treatment clinical trials. In conjunction with national priorities for cancer treatment research, Groups generate new trials based on their particular areas of interest and expertise.

Cooperative Groups are diverse in their research objectives and their structures. There are three major types of Groups:

• Groups that are specifically disease oriented (e.g., gynecologic oncology)
• Groups that are designed to deal primarily with specific types of interventions (e.g., adjuvant therapy, radiation therapy, surgical therapy)
• Multimodality Groups that work in diverse cancer types with different specialists

All Groups are similar in that they develop and conduct large-scale, multi-institutional trials.

Most Groups are also affiliated with NCI's Community Clinical Oncology Programs (CCOP) whose research teams are based in community hospitals and practice sites.

Study Staff Roles and Responsibilities

Members of the site research team usually include at least one of the following: Principal Investigator, Clinical Research Associate (CRA) or Research Nurse, and Pharmacist. Each member of the study team has roles and responsibilities defined by the Code of Federal Regulations (CFR), Good Clinical Practice, and the individual Cooperative Groups. CTSU adheres to these regulations and guidelines with several additional responsibilities regarding data reporting.

The National Institutes of Health (NIH) has mandated education on human subject participation for all investigators and research team members who apply for or receive NIH funds for research involving people. Each research team member must document completion of training in human subjects protection. An online, NCI-developed continuing education program is availabe to fulfill this requirement. This course is available from the CTSU Registered Members Website or at: http://cme.nci.nih.gov.

Research team members and tasks are highlighted below. Though select tasks are delegated to the CRA, Research Nurse, or Pharmacist, the Principal Investigator is ultimately responsible for the research conducted at the site.

Principal Investigator

The Principal Investigator (PI) is responsible for the overall conduct of research activities at the site. The PI is expected to comply with the CFR and the International Conference on Harmonisation Guidelines for Good Clinical Practice. By signing the FDA 1572 Form, the PI agrees to:

• Submit initial protocol to the local IRB.
• Submit all amendments to the local IRB.
• Comply with IRB continuing review requirements.
• Report promptly to the IRB all changes in research activity and all unanticipated problems involving risks to patients or others. No changes in the research are made without IRB approval except when necessary to eliminate apparent immediate hazards to patients, with IRB notification immediately following elimination of the hazard.
• Conduct study in compliance with the protocol requirements.
• Manage the oversight of data and materials submitted to the CTSU and Cooperative Groups.
• Inform all patients of the investigational nature of the study and ensure that the requirements for obtaining informed consent are met.
• Demonstrate understanding of the information in the investigator's brochure, including potential risks and drug side effects. Forward a copy of the investigator's brochure to the IRB and Pharmacist and ensure that it is maintained on file with the site's regulatory documents.
• Ensure the accountability of NCI-supplied drugs.
• Maintain adequate and accurate records.

Note: See Section 9 of the FDA 1572 Form for complete information on investigator responsibilities. This form can be obtained from the CTEP Website, http://ctep.cancer.gov/forms/FDA_Form_1572_Final.pdf.

Clinical Research Associate or Research Nurse

A well-implemented protocol is often attributable to an organized, responsible CRA or Research Nurse. The PI may delegate some or all of the following tasks to the CRA or Research Nurse:

• Prepare regulatory documentation (IRB approval, IRB-approved informed consent, additional certifications defined in the protocol, etc.) needed for protocol-specific site registration for submission to the CTSU.
• Assure that the study is conducted in compliance with protocol requirements.
• Maintain IRB correspondence and regulatory documentation.
• Meet with the study patient to review the study enrollment details.
• Evaluate study patient for protocol eligibility.
• Assure that informed consent has been obtained from the patient before initiating research-related activities.
• Develop strategies to retain study participants in the clinical trial.
• Schedule tests and appointments for patients within time frames required by the protocol.
• Validate patient height and weight for accurate body surface area determination.
• Send the prescriptions for study medication to the Pharmacist.
• Complete Case Report Forms (CRFs) accurately, mail the originals to CTSU, and retain a copy in the CRF Notebook.
• Maintain source documentation for each study patient in accordance with CTSU guidelines.
• Recruit potentially eligible persons for clinical trials participation.
• Instruct and educate patient regarding study treatment modalities and anticipated side effects and their management.
• Provide guidance to the Principal Investigator, Pharmacist, and patient on dose adjustment based on protocol dose modification section.
• Inform the Pharmacist about any dose changes.
• Collect returned study medication and monitor patient dosing compliance.
• Identify abnormal laboratory results and obtain repeat evaluations as required by the protocol.
• Identify and document adverse events and serious adverse events.
• Initiates Serious Adverse Event Reports (SAEs) and obtain the PI's signature within the proper time frames, notify proper individuals stated in the protocol, and fax report to the CTSU.
• Respond to data queries from the CTSU in a timely manner.
• Contact the CTSU with questions regarding study implementation.

Note: The PI is responsible for the research conducted at the site, even if select tasks are delegated to the CRA, Research Nurse, or Pharmacist.

Pharmacist

The Pharmacist or designated qualified staff member is accountable for:

• Study drug supply, storage, preparation, dispensation, and disposal
• Records and ensures record security
• Retention of:
  • Shipping receipts and return records
  • NCI Drug Accountability Record Forms (DARFs)
  • Transfer forms
• Medication administration record
• Maintenance of blinded study integrity
• Instruction to the care provider on the proper method of drug administration

Note: The PI is responsible for the research conducted at the site, even if select tasks are delegated to the CRA, Research Nurse, or Pharmacist.

Patient Advocacy

Cancer patient advocates are devoted to supporting the common goal of facilitating cancer research. A patient advocate can be a cancer survivor just completing treatment, one several years out of treatment, a person living a lifetime with cancer as a chronic illness, or one who has been affected by the disease through a friend or family member. Advocates choose to get involved in cancer education and support. Involvement in activities related to patient advocacy is diverse and can include supporting outreach and educational activities about cancer clinical trials and helping to improve the lives of people with cancer. Patient advocates work with health care professionals, industry professionals, legislators, and other cancer patients and their families in many different areas, such as clinical trials development and education, policymaking, fund raising, support, and other areas. They also work to educate other patient advocates.

Patient advocates are becoming more prominent in the research arena. Advocates participate in research planning and review groups, including the National Cancer Institute's agenda-setting Progress Review groups and the American Cancer Society's grant application review committees. The Department of Defense has included advocates as voting members of review panels and the Food and Drug Administration has advocates on its advisory committee. In addition, NCI established the Director's Consumer Liaison Group, which advises and makes recommendations to the Director from the perspective of cancer consumer advocates. NCI has also developed the Consumer Advocates in Research and Related Activities (CARRA), a program designed to increase the involvement of advocates in NCI activities.

The CTSU hopes to work more closely with cancer patient advocacy groups. Patient advocates are invited to review patient education materials for CTSU protocols and to offer suggestions for improving the operations of the CTSU. Their suggestions for patient education materials have resulted in materials that better describe cancer treatment options and choices for clinical trial participation. Patient advocates assist sites implementing CTSU protocols by serving as liaisons between potential clinical trial participants and investigators. They can also help potential clinical trial participants make informed decisions by facilitating access to information about cancer clinical research trials.

It is important for patient advocates to understand the research process. Many patient advocates have taken the initiative to seek additional education. Orientation and training is an integral part of the CARRA program. Other organizations, such as the American Cancer Society, the Coalition of National Cancer Cooperative Groups, and others have developed training programs for their advocates. Because of the availability of training programs, there is a larger pool of knowledgeable advocates available for positions on research advisory boards, public policy committees, institutional review boards, and as publication reviewers.

To find out more about cancer patient advocacy, visit the Coalition's Patient Advocacy Website at http://cancertrialshelp.org. The CTSU Public Website at http://www.ctsu.org/links.asp offers a list of advocacy groups in the "Disease-Specific Resource Site" section. Another helpful website is http://cancer.gov.