Clinical Research Operations

POLICY TITLE: Use of Standard Care Protocol

POLICY STATEMENT:
The Center for Cancer Research’s (CCR) intramural clinical program is focused on identifying new diagnostic, preventive and treatment approaches for cancer and HIV by translating discoveries from the laboratory and by applying new technologies. This is accomplished by enrolling patients with these diseases on innovative clinical trials. Delivery of standard care to patients outside of a research setting is not part of the mission of the CCR’s intramural clinical research program and consumes clinical resources that would better be utilized to support clinical research studies. However, under exceptional circumstances (listed below), patients can be treated with standard care therapies on Standard Care protocols, including:

• patients who have previously been treated on a CCR clinical trial and who are not currently eligible (but may in the future be eligible) for another clinical trial;
• patients who are seen by CCR consult services and who require treatment, such as patients from other NIH ICs;
• patients who are enrolled on other non-treatment studies that require longitudinal data collection and who require treatment;
• patients who were referred to CCR for a clinical trial and were found to be ineligible but whose condition requires emergency treatment that would preclude immediate referral back to their private physician (these patients should be referred back home once they are clinically stable to safely travel).

Exceptions to these criteria must be approved by the Branch Chief and the CCR Clinical Director on a case by case basis prior to initiating the consent process with the patient.

The number of patients enrolled on standard care protocols and the impact of delivering standard care on clinical resources (e.g., nursing, inpatient beds, pharmacy) will be monitored by the Office of the Clinical Director whose responsibility is to ensure that the resources are primarily utilized for clinical research rather than standard care.

Patients should not receive standard care treatment on a screening protocol.

The specific treatment regimen for the patient on the Standard Care protocol should be documented in the patient’s medical record to allow for nursing and pharmacy safety checks. Specifically, the treatment regimen (e.g., dose, schedule, duration of treatment, route of administration, surgical or radiation plan), expected toxicities and dose modifications should be described.

Branches may be held responsible for the costs of drugs used to treat patients with standard care therapies by the Clinical Center pharmacy.

Unacceptable Uses of the Standard Care Protocol:

Standard Care protocols will not be used:

• to recruit patients for training programs. Separate training protocols should be developed, and the scientific review of training protocols should consider whether the value to the training program justifies the use of clinical resources in the NIH Clinical Center.

• to treat patients who may be eligible for clinical trials in the future but who have not previously been treated on a CCR clinical trial.

• for research activities, such as performing pilot studies of new treatment approaches or collecting data on patients (except for demographic data), that consume research resources (e.g., research nursing, data management, databases).

• to treat patients with investigational agents.

SCOPE:  All CCR participants

CONSIDERATIONS/REFERENCES/DEFINITIONS:
The NIH policy on ordering chemotherapy should be followed when entering orders for treatment on a standard care protocol.
Non-research protocols:

• Screening protocols are designed to assess a subject’s eligibility for a research protocol by performing clinical, laboratory, radiographic and other tests required by the eligibility criteria of the research protocol. Screening protocols may also allow for collection of tissues for research purposes. Patients should not receive treatment on a screening protocol.
• Standard Care protocols are used to treat patients with standard of care therapies in a non-research setting. Patients on standard care protocols are not considered to be research subjects and no data are collected on these patients (except for basic demographic data). This policy addresses the use of standard care protocols.
• Follow-up protocols are designed to provide long-term follow-up of patients previously enrolled on a research study and to continue to collect follow-up data for the prior study. Patients should not receive treatment on a follow-up protocol.
• Training protocols are used to bring patients with specific diagnoses to the NIH for standard of care treatment with the justification that these patient populations are critical to a clinical training program. Patients on training protocols are not considered to be research subjects and no data are collected on these patients (except for basic demographic data).
• Natural History protocols are longitudinal research studies on which clinical, laboratory, radiographic and other data are collected with the goal of learning about the pathogenesis and course of specific disease states. Patients may receive standard of care treatment on a natural history protocol, but there are no research objectives on the protocol that address treatment.

REGULATIONS/GUIDELINES:  NA

RESPONSIBILITY: All clinical investigators will be responsible for implementing the policy according to the standard. The Branch Chief is responsible for approving/disapproving exceptions to the criteria for participating in standard care protocol. The CCR Clinical Director is responsible for approving/disapproving exceptions to the criteria for participating in standard care protocol and is responsible for monitoring the impact on clinical resources.