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NCI National Clinical Trials Network (NCTN) Program Guidelines

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PART 1: Overview of the <strong>NCTN</strong> <strong>Program</strong> Section II – Goals of <strong>NCTN</strong> Research<br />

application for the <strong>NCTN</strong> <strong>Program</strong>. Although QOL studies may be conducted in conjunction with a clinical trial<br />

conducted by the <strong>NCTN</strong> <strong>Program</strong>, DCP reviews, approves, and funds such studies; they are not funded under the<br />

<strong>NCTN</strong> <strong>Program</strong>. Support for <strong>Network</strong> Group committee liaisons in these areas to coordinate with DCP and other<br />

organization supporting these types of studies can be funded under the <strong>NCTN</strong> <strong>Program</strong> to facilitate<br />

collaborations on <strong>NCTN</strong> trials.<br />

D. Collaborations Among <strong>Network</strong> Group and with Other Organizations on <strong>Clinical</strong> <strong>Trials</strong><br />

<strong>Network</strong> Groups are encouraged to collaborate with each other and with other <strong>NCI</strong>-funded programs and<br />

investigators (e.g., <strong>NCI</strong> Cancer Centers, Specialized <strong>Program</strong>s of Research Excellence [SPOREs], early clinical trials<br />

networks, other <strong>NCI</strong>-supported multi-site clinical trials networks, and R01 and P01 investigators). These<br />

collaborations may include advancing research ideas from pilot studies to phase 3 trials (with hand-offs between<br />

various <strong>NCI</strong>-funded programs where appropriate), providing correlative science services for large, multi-site<br />

studies, and participation in multi-site trials conducted throughout the <strong>NCI</strong>-supported clinical trials system.<br />

Collaborations with other <strong>Network</strong> Groups and <strong>NCI</strong>-supported programs and investigators are a distinct<br />

component of the peer review assessment of the <strong>Network</strong> Group.<br />

E. <strong>NCTN</strong> <strong>Clinical</strong> <strong>Trials</strong> Originating from Outside the <strong>Network</strong> Groups<br />

As part of the Terms and Conditions of Award, <strong>Network</strong> Groups are required to provide trial operations, data<br />

management and statistical support for multi-center phase 2 and 3 trials originating outside the <strong>Network</strong><br />

Groups provided that such trials are evaluated/prioritized by the <strong>NCI</strong> disease-specific Steering Committees and<br />

approved by <strong>NCI</strong>/DCTD for development utilizing the resources supplied by the <strong>NCTN</strong> <strong>Program</strong>. <strong>Network</strong><br />

Radiotherapy and Imaging Core Services Centers are also required to provide core services support for such<br />

trials as well as collaborations with other sponsored <strong>NCI</strong> clinical trials programs (e.g., early phase clinical trials<br />

networks) approved by <strong>NCI</strong>/DCTD under the <strong>NCTN</strong> <strong>Program</strong> but which are not evaluated by the <strong>NCI</strong> diseasespecific<br />

Steering Committees. This subset of trials that originates outside the <strong>Network</strong> Groups will require the<br />

same level of attention and commitment from a <strong>Network</strong> Group as does a study developed by a <strong>Network</strong> Group<br />

member. The <strong>Network</strong> Group is expected to integrate the investigator who conceived the trial proposal into the<br />

development and conduct of the trial.<br />

F. Conduct of <strong>NCTN</strong> <strong>Clinical</strong> Research<br />

Practitioners of clinical trials have an obligation to take appropriate steps to protect both the integrity of science<br />

and the human subjects who participate in research studies. Good <strong>Clinical</strong> Practice (GCP) is an international<br />

ethical and scientific quality standard for designing, conducting, recording, and reporting trials that involve the<br />

participation of human subjects. <strong>Network</strong> Groups as well as all other key components of the <strong>NCTN</strong> should strive<br />

to comply with this standard to the greatest degree possible since it provides public assurance that the rights,<br />

safety, and well-being of trial patients are protected, and that the clinical trial data are credible. Information on<br />

GCP standards in FDA-regulated <strong>Clinical</strong> <strong>Trials</strong> is provided at: http://www.fda.gov/oc/gcp/default.htm.<br />

The integrity of clinical data is a function of the entire process of data collection and analysis. <strong>Network</strong> Groups<br />

as well as the other key components of the <strong>NCTN</strong> need detailed Quality Control and Quality Assurance plans and<br />

systems to assure protocol adherence in the administration of protocol-prescribed therapy and in the uniform<br />

collection of data. Vigilance to detect honest errors, whether systematic or random, as well as data falsification,<br />

is especially important to clinical trials since independent replication of most trials is not feasible.<br />

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