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IF your study is a UNC, Investigator Initiated study (IIT), you MUST use an UNC Lineberger Template.
Contact the PRC Coordinator for this.

UNC Investigator Initiated studies which are quantitative and qualify for PRC review require a statistical signoff from the statistician who will be the statistician of record for that study, and therefore responsible for the study. This is to ensure that the study has adequately addressed study design and other statistical issues and is ready for a rigorous review by a PRC statistician.

While quantitative protocols submitted to the PRC for review require a statistical signoff, that signoff need not come from a BIOS SR statistician. BIOS SR statisticians are uniquely qualified to assist LCCC members, since they have extensive experience in designing studies that meet the standards required to pass the rigor of PRC Review. However, if a BIOS SR statistician hasn’t been a collaborator in the design of the study, or will not be overseeing the analyses, and/or will not be a co-author on manuscripts from the study, then they should not take responsibility for, and signoff on, that study. The person who is be responsible for the design and analysis of a study should be the one to sign the statistical signoff. It is highly recommended that this person be a trained statistician, but it need not be a BIOS SR statistician.

Qualitative research involves the process of collecting, analyzing, and interpreting non-numerical data. A study gathering information using focus groups is an example of a study using qualitative research methods. Obviously, this is very different from the quantitative expertise that statisticians have and use. Qualitative studies require a signoff, but not a statistical (or quantitative) signoff. Please contact the PRC coordinator Stacy Maxwell for further clarification concerning a signoff for a qualitative study.

If your study received PRC review at time of initial review it MUST be submitted to the PRC at time of annual renewal (UNLESS the study is closed to accrual and there are no patients on active treatment/intervention). The PRC has been mandated by the NCI to review all cancer and cancer related studies for progress and performance, and to close studies to accrual which are not performing in accordance with their stated accrual goals (i.e., low accruing trials).
For purposes of PRC review, we consider any trial performing at 40% or less of their previously stated accrual goals to be “poor performing.” This includes performing at 40% or less of overall goal at the halfway point of stated accrual (e.g., a study aiming to accrue 10 patients in 4 years having only 4 or less patients in 2 years). In these cases, a justification for low accrual MUST be included with the renewal documentation (this can be completed via relevant section of the PRC Cover Sheet).
If there is a clear rationale for low accrual, and plans in place to assure accrual goals will be met (or to lower accrual goals to more realistically reflect accrual trends), you should complete the relevant sections of the PRC Renewal Cover Sheet renewal delineating this rationale and plans to assure stated accrual goals will be met. Information in the rationale should include:

  • Duration of time the study has been open to active accrual (i.e. some studies are approved and opened but may be put on hold for other reasons – staffing, sponsor delays, amendments, etc.)
  • If a trial is actively screening but patients are ineligible, please include the number of patients screened and reason for ineligibility
  • Plan for increasing accrual
  • If you elect to lower accrual goals to reflect current trends, and this is a UNC Investigator Initiated study, please ensure that the study statistics have been appropriately updated to reflect these changes, and submit a revised protocol and statistician signoff to reflect these changes.
  • If the duration of accrual will be extended as a result of lowering annual accrual goals (e.g., if lowering annual accrual from 10 to 1 means that the study will take 10 times as long to complete), you MUST provide a clear, scientific justification for why the study will remain scientifically meaningful. I.e., if the study will take longer than initially expected, is the topic to be studied still relevant? Consider that other methods, treatments, or devices may have been introduced which may make the study focus no longer pertinent, particularly if it is expected to complete at a later date. The PRC will consider these factors when determining whether or not to close a study due to poor performance.

Studies which are low accruing and provide sufficient rationale may be approved for continuance without issue, or receive a six month re-review. The object of a six month re-review decision is to allow for an additional period of accrual to determine if the changes/updates/rationale provided at time of renewal review has been successful in achieving the stated goals. If these goals are not met within that window, the PRC may elect to close a study to accrual at time of re-review.

Depending on the changes, you may be required to submit a modification to the PRC for review. An amendment will either receive an Expedited review, which is intended to take no longer than five business days, or it will be assigned to the next available PRC agenda and receive a Full Board review. Further details on what is required for PRC Amendment Review can be found on our website, here.