IF your study is a UNC, Investigator Initiated study (IIT), you MUST use an UNC Lineberger Template.
Any UNC Investigator Initiated study which qualifies for PRC review requires statistical input and signoff from an approved biostatistician. This is to ensure the quality of cancer research conducted at UNC, and additionally ensure that the study addressed the rigorous requirements of PRC statistical review.

Although any statistician can provide input for a trial, it is recommended that the UNC Linebeger Biostatistical Core be used to provide oversight and guidance regarding the development of a study design and statistical underpinnings. The UNC Lineberger Biostats Core is experienced in advising on a variety of studies, and can provide invaluable input on how best to address the requirements of PRC statistical review. The UNC Lineberger Biostatistics Core provides free “clinics” on a regular basis as well as a general contact email. At this time, it is recommended that new investigators seeking guidance email the general contact email to obtain advisement on how best to move forward. For further information, please see details on their website here.

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.