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.
- 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.