UNC New Study Resources

Lineberger Biostatistics and Clinical Data Management Walk-In Clinic


Do you have a question (or questions) that you would like to ask a Lineberger statistician? Not sure if you need a little, or a lot, of statistical input on your project?

Talk with a Lineberger Biostatistics Core Statistician at one of our regularly scheduled Walk-In Clinics.

For new requests or questions concerning the Biostatistics (BIOS) Core, please email: LCCC_BIOS@med.unc.edu

If you are unsure how much, or how little, statistical or research design input you might need, a good first step would be to meet informally with a LCCC statistician at our Walk-In Clinic. These clinics are on Tuesdays and Thursdays from 12 to 1 pm. Talking with a statistician at one of these clinics can be a good starting point, and a good way to get introduced to the BIOS Core and our Core services that might be of interest to you.

The LCCC BIOS Core looks to match statisticians with researchers and their projects based on expertise, interest, and availability.

Oncology Protocol Review Committee - for new studies

The Protocol Review Committee (PRC) is a multidisciplinary standing Committee of the UNC Lineberger Comprehensive Cancer Center and the UNC Clinical Cancer Program; a joint entity of UNC Lineberger, UNC Hospitals and the UNC School of Medicine. Its charge is the peer review of local and national research protocols involving cancer patients, or those conducted by UNC investigators with a focus on cancer, PRIOR to submission of the protocol to the UNC Institutional Review Board (IRB).

The PRC’s primary function is to ensure the scientific quality and patient safety of proposed studies. The PRC also monitors study accrual and may recommend closure of under-performing trials (via annual renewal review).

Submit your UNC Health Registry Cancer Survivorship Cohort Letter of Support to PRC before your review!

New Studies, please visit: http://unclineberger.org/protocolreview/new-studies

Required Documents for PRC Review:

  1. PRC Submission Cover Sheet - Any study which recruits from the UNC Health Care Clinical Settings for cancer patients must have sign off from the relevant Disease Group Leader.
  2. Prioritization Checklist (CPO Managed studies only) - This form should be completed/scored by the POD Leader from the appropriate oncology group.
  3. Final Protocol
  4. Investigator's Brochure
  5. Biostatistician Sign-Off Sheet - Any UNC Investigator initiated study must have some form of statistical justification. This includes smaller studies, such as those that are sometimes referred to as ‘feasibility’ or ‘pilot’ studies. (see below). For new requests or questions concerning the Biostatistics (BIOS) Core, please email: LCCC_BIOS@med.unc.edu

Small Study Design

The following describe ‘feasibility’ and ‘pilot’ studies. It should be noted that many studies contain aspects of both: A ‘feasibility’ study is a small study that is often conducted just to see if some aspect of the proposed research is ‘doable’. For example, an investigator may want to see if a questionnaire can be completed by patients at a particular point in time during their treatment. The primary measure of success for this feasibility project would be the proportion of completed questionnaires. The measure of precision for this objective would be the width of the 95% confidence interval of this proportion.

A ‘pilot’ study is often a small study with a sample size (often no more than 5 to 15 subjects). A pilot study is often done as a precursor to a larger study. While data from a small study of this kind rarely produces results that are publishable, these studies may gather crucial information that will be used in power and sample size calculations for a larger study, and may also provide important insight into the study design. Regardless, a pilot study must still contain a clear primary objective and a description of what constitutes a successful completion of the study. A successful pilot study may gather important estimates about measures of interest and their statistical variability. Again, these numbers would be useful in future power and sample size calculations.

Often, a small study will contain components of both these studies. Sometimes these studies may be referred to as ‘exploratory’ studies. The main point to remember is that ALL studies, regardless of size, must have a definition of success that is clear and measurable, and must have some justification for the sample size and/or a measure of precision.

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Clinical Protocol Office

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Investigational Drug Services

LCCC Data and Safety Monitoring Plans

Common Terminology Criteria for Adverse Events v3.0 (CTCAE) Website