Clinical Protocol Development

Development of new, institutional Clinical protocols has an equivalent priority to peer-reviewed funded research. In many cases in the past clinical protocols have not carried their own funding. However, we strongly encourage investigators to at least include funding for statistical, data management and analysis support. The following steps should be followed to receive biostatistical input for a new institutional protocol:

At least one month before the deadline please e-mail cancer@bios.unc.edu to line up an initial meeting. A meeting will then be arranged, usually within one week of your e-mail. Please include a phone number, a pager number or an e-mail address along with an indication on what is the best way to get in touch with you.
Either e-mail in advance or bring to the initial meeting a short written summary of your planned study along with the specific aims. One of our statisticians will help you to actualize your specific aims, plan your sample size and identify the analyses needed. Sometimes this can be done during the meeting, but most work must be done by the statistician after this meeting. If you are attempting a more novel analysis, even more time may be required. Sometimes additional questions may arise following the meeting, which would require additional correspondence by e-mail or an additional meeting.
Once you have written a complete protocol in the form approved by the Protocol Review Committee (including the statistical analysis portion), send it back to your statistician for a final review. According to PRC guidelines, the statistician must sign off on the protocol before the PRC will review it. The statistician will usually respond within one week.

From the above, you will note that a typical protocol, with no unusual analyses or study design, may take 3 weeks plus the time it takes you to write a complete protocol. For investigators who have successfully worked with us already, and who are working on straightforward treatment trials, the time can often be expedited by having a complete protocol, (except for the statistical section) available at the time of the first meeting. The statistician will then write the statistical section and detail the needed changes to the rest of the protocol within one week of the meeting. If all the changes suggested by the statistician have been adopted, send back the revised draft of the protocol stating "Expedited Approval Requested". In that case, approval could be granted within 48 hours.

University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center, Biostatistics and Data Management