Information for Investigators
Penn State Hershey Cancer Institute Protocol Review and Monitoring System provides a mechanism for ensuring internal oversight of all Cancer Institute clinical trials involving cancer patients, including treatment trials, other intervention trials, behavioral studies, epidemiologic studies and cancer control/prevention trials. Our Monitoring System functions are largely carried out by the Scientific Review Committee (SRC) and include a review of the quality and scientific merit of trials, the prioritization of trials, and the monitoring of accrual progress on trials. The priorities for clinical trial development are established to enhance the scientific Programs at our Cancer Institute, with an emphasis on investigator-initiated trials and early phase peer-reviewed (NCI-CTEP sponsored) trials. However, the SRC requires that the disease teams conduct an initial review of all trials before they are submitted to the SRC. This initial review by the disease team serves several functions. Initially, the clinical trial’s principal investigator and the disease team review the trial for adequate patient resources, with careful assessment of other trials within the therapeutic area to make sure the new trial is a good fit for patient availability and that it measures up to the overall programmatic goals of the disease team. The disease team also reviews the protocol to identify and resolve practical operational issues in order to increase accrual rate. Once a new trial has passed through the disease team, the principal investigator submits it to the SRC for a comprehensive review of scientific merit and resource availability.
Creating a portfolio of trials of all categories is important, but members of the Cancer Institute are committed to the following priority scheme for categories of trials.
- Investigator-initiated trials (with all forms of sponsorship or support, including institutional)
- NCI/CTEP trials, cooperative group trials
- Industry-sponsored trials
- Penn State Hershey Cancer Institute Clinical Trials Office
- Protocol Development - Templates Included
- Scientific Review Committee - Submission Forms Included
- Internal Data and Safety Monitoring - Submission Forms Included