Internal Data and Safety Monitoring

Penn State Hershey Cancer Institute places the highest priority on ensuring the safety of patients participating in clinical trials. The initial review of a new protocol lies with the Scientific Review Committee (SRC) in reviewing new trials to ensure each trial, regardless of sponsorship or support, contains adequate plans for data and safety monitoring. Our Cancer Institute Data and Safety Monitoring Board (DSMB) is responsible for monitoring all investigator-initiated trials (IITs) authored by Cancer Institute investigators, regardless of federal, institutional or industry support. This includes single site IITs, as well as multicenter IITs coordinated by Cancer Institute investigators with data management and site coordination by the principal investigator and Cancer Institute Clinical Trials Office (CTO), and includes all phases of clinical trials conducted in our Cancer Institute. Where appropriate, the use of an external/independent DSMB for a trial (e.g., high risk, multicenter) will be recommended.

Once a trial is determined as appropriate for monitoring by the internal DSMB, the DSMB has the responsibility for continuing review and monitoring of the study. Our Cancer Institute DSMB’s review and oversight are written in to the IRB-approved protocol for such trials. The DSMB provides oversight of study progress and safety by review of the following information:

  • Rates of accrual and accrual retention.
  • Frequency and severity of adverse events (AEs) and serious adverse events (SAEs).
  • Response rates, where appropriate.
  • New information related to the trial, i.e., published scientific reports or other developments that may affect subject safety or ethical concerns.
  • Any changes to the anticipated risk/benefit ratio of the study that would affect its continuation.
  • Protocol deviations and violations.
  • Matters that pertain to serious errors or potential misconduct by any of the investigators or research staff, i.e., breaches in confidentiality, research fraud.
  • Subject complaints.
  • Conflict of interest.

The timeline for review of trials by the DSMB is determined at the outset of the study with approval by the SRC. The frequency of DSMB review required for a protocol (i.e., 6 month, yearly) is recorded by the PRMS Administrator and tracked in order that the appropriate DSMB submission documentation is requested from the study team in advance of a scheduled DSMB meeting. The PI and clinical research coordinator (CRC) are provided forms for submission of required documentation to the DSMB.  Links to the relevant information requirements and templates appear below.