About our Clinical Trials Office

Penn State Cancer Institute Clinical Trials Office is centralized to provide support for Cancer Institute clinical investigators in the development, implementation and completion of clinical trials.

We serve as a shared resource to provide assistance to clinical investigators in all aspects of clinical trial development, processing, coordination and management. The team is composed of clinical research coordinators, regulatory specialists, data management staff, a financial analyst, a database network administrator and a support associate.

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

Templates and Forms

Templates and forms for Penn State Cancer Institute Clinical Trials Office are available in CATS IRB (login required) by choosing Library, then Templates.

Contact Us

The Cancer Institute Clinical Trials Office is led by director Madeline O’Connor. For details, email PSCI-CTO@pennstatehealth.psu.edu.

Get Assistance with Your Protocol Development

Penn State Cancer Institute Clinical Trials Office personnel play a key role in assisting investigators with the development of new investigator-initiated trials. Their review and critique on draft versions of the protocol eliminates the need for modifications and amendments before or after the regulatory approval and/or study initiation and implementation.

CTO Responsibilities

• Providing guidelines and templates for clinical research studies at the outset of trial development, including working with relevant industry support to obtain an appropriate template, use of the PSHCI protocol template, or use of an appropriate template from NCI/CTEP’s guidelines.
• Ensuring that the protocol is written in a way that utilizes appropriate resources and simultaneously facilitates the involvement of appropriate personnel.
• Ensuring consistency throughout various sections of the protocol (protocol narrative, study calendar, dose modifications, etc.).
• Developing protocol tools and case report forms for data capture; working with the biostatistician to ensure the appropriate data capture to meet the endpoints of the trial.
• Preparing protocol summaries, consent forms and other necessary documentation for internal and external review (IRB, GCRC, FDA, NCI/CTEP).

All documents are discussed with and approved by the principal investigator. In some instances, meetings are facilitated by CTO staff to work through protocol revisions. Meeting attendance includes the principal investigator, co-investigators, fellows, biostatistician, clinical research coordinator, data manager and a regulatory specialist. Such a meeting provides an efficient way to collaborate on the protocol updates with action by the regulatory specialist after the meeting to ensure the prompt processing of the protocol through the review process. The master file on the protocol is maintained by CTO regulatory staff.

Templates and Forms

Templates and forms for protocol development are available in CATS IRB (login required) by choosing Library, then Templates.

Contact Us

For details, email PSCI-CTO@pennstatehealth.psu.edu.

How the Protocol Review Committee Works

The Protocol Review Committee reviews all cancer-related research throughout Penn State Cancer Institute and Penn State. This includes therapeutic trials as well as studies of behavioral medicine in oncology, cancer epidemiology and cancer control and prevention. There are checks and balances in place to ensure cancer-focused trials from all departments (such as surgery, dermatology, gastroenterology) pass through the Protocol Review Committee for review and approval before proceeding to the Institutional Review Board (IRB).

Penn State's IRB has jurisdiction for all biomedical and behavioral research throughout our Cancer Institute, Penn State College of Medicine and Penn State Health Milton S. Hershey Medical Center. It serves as a "gatekeeper" to assure that investigators of cancer research studies have appropriately passed through our Cancer Institute Protocol Review Committee before commencing the IRB approval process.  

The goal of the Protocol Review Committee is to ensure that research studies conducted by our Cancer Institute investigators are of scientific merit, high quality, reliable and verifiable. In an effort to support investigators in the opening of trials, CTO personnel are available to assist with the paperwork for Protocol Review Committee submission and the deliberations between the committee and investigators after review. Alternatively, the investigator can secure Protocol Review Committee approval independently and then present the trial to the CTO for further regulatory processing.

Protocol Review Parameters

To evaluate the scientific merit of a protocol submitted, the Protocol Review Committee considers the following criteria:

• Background data and scientific rationale to justify the proposed trial
• Study design
• Risk/benefit ratio
• Expected accrual rates/adequacy of patient population
• Adequacy of biostatistical design
• Existence of an adequate data safety monitoring plan
• Feasibility of completion within a reasonable time period
• Resource utilization
• Application format

Templates and Forms

Templates and forms for the Protocol Review Committee are available in CATS IRB (login required) by choosing Library, then Templates.

Contact Us

For details, email PSCI-CTO@pennstatehealth.psu.edu.

How we Monitor Data and Safety

Penn State 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 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, and includes all phases of clinical trials conducted in our Cancer Institute. Where appropriate, the use of an external/independent DSMB for a trial 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. Cancer Institute DSMB 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 and serious adverse events.
• Response rates, where appropriate.
• New information related to the trial, such as 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, such as breaches in confidentiality or 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 is recorded 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 are provided forms for submission of required documentation to the DSMB. 

Templates and Forms

Templates and forms for internal data and safety monitoring are available in CATS IRB (login required) by choosing Library, then Templates.

Contact Us

For details, email PSCI-CTO@pennstatehealth.psu.edu.