Assessing Protocol Feasibility

Scientific value and the feasibility of managing a study

Once a Confidential Disclosure Agreement (CDA) is executed, a sponsor will then send the final protocol to the site for review and determination on whether or not the site would like to move forward with the site selection process and participation. When investigators are approached to have their site participate in a new research study, it is important to assess the scientific value and feasibility of managing the study.

It is helpful to start by assessing the scientific integrity of the protocol: 

  1. Is the protocol written well?
  2. Does it have sound statistical analysis methods?
  3. Are the end points answering a scientific question of value?
  4. Is the protocol realistic and ethical to perform for the chosen patient population?
  5. Are there competing protocols currently open to accrual?
  6. Is there an opportunity for scientific publication and authorship?
  7. Will this lead to strengthened collaboration with the sponsor for future research studies of greater scientific value?

The ability to manage the study from an operational standpoint also needs to be assessed. It is helpful to assess the need for additional resources to execute the protocol related activities, overall complexity of the protocol, time commitment to serve as the PI for the trial, adequacy of patient population and ability to meet recruitment requirements, additional training necessary, additional need for space, availability of equipment, costs to conduct the study, funding resources available and any issues with research billing and insurance coverage.

Principal Investigators and/or Research Staff should not agree to participate in a study until a financial analysis has been completed to ensure all anticipated expenses will be covered by the projected budget.

Finance and Sponsored Projects should always be consulted during any grant submission/budget preparation. There are requirements that have to be met to ensure a comprehensive budget is generated, which the Finance and Sponsored Projects Office can be of assistance.

CCRM COM SOP # 4 Protocol Feasibility provides tools to aid in a thoughtful evaluation of the protocol.