What Every Clinical Researcher Needs to Know
Feasibility review is a process to ensure that a proposed study has a greater probability of being successfully completed.
Feasibility is two fold. Any study, pharmaceutical- or investigator-initiated, needs a review to be sure the research site can afford to do the protocol, and has adequate resources (personnel and physical resources) to do so. Additionally, at site assessments or site initiation visits supported by sponsors, a feasibility checklist is often reviewed to ensure that the site will be successful.
Feasibility review applies to the actual clinical research protocol, which describes the patient population, accrual targets, trial timeline, study procedures, and involvement of human subjects. Additionally, feasibility includes the true cost of conducting the study. Feasibility for conducting a study that is not investigator-initiated is best completed with input from the entire research team. It must address all elements on the feasibility checklist form and be based on verifiable data.
For investigator-initiated studies, a biostatistical analysis is critical to be sure the study design includes an adequate number of subjects to answer the research question. The procedures described here apply to all interventional clinical trials submitted to the IRB.
Download a feasibility form. This form is for informational purposes and is not required by the university. It is a tool to help determine if you will be able to enroll all the required subjects, provide all the required human subjects protection possible, adequately cover the cost of the study and collect rigorous data.
Questions for the Research Team
The Principal Investigator (PI) is accountable for study oversight, and with his or her team should consider the following questions:
Does the team have adequate time to conduct the study?
- Understand the federal regulations associated with conducting research?
- Understand the IRB’s and institution’s requirements for conducting research?
- Understand the protocol requirements?
Access to Subjects
- Recruiting the required number of participants is crucial to your study’s success. Look closely at the study population to which you have access:
- Do you see subjects in your clinic that meet entry criteria?
- Are there subjects that can be identified in the hospital Electronic Health Record who meet the entry criteria?
- Do you have confidence that by marketing publically you will find enough subjects to participate?
Staff
- Are there adequate people on the research team with the proper skills?
- Does the team, including the investigators, have all the required training and/or certification in:
- Human Subjects Protection training – CITI course
- GCP – CITI
- IATA training for shipping
- HIPAA
- Do they understand the protocol?
- How much time will it take to recruit? Schedule visits? Maintain subjects? This is often the most costly part of a research study and should be looked at with the input of the entire team.
Facilities
- Are there adequate lab facilities? Are they CLIA/CAP certified when required? Is their equipment calibrated annually?
- Is there adequate space to see study subjects and store study records?
- Is there private space for the monitor to review study records?
- Do you need a pharmacist? What are the storage conditions for the study drug?
- Will specimens require special processing? What storage conditions? Are these both available?
Budget
- Does the study budget pay for all required research-related services? (refer to the CPAP process in the Budget Building section)
- If the study budget is short, and the study is still considered essential, will the department or division cover the shortfall?
Timeline
- Can the study be completed in the projected time?
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