From 2005 to 2017, the number of studies registered on ClinicalTrials.gov has increased from 24,921 to 256,544 globally, making it no secret that Principal Investigators (PIs) and their staff have more to do than ever. Investigators are asked to take on trials, and oftentimes, seek out trials themselves. While each trial could potentially help advance science, it’s important for PIs to perform a protocol feasibility assessment each time, keeping the site and participants’ best interest in mind.
A protocol feasibility review helps research staff evaluate the possibility of conducting a trial. Once conducted, the assessment helps ensure to research staff – PIs, study teams, IRB, administration – are in agreement with the study’s blueprint. Protocol feasibilities are impacted at every point in a study, from design to submission.
Conducting a protocol feasibility analysis may seem time consuming at first, but when done right, it will save research staff time and money in the end. Below are things to keep in mind when executing a feasibility assessment.
Questions to Ask When Measuring Protocol Feasibility
About 80% of studies are delayed because of lack of staffing and/or participant recruitment. More often than not, when studies are lacking in these two areas, it will prolong the study itself, impacting the budget and logistics. A feasibility assessment helps account for these setbacks, ensuring appropriate budgeting and overall conduct of a study.
While performing a feasibility assessment, there are various questions to ask:
- Is the protocol written well?
- Is the protocol realistic and ethical to perform?
- Do the end points answer a scientific question of value?
- Is this going to lead to a stronger relationship with the sponsor for future research studies?
On top of asking these questions, it’s imperative for PIs to wait until a financial analysis is complete before agreeing to take on the study. This is to ensure the budget is approved and requested expenses are covered before moving forward.
Steps to Incorporate into Your Next Protocol
Once a PI is ready to move forward with a trial, there are steps for research staff to take to avoid potential time-consuming roadblocks in their trial. These steps will also promote a greater chance of a successful trial, avoiding the possibility of costly errors.
Collaboration has always been key to clinical research, and many protocols wouldn’t move through the phases without a team of researchers behind it. Not only is it important to collaborate with staff members, but it’s important for PIs to consult with other clinical staff or peers about the trial. This gives a more well-rounded perspective of the protocol, and helps the PI see points they might have overlooked otherwise.
PIs should also keep the feasibility assessment as simple as possible – the more complicated the document, there’s more room left for misunderstandings or questions about the protocol, ultimately delaying the start of the trial. On top of a keeping an assessment simple, it should be consistent, keeping all necessary documents for the study intact. Documents should be stored together, limiting the chance for complications as the trial goes on.
Tips to Ensure Success
Not only can a feasibility assessment seem time-consuming, it also appears daunting to many. With questions to ask and steps to incorporate, it can easily feel as if the added effort isn’t worth it or something’s getting lost in the shuffle. Performing a protocol feasibility assessment doesn’t have to be overwhelming, especially if there are established guidelines to help make it successful:
- Designate clear roles, responsibilities and timelines for staff members on the study
- Seek guidance from clinicians, especially ones a PI has previously worked with
- Gather as much data as possible, and review the quality of information received
- Be strict about the timeline
- Review (and review again) before submitting the assessment
Performing a protocol feasibility assessment doesn’t have to be complicated, and if done correctly, is designed to help research staff conduct their trial more efficiently. Learn more about protocol feasibility in our upcoming webinar, How Protocol Feasibility Assists in Promoting Compliance. Join us on Wednesday, November 13 at 12:00 pm Central.