In a recent webinar, Advarra experts Wendy Tate and Cheryl Byers provided considerations for building an effective feasibility process, including valuable metrics and information to use in a feasibility assessment. This is the second part of a two-part Q&A series, diving into questions that we did not have the time to answer during our live Q&A period.
Q: Are there industry-wide standards for things such as number of trials per Clinical Research Coordinator (CRC) or trial activities such as reconsent?
A: Due to varying complexity of trials, differences in therapeutic areas, as well as the diversity of tasks that a CRC performs, we are not aware of any industry-wide standards or benchmark measures.
Q: Do you know of a tool for us to input numbers and calculate a breakdown of how many subjects the site would need to enroll to break even?
A: I do not know of such a tool. This would require multiple inputs: staff salary, staff time per duty, cost of each procedure or resource in the study, and reimbursement rates of each procedure/resource/staff item. Also, due to extended study durations, amendments, and other unforeseen issues (such as recruitment rate, screen failures), this complicates the estimation of breaking even.
Q: Have you received pushback when trying to renegotiate a poorly budgeted study for time and effort? What are some tactics you would recommend for attempting this?
A: Yes! I think this is a common issue across sites. It is important to know how much time it takes to complete the research protocol. Often, the sponsor will give coordinator reimbursement for a subject visit, but we all know there is much more staff time required to execute a clinical trial. Knowing the time needed to do each item, itemizing it, and justifying it to the sponsor is the best way to negotiate (or re-negotiate) a clinical trial. The sponsor wants the trial to run compliantly, efficiently, and ethically so they can get complete and accurate data. Let them know that by reimbursing for all staff time at the full amount necessary, you can dedicate those resources to ensure those study objectives are complete. They are essentially “renting out” those staff resources dedicated to working that study.
Q: Is there a pricing guideline you can share that could indicate what amount a site should request for the informed consent form ICF, coordinator time, etc., to make it feasible for the site?
A: Unfortunately no. Pricing should be based on the salary (including benefits/F&A), overhead, and time to complete tasks for a specific study. It is important to know how much that task/procedure will cost your organization and negotiate for that cost.
Q: Related to investigator-initiated trials (IITs), approved grant budgets often do not include budgeting for study coordinator or regulatory staff. From a funding agency perspective, how is it possible to fund a study without appropriate budget for study staff?
A: There are numerous reasons why there may not be enough funds to support staff salary for an IIT. It could be because the investigator underestimated the FTE necessary to complete the protocol. Or, the funding agency stated they do not compensate for this work. This is a difficult area to navigate and is a spot where it is important to have your institution provide funds to help formally support these types of trials.
Having a “bucket” or “pool” of money to help support necessary grant work can supplement the lack of FTE coverage that a grant, foundation, or national group study provides. This highlights the essential nature of a feasibility review committee/process for IITs. This group can view the available budget and assess whether the remaining funds are appropriate to come out of the pool. It also gives an opportunity for administration to meet with the investigator to discuss the gap in funding and where the monies can come from to fill the gap. Does the investigator have left over funds from other studies to allocate? Can they utilize a different, less expensive resource? Are all the procedures necessary?
Q: Is it reasonable to demand from sponsors to provide as much information as possible up front towards feasibility? Things such as: budgets, full protocol info, onboarding requirements, training, etc.
A: If a sponsor wants a realistic expectation of your ability to complete a study, then the site should have all the documentation necessary to complete such a study. It is a fine balance – it can take time to go through all that information, which prolongs the feasibility process and activation timelines. However, if the site cannot assess their ability to complete the protocol or can’t address the items that the sponsor wants, then any information provided to the sponsor is uninformative and negates the feasibility process. It is not uncommon to need the draft budget, full study schema, recruitment expectations, staff training requirements, and investigational product requirements to complete feasibility requests.
Q: Our site has recently determined to close out any study that has not enrolled within 180 days. Could that be determined in a feasibility study?
A: Yes! Consider looking at recent, similar studies to assess how the enrollment curves progressed. Similar studies may come from the Principal Investigator (PI), disease and research team, or they may have a similar indication, phase, or intervention. Key metrics such as the time from open to accrual to first participant in, percentage of enrollment goal met, time to enrollment completion, and screen fail rate are used to assess likely accrual within the first 180 days.
Additionally, set the expectation with your investigators. Since they are opening a study because they have patients available, let them know the study will close after 180 days at open accrual status. When the final steps of a study are about finish prior to activation (like the subject initiation visit (SIV)), ask how many subjects were identified for being approached when the study opens.
It’s helpful to create a standard operating procedure (SOP) or policy to ensure transparency and consistent management. Create a communication/notification to the PI 90 or 120 days into a trial with no enrollment to assess the likelihood of success. This also triggers the PI to act and close a study if they do not anticipate enrollment due to an unforeseen circumstance.
To learn more about evaluating a site for feasibility, watch the on-demand webinar Clinical Trial Feasibility: Ensuring Success for Clinical Sites.