Assessing Feasibility & Establishing Start-Up Costs for Site Success
Developing a clinical trial budget for an independent or hospital-based research site can be an overwhelming task. The sheer amount of detail required to build an all-encompassing budget tends to require a unique skill set and careful meticulousness from the person in charge of negotiations on behalf of the site.
Why Does it Matter?
The first step to developing your budget should always start with a feasibility assessment, this is usually a quick process and is needed to ensure that your study is financially viable and that your site can cover the costs. This is especially important as to not waste the time and resources from multiple parties to analyze the study only to find out in the end that the study isn’t feasible.
How to Confirm Feasibility?
Upon trial award, here are the steps that you will need to take to determine if a study is feasible.
1. Conduct an overview of the completed protocol from the sponsor. This does not need to be a thorough deep dive, but you will want to make sure that the study is no more complex than how it originally appeared.
2. Make sure you have the patient population needed in order to support the study. This can be a huge factor to determine whether or not this study is worth taking on, and if you would actually be able to deliver the patients needed for the study.
3. Confirm whether or not you have the resources and study staff available in order to conduct the study. Before committing you’ll need to make sure that your site is capable of meeting the needs of the study.
4. Determine what departments are involved in the study. If your study has imaging, you want to make sure that you have feasibility to do radiology, whether an external group or internal department, etc.
5. Find out if the sponsor is willing to negotiate from the original offer to properly compensate your site’s required fees for start-up as well as other ancillary site fees.
6. Submit justification document of start-up and site fees to the sponsor. Most sponsors at the industry level are willing to negotiate these, federal studies can tend to be less flexible with this.
Establishing Start-Up Costs
For Study Staff
The next step after determining feasibility is to determine start-up costs, which can vary from site to site. The first thing you’ll want to do is identify the study staff that will be directly involved with your trial activities; this can include - Principal Investigator, Sub-Investigator(s), Study Coordinator(s)/Clinical Research Coordinator(s), Data Entry Personnel, Research Nurse(s), Infusion Suite Staff, Lab Staff, Investigational Pharmacist(s), Radiology Staff, and others.
Once you know who is going to be involved you will be able to sufficiently estimate the study’s efforts - which activities will be done by whom, how much time will be spent by each staff member on each protocol required start-up activity. To get a decent estimate on study start-up costs you will want to take the time spent (in hours) and multiply it by the staff’s hourly rate.
For Your Institution
To determine your institution’s start up costs you’ll want to identify any institutional areas involved in the start-up process of implementing a clinical trial. What are the costs for their time/review? This is not a one size fits all cost as every institution may have a different process. Some institutional start-up costs may include administrative groups, grants/financial management groups, regulatory efforts/prep, research site cleaning fees, billing/coverage analysis fees, legal counsel review fees, site training/materials compensation.
Additional Site Specific Costs/Hidden Fees
There can be additional site specific costs and fees that you may not have originally thought of but are important to capture in your administrative costs. These can include:
1. IRB Fees - For anybody who utilizes local IRBs there are usually initial fees, annual fees, amendment, termination, oversight, etc. Central IRBs are usually pass-through costs, this means that the sponsor will cover them. Do not neglect the time that it takes for your staff to actually do the paperwork to submit to that IRB as it is a substantial amount of time.
2. CTMS (Clinical Trial Management System) - A CTMS is beneficial to both the site and sponsor but can be extremely expensive so you can transfer some of those costs onto the sponsors.
3. Record Retention Fees - Most studies will have a contractual obligation to retain records for an X amount of years, so you now have to carry the burden of that cost. You will need to know what the cost is to actually archive it and ensure that the sponsor is actually paying you for that.
4. Monitoring Visits - This can take time from PI and study staff’s daily activities/patient care. Especially now that more sponsors and sites will be requiring remote monitoring visits due to COVID-19, you need to consider the additional time de-identifying source documents may require.
5. Audit Fees - (For Cause & Not For Cause) More often than not sponsors will strike for cause during the negotiations, but it is fair for the sponsor to cover not for cause audits, as they are not caused by the site and as extremely time burdens.
6. Close-out Fees - Important to make sure the sponsor compensates you for the various departments involved, the data clean and lock, and the regulatory and finance document reconciliation.
7. Other Annual Fees - Licensing fees, translation fees, regulatory maintenance, finance fees/revenue cycle management, administrative fees, monitoring fees, supply fees, departmental upkeep/storage/maintenance.
The information above only scrapes at the surface of items to think about when building site budget plans. Learn more about building a comprehensive budget that accurately captures site costs, negotiating tactics, and much more by tuning in to our on-demand webinar Budget Building & Negotiations: An Organized Approach for Successful Trials.