DISCRIPTION

Clinical Trial Agreements (CTAs) govern the terms of research between the University and set the expectations and responsibilities of the parties.  Industry initiated clinical trials are executed for trials following a sponsor- or investigator-initiated protocol.

Generally CTAs are funded by pharmaceutical and medical device companies, and are an important part of the Food and Drug Administration (FDA) approval process.  The data from CTAs help to ensure the safety and efficacy of the drug or device being brought to market.

In order to properly fund a Clinical Trial from an Industry sponsor it is important to understand where the costs associated with the study come from.  Generally, three main sources account for the majority of expenses associated with a clinical trial:

            1. Faculty and Staff Time and Effort

            2. Administrative Fees

            3. Patient Medical Costs

Payment for each of these three contributing factors can be collected in a variety of ways depending on the department and sponsor’s needs and restrictions.  The most common types of payments that are generated under clinical trials are as follows:

Start-up payments (non-refundable)	Start-up payments are received from the sponsor upon execution of the contract, prior to enrolling research subjects.  Sometimes the sponsor will require that UTHealth invoice for start-ups and sometimes they will automatically release payment.  It is important to read your contract and know whether or not you will need to invoice for this payment.  UTHealth requires that all start-up payments be non-refundable, due to the fact that these payments are reimburse UTHealth for the time, effort, and resources utilized during the administrative review process of the study.
Per patient payments	Once a study is up and running, some sponsors will only pay for completed patient visits.  Just like the start-ups, some sponsors will pay automatically upon receiving completed CRFs and study data, while other will require UTHealth to invoice for each patient visit.  Per patient payments are intended to reimburse the University for the faculty and staff’s time and effort spent attending to the study responsibilities around that patient visit.  This payment also contains the necessary funds to pay the clinic and/or hospital for all of the medical services and procedures provided for research purposes.
Milestone based payments	Milestone based payments are another way that sponsors can pay for a study after it is up and running.  Under this type of payment structure, the sponsor will only pay UTHealth once it completes a certain amount of work.  This can be after enrolling specific number of eligible study subjects, time based milestones of active work on the project, or some other measure which conveys to the sponsor that the University has successfully completed a meaningful amount of the total project contemplated under the Clinical Trial Agreement.  Similar to the other payment types, Milestone based payments can be generated automatically from the sponsor or they can require an invoice.  These requirements are detailed in the contract.
Invoiceable payments	Invoiceable payments are those which are not guaranteed to be earned by the study site.  An example of this type of payment would be an elective X-Ray required by the sponsor should the patient experience and adverse reaction to the study drug, or an MRI that is required by the sponsor which would could fall within the standard of care, but was performed outside the authorized window for third party insurance to pay for the procedure.  Invoiceable payments are never automatically generated and must be required via an invoice from the study team.

PROCESS

During the budgeted development process the department administrators, the study staff and billing team(s) should all meet to discuss the protocol and procedures and services provided as part of the trial.  A template for budget development is available on the SPA website.

COVERAGE ANALYSIS

The first thing that should be done is to complete the coverage analysis.  The coverage analysis is an itemized list of every procedure called for in the protocol.  This includes both effort based and patient care based procedures.  The coverage analysis details which visit each procedure will done at and whether or not it will generate a bill in the clinic billing system.  If an item generates a bill, the study team must designate whether that charge will be standard of care (SOC) or research.  All SOC items will need to have a justification provided to detail how that conclusion was made.  Adequate justifications include peer reviewed journal articles, nationally published guidelines from professional medical organizations, or national coverage determinations from the Centers for Medicare and Medicaid.  The Coverage analysis process is initiated by the department submitting the protocol to the IRB. The CRF team reviews all studies submitted to the IRB and identifies all studies that require a coverage analysis. The CRF team creates an agreement record in START (AGT record) for each coverage analysis. The department is notified once the coverage analysis has been completed.

COST ANALYSIS

After the coverage analysis has been completed, it is now time to begin working on the Cost Analysis (also referred to as the internal budget) The Coverage Analysis/Internal Budget tool (CAIB tool) is utilized to conduct a cost analysis. The goal of the cost analysis is to determine how much it will cost to conduct the study. This includes salary expenses for time and effort allotted, startup expenses, patient care expenses and additional fees that may be incurred. The CAIB tool provides a methodic approach  for capturing these costs. (See “CAIB Tool Guidance Document “ for additional resources)

NEGOTIATING BUDGET WITH SPONSOR

After the cost analysis has been completed the departmental staff is now ready to negotiate the budget with sponsor. Please be sure to include additional amount to cover hidden costs such as underestimation of time and effort and or increase in costs.

DEPARTMENT TASKS/RESPONSIBILITIES

             1. Submit Protocol to IRB

             2. Submit draft CTA to SPA vis START (See START guidance document “ Clinical Trials-PD”

             3. Review final Coverage Analysis. if any issues are noted, submit change request to crf@uth.tmc.edu for approval

             4. Calculate the costs associated with Start Up, Per Patient procedures and effort based costs utilizing CAIB tool.

             5. Negotiate with sponsor to ensure that your final budget covers all costs associated with the study.

             6. Submit START Proposal Record to SPA

             7. Review final contract to ensure the budget is correct.

SPA TASKS/RESPONSIBILITIES

             1. Ensure a Coverage Analysis (CA) has been created for all applicable studies.

             2. Ensure an Agreement record (AGT) has been created for CA in START

             3. Work with the department to incorporate changes to CA if applicable

             4. Negotiate legal verbiage for all CTA’s submitted to SPA via START and execute agreement with Sponsor