Of the various guidelines in the Horizon 2020 Clinical Trials proposal is the unit cost. Below, we have explained the subject of unit cost in clinical trials in great detail.

Why use Unit Cost?

In most sponsor-funded clinical trials, industrial or academic, the prevailing payment model for patient recruitment is a ‘per-patient’-based.  The structure of this ‘per-patient’ cost is derived from the clinical trial protocol, to enable competitive patient recruitment. The competitive patient recruitment is manifested by the price tag that each medical centre assigns to this ‘per-patient’ cost structure. This allows the Clinical Trial Sponsor and managers to decide where to recruit the patients from.

The Horizon 2020 “Unit Cost” is an instrument that mimics, to some extent, the ‘per-patient’ cost structure, to allow more flexibility in patient recruitment in projects funded by the Horizon 2020 programme. Beneficiaries that properly utilize the “Unit Cost” will benefit from easier project execution (there is no need to document actual costs, e.g. timesheet management), and as a result, a simpler and easier financial audit later on.

The Horizon 2020 “Unit Cost” complements the commonly-used traditional form of “Actual cost” that is widely implemented in the programme. In Horizon 2020 clinical trial projects, it is possible to combine “Actual costs” and “Unit costs” in the budget structure, subject to the guidelines presented in Commission Decision C(2016) 7553.

The ingredients of unit cost in clinical trials

According to the Horizon 2020 guidelines and regulations, the “Unit cost” is defined per patient, per medical centre, representing the sum of the costs of the various required items, defined and derived from the clinical trial protocol, in the following manner:

Unit cost = {A1} x {B1} + {A2} x {B2} + […] + {An} x {Bn}

While {Ax} is the item of reference and {Bx} is the cost of the item in each medical centre.

An item {Ax} can be any of the following items, per patient participating in the trial:

  • Estimated number of hours of Personnel (Medical Doctors, Other medical personnel and Technical personnel)
  • Consumables
  • Medical equipment (based on depreciation cost)
  • Other specific services

Any other cost category, including travel and subsistence costs of patients or study participants, should be considered and reimbursed as ‘Actual costs’ and not as ‘Unit costs’.

The cost of the item {Bx} is always the historical cost of the item, as recorded in the certified or auditable profit and loss accounts for year N-1 (the last closed financial year at the time of submission of the grant proposal) of each medical centre (site). For example, medical doctor hours cost or cost of consumables can vary among medical centres.

Indirect costs are implemented by applying a 25% flat-rate on the sum of all unit costs, as defined above, excluding the unit costs of ‘Other specific services’ and/or costs made by third parties that are not used on the premises of the beneficiary (e.g. specific lab tests sent to an external service provider).

Note: the description here is a general one. There are specific instructions which apply to specific scenarios, such as the involvement of linked third parties, which we do not address here.

What has changed in the recent “Unit Cost” update?

The changes in Commission Decision C(2016) 7553 have allowed more flexibility and clarity to the way Unit Costs are implemented in Clinical Trials. These changes have rectified previous conduct that was less flexible and generated unwanted hurdles. The main changes are:

  • The ability to combine different reimbursement methods (actual or unit costs) was enhanced.
    • All personnel, assigned to horizontal tasks (e.g. study monitoring or study coordination tasks), can be calculated as actual cost, unit cost or a combination of the two.
    • Personnel directly assigned to the clinical trial, should be calculated as either actual or unit costs, but not a combination of both.
    • In case of multiple clinical trials under a single project, it is possible to have different sets of cost calculations, per trial, for each beneficiary.
  • Unit Cost can now be corrected and modified during the project execution under certain conditions.
  • An update of the scope of the decision by mentioning the new Clinical Trial Regulation EU No 536/2014

Understanding unit cost in clinical trials is an important stage leading up to your Horizon 2020 clinical trial proposal. If you need further assistance, refer to our available service.

Categories: Horizon 2020