Clinical trials need funding and an important role of the investigator is to cost the trial realistically and to secure financial support. We believe that trials should not be prohibitively expensive. Much can be done to ensure that trial conduct is sensible and pragmatic thus limiting expense and ensuring that valuable research is conducted. This is one of the central aims of this programme: to help make trials more pragmatic and to encourage researchers to embark on good trials that answer important questions to help improve health outcomes.

Here we aim to guide investigators in what they need to think through and how to approach setting and managing their budgets. It might be a tedious and frustrating element but is nonetheless important as it is not ethical to embark on a trial that has not got adequate financial support in place. A shortfall in funding could place the trial at risk of closing before all the data is collected and render the contributions of the participants meaningless.

As soon as an investigator begins to set the question, planning the budget and seeking the funding can begin. The sources of funding are varied but the approach to funding the studies remains standard. These sources include:

Fellowships - examples:

Project grants - examples:

Product development sponsors / Investigator initiated trials

Public-private partnerships - examples:

Most research sites have a finance department and they should be able to provide guidance on how to prepare a budget. The funder may also have strict guidelines regarding what can and cannot be included in the study budget (e.g. the NIH will not allow for purchase of vehicles) so it is important to familiarise yourself with all of the terms and conditions of funding before committing any funds.

Both the fixed and variable costs of the trial should be taken into account, as well as any applicable overheads required by the institution. Fixed costs can include the salaries of full-time staff required to support the study (e.g. data mangers, study coordinators, etc.), any equipment required specifically for the trial, any applicable ethics review fees, printing of CRFs and cost of study drugs. The variable costs are usually broken down as the cost per trial participant and include the amount payable for staff time at participating research sites: co-investigators, study nurses and pharmacists. Variable costs also include the costs of laboratory and other diagnostic tests, hospital bed time, and patient transport.

It is best to use the fixed-variable cost model for multi-site trials as this allows an accurate estimate of expenses at the coordinating centre as well as at participating study sites. By breaking down the costs per participant it is easy to estimate the costs for sites with varying recruitment targets. If a study is going to be conducted at a single site it may not be necessary to break down the variable costs.

You can download helpful tools and templates, including budgeting tools and budgeting monitoring tools, at this link and in the list below: 

 

Budget Monitoring tool

Budget Monitoring tool with example data

Budget Tool - Cost by Category

Budget Tool - Cost by Patient

This article originally appears on the Global Health Trials resources. Please visit us for more resources relating to trials.

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