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Building clinical trial budgets from the schedule of events: white paper

Building clinical trial budgets from the schedule of events: white paper

Are you wondering how you can build a detailed clinical trial budget from the protocol, whether for a site, CRO, or sponsor?

This may appear an intimidating task. You have to read the protocol carefully, find the schedule of events, calculate how many times each activity occurs during the trial, and slowly create an itemised budget spreadsheet. There are cost items buried in footnotes that you need to look for.

The documents that you will need to review include

  • Study protocol
  • Informed Consent form
  • Clinical Trial Agreement, or contract (CRA)
  • Lab manuals
  • Charge Master or Fee Schedule
  • Any information about what costs are covered by the health system or Medicare or Medicaid
  • Sponsor budget

Upload your clinical trial protocol and create a budget with AI

Protocol to budget

Upload your clinical trial protocol in PDF form to the Clinical Trial Risk Tool and create an itemised per-patient and fixed costs budget using our charge masters, or upload your own charge master.

The Clinical Trial Risk Tool provides a solution. You can upload the protocol or synopsis and it will generate an itemised spreadsheet from the schedule of events, showing the fixed and per-subject costs in different sheets. It will even create separate sheets per site for multi-site trials.

You can find out more in our white paper.

References

  1. Pfeiffer, JoAnn and Windshciegl, Marilyn with guest author Garhan, Hailey, Managing Clinical Trial Budgets & Contracts, 2nd edition, LAD Custom Publishing, Inc. ISBN #: 9 780840 174000
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Clinical trial cost benchmarking

Clinical trial cost benchmarking

Estimating the total cost of a clinical trial before it runs is challenging. Public data on past trial costs can be hard to come by, as many companies guard this information carefully. Trials in high income countries and low and middle income countries have very different costs. Clinical trial costs are not normally distributed.[1] I took a dataset of just over 10,000 US-funded trials. You can see that the range is huge, from small device or behavioural trials costing as little as $50,000, while large multi-centre international trials can cost hundreds of millions.

Clinical study budget templates and generators - best practices to follow

Clinical study budget templates and generators - best practices to follow

Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction The success of clinical studies relies heavily on proper financial planning and budgeting. These processes directly impact key factors such as project timelines, resource allocation, and compliance with regulatory requirements. The accurate forecasting of costs for clinical trials, however, is a highly complex and resource-intensive process. A study by the Tufts Center for the Study of Drug Development found that the average cost of developing a new drug is approximately $2.

The anatomy of an oncology clinical trial protocol

The anatomy of an oncology clinical trial protocol

Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction Recent years have seen a substantial rise in oncology clinical trials, with annual growth exceeding 260 studies on average [1]. Despite this increase, these studies continue to be some of the most demanding and resource-intensive in clinical research. The combination of intensive monitoring, detailed assessment schedules, and highly specific eligibility criteria creates substantial operational challenges.