What is a Clinical Study Budgeting?
Clinical study budgeting is a critical aspect of planning and executing a successful clinical trial. At its core, it involves estimating the financial resources necessary to achieve the trial’s objectives. These budgets are comprehensive, encompassing not only the overall trial but also breaking down costs by each study year, often tied to specific study tasks and patient recruitment. Despite the existence of best practices, developing a clinical trial budget is a complex process, influenced by numerous considerations and factors.
One of the fundamental principles of clinical study budgeting is ensuring flexibility. The budget needs to be adaptable to unforeseen changes and challenges that may arise during the course of the trial. It is important to note that sponsors are not obligated to cover expenses that fall outside the budgetary constraints, for that reason careful consideration of all potential costs is needed to avoid any financial gaps.
In delving deeper into the aspects of Clinical Study Budgeting, it becomes evident that this process demands meticulous planning and attention to detail. The budgetary considerations outlined in a presentation by the NIH, in collaboration with the University of Cincinnati and the Medical University of South Carolina, shed light on the nuanced concepts involved in ensuring the financial viability of clinical trials. Keep reading.
Major Cost Buckets in Clinical Study Budgeting
- People who do trial work
- Technology
- Study‐related care, including study intervention
- Statistical Analysis and Data Management Support
- Travel and Meetings
- Advertisement costs: Expenses related to promoting the clinical trial.
- Screen failures: Costs associated with subjects who do not meet the eligibility criteria during the screening process.
- Prorated payment for subjects who terminate, drop out, or are lost to follow-up: Financial considerations for subjects who do not complete the study.
- Startup costs: Upfront, nonrefundable payments to cover initial work, such as regulatory document preparation, investigator meetings, site initiation training, and enrolment efforts.
- Payment for close-down costs: Relevant in cases of early termination by the sponsor, encompassing the expenses associated with concluding the trial.
There are Two Types of Clinical Study Budgeting: Overall and Site
Clinical study budgeting comes in two distinct types, each with its own set of responsibilities and considerations. The first is the overall budget, where the Principal Investigator (PI) holds the reins for a multicentre or single-centre trial. This role encompasses a comprehensive oversight of all budgetary components, requiring a major focus on financial aspects related to the entire study.
On the other hand, the site budget presents a different perspective, involving the local site PI in negotiations with industry or other funding sources. In this scenario, the emphasis is on defining compensation for various stages of the trial, including start-up, per-patient enrolment, and study close-out. The site PI takes a more localized approach, addressing the specific financial aspects related to their site’s involvement in the clinical trial.
How to Prepare a Clinical Study Budget
Preparing a clinical study budget is a multifaceted process that involves addressing several critical questions. As highlighted in the NIH presentation, these questions serve as foundational elements to guide the budgeting process:
- Clinical Question and Study Duration: Define the clinical question and determine the duration of the study.
- Patient and Site Requirements: Establish the number of patients and sites required for the study.
- Measurement Types: Specify the types of measurements that will be employed.
- Per-Patient Costs: Identify and evaluate the per-patient costs associated with the study.
- Personnel and Technology Costs: Determine the personnel required, their compensation, and the costs associated with technology.
Clinical trial budgets are typically categorized into four primary parts, each crucial to the study’s success: protocol design and development, data capture and storage, analysis, and data dissemination. Protocol design involves a range of activities from consulting subject matter experts to personnel training, while data capture and storage encompass various elements like security protocols and database preparation. Analysis costs include the salary of the analyst and methods used, and data dissemination involves the costs associated with presentations, publication, and data sharing.
The NIH Stroke Net presentation provides valuable tips for effective budget preparation, emphasizing the importance of developing the budget early, seeking advice from experienced investigators and coordinators, and collaborating with coordination and data management centres. Additionally, having a good understanding of the study’s scale, using technology judiciously, and erring on the side of overestimation rather than underestimation are key considerations in ensuring a robust and realistic clinical study budget.
ECLEVAR provides comprehensive budgeting for your clinical studies
ECLEVAR is a Contract Research Organization with more than 20 years of experience in completing clinical trials for manufacturers around the world. Our team of experts is ready to assist your study from start to finish, using their extensive knowledge for make better use of your resources and deliver complete results. Contact us to know more about our services and how our solutions can help your Clinical Study Budgeting.