This post originally appeared on Fast Data Science’s blog on LinkedIn.
Budgeting for clinical trials is crucial to ensure all study aspects are covered and adequately funded. The process involves detailed planning, considering the scope of the work, and addressing specific trial needs, such as personnel, procedures, and participant-related costs.
Personnel Costs:
Study Procedures:
Protocol-Related Fees:
Travel, Meetings, and Miscellaneous Costs:
Overall Budget: The Principal Investigator (PI) manages the entire budget for multi-site or single-site trials.
Site Budget: When the local PI negotiates the site-specific budget, including patient enrollment and closeout costs.
Define the Clinical Question:
Determine Per-Subject Costs:
Identify Ancillary Department Costs:
Estimate Personnel Costs:
Include Protocol-Related Fees:
Account for Hidden Costs:
Minimize Data Collection: Collect only necessary data points to reduce costs.
Don’t Underestimate Recruitment Time: Failing to recruit patients on schedule can increase costs as infrastructure expenses grow.
Pay for Specific Tasks: Instead of budgeting for full-time equivalents (FTE), pay for time spent on tasks.
Needs to be more accurate in the number of patients or the time required to complete the study.
Overlooking hidden costs, such as adverse events or additional patient monitoring.
Forgetting to budget for specific storage, audit, and protocol amendment fees.
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Creating a clinical trial budget involves careful planning, considering all possible costs, and aligning the budget with the trial’s scope. By focusing on essential tasks, minimizing unnecessary procedures, and allowing flexibility for unexpected costs, you can create a comprehensive and effective budget to keep your clinical trial on track.
References:
NIH Clinical Trial Budgeting https://www.nihstrokenet.org/
Guest post by Youssef Soliman, medical student at Assiut University and biostatistician In today’s complex research environment, managing the finances of a clinical trial is as crucial as managing the science. Dedicated clinical trial financial management software solutions have emerged to oversee the monetary aspects of studies, helping maintain tight budgetary control and regulatory compliance. These platforms typically encompass capabilities like budget creation, real-time expense tracking, automated payments to sites and vendors, and the generation of audit-ready financial reports.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan* Introduction Pilot studies are a cornerstone of modern clinical research. These preliminary trials allow researchers to assess the feasibility of their hypotheses, refine methodologies, and identify potential obstacles before embarking on larger, more expensive trials with significant ethical implications. A well-structured pilot study not only saves time and resources but also reduces the chances of costly failures during later phases of the clinical trial process.
A number of documents are needed to produce a complete and accurate clinical trial budget. The necessary documents typically include: the study protocol (generally the most important document for building a budget) the informed consent form the clinical trial agreement or sponsor contract any laboratory and pharmacy manuals the charge master or schedule of fees the sponsor’s budget. However, sometimes a sponsor will send only the synopsis to a CRO when requesting a quote.
