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 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.
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.
Guest post by Safeer Khan, Lecturer at Department of Pharmaceutical Sciences, Government College University, Lahore, Pakistan Introduction In recent years, the cost of conducting clinical trials has risen dramatically. This increase has posed a significant challenge for pharmaceutical companies, researchers, and healthcare innovators. According to a study published in Nature Reviews in 2017, the median cost of conducting a study was $3.4 million for phase I trials, $8.6 million for phase II trials, and $21.
