The cost of clinical trials is rising at a steady pace. With enterprises allocating narrower budgets, it is becoming extremely difficult for firms to get quality results. Preparing a budget for clinical trials is a crucial process since it would determine the cost of hiring professionals and renting equipment.
Research has shown that inducing flexibility in the clinical trial budget is necessary for making the trial successful. This is because preparing a 100% accurate budget is not realistic, and a lot of unforeseen costs can occur in the future.
Here are a few of the most prominent cost drivers for clinical trials that get considered before the finalization of the clinical trial budget:
The costs related to patient grants are generally broken down into screening, baseline and follow-up visits, and medical imaging costs. Screening involves several protocols to pick only those subjects that would be suitable for the trials. The screening would most probably take place at hired clinical sites under the supervision of a preclinical CRO.
Based on the type of research you are conducting, you might also have to reimburse the patients for their travel, food, and overnight stays. Medical imaging is not always necessary, but it is good practice to carry provisions for them.
Site costs refer to the costs that would get incurred to set up the sites where the initiation of the trials would begin. It involves the start-up fees, the Ethics Committee fees, and the storage fees to name a few. The start-up fees would be necessary to commence the clinical trial as the Ethics Committee (EC) submissions and the staff training costs would get included under it.
The Ethics Committee fees would have to be paid for the time spent by the Ethics Committee to look over the protocols of the clinical trial.
You can’t conduct a clinical trial alone. You would need to enlist the help of other professionals. Hence, you would have to set out a different part in your budget under the name of labor costs.
This involves hiring a Contract Research Organization who would be in charge of monitoring data from the trials, a biostatistician who would be responsible for drafting SAP (Statistical Analysis Plan), and a project manager who would look over the various facets of the trial, such as its timeline, budget, and resources.
Throughout the clinical research, there are going to be a ton of unforeseen and miscellaneous expenses. Carrying a provision for such types of expenditure is crucial because when they pile up on each other, they can significantly impact the financial stability of the research.
Miscellaneous expenditure can incur in the form of investigator meetings, document translations, and regulatory filing fees.
Any clinical research would meet several bumps on the way. These can be in the form of protocol amendments and trial enrollment delays. Protocol amendments become necessary when there is a change in the primary objectives of the research. Such amendments can lead to an increase in the cost of the trial since it would pave the way for IRB/EC fees, regulatory re-submissions, and site costs.
Moreover, sometimes delays can occur in enrolment because initial patient projections are overly optimistic. Taking provisions for such expenses in your budget can help you in the long run.
Trial budgeting is always a challenging process for management. By keeping these provisions in your budget, it would be ensured that your clinical research would get carried out seamlessly without any hassle. Apart from these provisions, you can also include the provisions for non-patient costs and site management.
Source: Topicstalk
By z zk 
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