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Paediatric clinical trials need paediatric clinical trial budgets
Stavros Koulizakos1, Tina Kjellén1, Karin Mellgren2
1Pediatric Clinical Research Center, Queen Silvia Children's Hospital, Sahlgrenska University Hospital, Gothenburg, Sweden.
Insights
Pharmaceutical industry budgets for pediatric clinical trials often underestimate costs by 60%. Thorough budget review and negotiation are crucial for equitable cost distribution and trial continuation.
Area of Science:
- Pediatric Clinical Research
- Health Economics
- Pharmaceutical Industry
Background:
- New treatments and clinical trials are vital for child health.
- Budgeting for pediatric clinical trials presents unique challenges.
- Accurate financial planning is essential for successful trial execution.
Purpose of the Study:
- To analyze budget discrepancies in industry-sponsored pediatric clinical trials.
- To identify key areas contributing to budget differences between initial proposals and final agreements.
- To provide insights into effective budget preparation strategies for pediatric trials.
Main Methods:
- Retrospective analysis of 10 industry-sponsored pediatric clinical trials.
- Comparison of sponsor's initial budget proposals with final negotiated budgets.
- Identification of specific cost categories driving budget variations.
Main Results:
- The final budget was, on average, 60% higher than the initial sponsor budget (range: 31%-139%).
- Trial preparation costs, study activity time, and examination expenses were primary drivers of budget increases.
- Initial budgets frequently failed to cover substantial trial-related expenses.
Conclusions:
- Initial budgets from sponsors often do not cover the full costs of pediatric clinical trials.
- Comprehensive budget review, negotiation, and dedicated personnel are critical.
- Ensuring equitable cost responsibility is essential to prevent trial discontinuation.
Aim:
Clinical trials and the need for new treatments were recently listed among the most important factors for child health. The aim of the present study was to describe some of our experiences with budget preparations in paediatric clinical trials.
Methods:
We selected 10 trials sponsored by the pharmaceutical industry at the Pediatric Clinical Research Center at Sahlgrenska University Hospital in Gothenburg, Sweden. We compared the sponsor's initial budget (budget proposal from the sponsor), with the final budget (negotiated and agreed between sponsor and site) and identified areas where discrepancies may arise.
Results:
The mean difference in total budget amount between the initial budget and the final budget was +60% (mean 59%, range 31%-139%). The costs for preparation of the clinical trial, time spent for study activities and costs for examinations were identified as key budget items for these differences.
Conclusion:
Our findings indicate that a substantial part of the trial-related costs would not be covered by the sponsor, had the initial budget been accepted. A thorough review and budget negotiation, as well as to have a dedicated team member for this task, are essential to ensure equitable responsibility for the study-related costs and to avoid discontinuation of trials.
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