Clinical trials are performed to demonstrate the safety and efficacy of a new drug, improve the capabilities of a known drug, establish superiority among similar drugs, etc. Clinical trial costs are increasing and so is the complexity of managing it.
According to the U.S. Department of Health and Human Services (HHS), Clinical Trial procedure costs are the highest in the first three phases of clinical study. Administrative costs are the highest in the phase 4 studies. In most cases, companies face challenges in the initiation phases which are highly complex for planning and forecasting.
Budget management must ideally address two key objectives:
- Allocation of sufficient amount throughout the Study from Startup to close out
- Recognizing what needs to be billed as Research related and what comes under the Insurance or Standard of care
Due to the increase in industry-sponsored trials, clinical sites are on the verge of cutting costs. Thus, budget management is critical for clinical trials planning and execution. Here’s a deep dive into Clinical Trial Budget Management.