When planning for a new clinical trial, the initial budget may be the first item that potential investors will look at. It is also likely to determine whether the trial is feasible or not.
There’s a lot at stake when preparing and adhering to a clinical trial budget – and it should be recognized that it is almost impossible to plan clinical study budgets with 100% accuracy. However, there are some efficient tactics to help minimize the potential budget increase that we will explore in this article.
To be able to adhere to your study budget, you first need to have a realistic budget estimate. Sometimes, there is pressure to adjust estimates to a “best-case scenario” - this can be particularly strong when circumstances force you to “sell” a study to investors or to compete for limited grant money. Alternatively, CROs competing over a potential study may provide budget for their services based on incomplete assumptions, leading to overly optimistic estimates.
Any misunderstanding of responsibilities may contribute to the gap between an initial estimate and reality, subsequently leading to the unexpected increase of the overall trial budget.
A good CRO will provide realistic estimates after clarifying the expectations, in the form of detailed, transparent and accurate budget grid. Several rounds of questions and answers are normally required for scope clarification, however, the detailed and accurate budget is well worth the effort.
Starting with assessing the potential countries and following through selecting the right sites, the feasibility study is often the most important prerequisite to a realistic budget. Often, the interests of marketing departments must be considered, making the task of site selection even more challenging, as high-profile sites are frequently not the best recruiting ones. As a result, countries and sites with high enrollment rates will need to compensate for potentially low enrollment at strategically important sites.
Different overhead costs that have a major impact on the study budget also need to be taken into account when following through with the country and site selection process, such as:
To keep the trial costs relatively low, it is recommended to engage only the number of sites necessary, spread across the minimum number of countries. However, the final list of countries and sites should be confirmed after review of high-quality feasibility data: sites are also competing for the trials and frequently tend to favor “optimistic recruitment scenarios”.
Therefore, a thorough reality assessment is critical to identify potential risks: any sites that you need to add later on will cause extra expenses and further delays. A high-quality feasibility report will include both data collected from the potential sites, and an independent expert evaluation, alongside subsequent recommendations for the best country and site setup to achieve planned targets.
Transparency and honesty in communication, starting from the RFP stage will make any future trial all the smoother. Having early access to the team of experts with industry knowledge as well as the local expertise will help you plan and navigate the trial. Considering and implementing recommendations provided by the CRO may also prevent unnecessary delays, having a direct impact on the budget. There is no clinical trial without issues but a good CRO will always openly communicate potential risks along with the proposed mitigation measures.
This is one of the terrains that Dokumeds is proud to have mastered: through our local knowhow, we can be upfront about what can be done in each country in which we operate – both from a legal and logistical perspective.
One of the most important lessons of last year is that even the best planned study is subject to unavoidable or unforeseeable accidents or disasters. When you are working with a multi-country, long-term project, the chance of this happening increases.
When something completely unpredictable (such as COVID-19) happens, some delays will be unavoidable. However, through honest communication and quick decisions, you can mitigate the effects of these delays. When dealing with abrupt closures, locked borders, or supply-chain disasters, a good relationship between CRO and client forms the basis of the most powerful rescue strategy.
An accurate budget will always be better than an attractive one. Your ability to get it right from the start will depend on your partners. By working with an experienced CRO that knows the region and therapeutic area, you will be able to land much closer to the final figure.