By Ray Tobey, Chief Medical Officer on Feb 21, 2018 9:00:00 AM
This blog reviews key concepts in our new eBook, “How to Budget Sites for Clinical Trials”. Click here to download your free copy.
The breadth of experience and expertise at ClinSmart spans a wide range of areas including drug safety, regulatory services, IND preparation and also results driven budget planning. In fact, just recently we published a free eBook, entitled “How to Budget Sites for Clinical Trials”.
This content is targeted toward clinical trial sponsors and operations community to present why you need and how to set up a budgeting process for clinical sites. There are varying interpretations or descriptions of what is clinical site budgeting.
We define it as the process to allocate every activity of a trial into a singular cost per patient or cost per patient visit. This cost will determine how much to reimburse each site within your study. We hope you download and read the eBook in its entirety, but we also wanted to provide a preview and highlight some of what we discussed in our next two blogs posts.
The huge price tag associated with clinical trial costs
We all know that it’s expensive to get a drug on trial. But have you looked at the actual numbers? For instance, a study by PhRMA states that a study making it to FDA approval, on average, takes at least 10 years and $2.6 billion. This means that clinical trial operations, including the time taken to budget for a trial, breaks down to a cost of $710,000 per day.
Moreover, an analysis by PCRS Network that looked at data released by Sanofi and Abbvie, concluded that the opportunity cost of a drug NOT being on the market for one-day ranges from $2 million to $3 million. Altogether, this means that the operational cost plus the opportunity cost of one day of a clinical study can exceed $2.7 million. For this reason, we find it imperative to share our knowledge and expertise to help sponsors lower their clinical trial costs.
Process for lowering budget site costs
Unfortunately, there is no ‘one size fits all’ template for budget site cost measurement due to the complexity of the clinical research and since every clinical trial has its own set of nuances. The good news is that we have developed a proven, time saving, and cost cutting process to use for each individual clinical trial to determine your budget costs.
In brief, the process includes:
- Gathering large volumes of data about a trial and itemize the activities
- Creating a reusable budgeting framework
- Assigning costs to these items
- Developing a strategy to negotiate per-patient reimbursements to trial sites
We’ll dive into the specifics of the individual steps of the process in Part II of this blog series. However, here we wanted to emphasize that the rationale for each step is to save costs by saving you time and also helping in the negotiation process when considering pricing with your clinical trial site. One of the most effective way to save costs is to reduce the fee a clinical site will charge you, the sponsor.