This is a question we frequently get in some form from Sponsors in early phases of development that are trying to figure out what it will cost to hire a CRO to conduct their clinical trials and associated regulatory activities. While the high degree in variability between trials would make it difficult to provide a single answer, we can explain what factors can drive costs up or down.
If you already have well defined information about your clinical trial, use this RFP specifications tool to request a more accurate and detailed estimate from Rho or another CRO.
Clinical Trial Cost Drivers
While there are many variables that can impact a clinical trial budget, these are some of the most common ones:
- Therapeutic Area: What therapeutic area or indication is the focus of the program? Some will be more expensive than others. For example, oncology studies are frequently highly complex and, in general, will be more costly than say an ophthalmology study with the same number of sites and subjects.
- Study Duration: How long will a study last? Short studies like a seasonal allergy study where enrollment happens quickly and the treatment period is relatively short would typically be a less expensive study than one that may require many months of treatment and follow-up.
- Number of Patients: How many patients are needed? The more patients needed, the higher the costs will be. Later phase studies where an accurate assessment of efficacy is needed tend to be more expensive than earlier phase studies where establishing safety is the primary objective.
- Number and Location of Sites: How many sites do you need and where will they be located? The more sites you need, the higher the cost will be. Geography is also important. In general, costs will increase for every additional country you add. Also keep in mind that conducting studies in some countries will be more expensive than in others.
- Number of Labs and Procedures: The number and complexity of labs and procedures will impact the costs. This includes direct costs from the CRO to monitor and manage the data as well as increased pass through costs from sites and central labs.
- Patient Population: Are you studying healthy or sick patient populations? What is the prevalence of the indication? This will impact your costs both in terms of safety considerations and speed of enrollment. How much competition is there? If you are working with a small patient population and multiple competing studies, this will likely drive up costs for patient recruitment as well as potentially increasing the enrollment duration.
- Clinical Monitoring Plan: How frequently do you anticipate needing monitoring visits? The total number of monitoring visits is a key cost driver and will be determined by the frequency of visits desired as well as the duration of enrollment and treatment.
- Safety Profile: What are the safety concerns with the treatment and patient population? The number and seriousness of adverse effects (AEs/SAEs) will impact costs, as will the need for a data safety monitoring board (DSMB) and any interim analyses needed to support it.
Looking for an answer tailored to your clinical study? Please contact us for cost estimates tailored to your program. We're also happy to set up an expert consultation if you need assistance figuring out how these cost drivers apply to your program.
Kara Roberts, Director Proposals and Contracts, contributed to this post.