How to design your next diagnostic study for successful execution and efficiency

When it comes to designing diagnostic clinical trials that are modernized, efficient, executable, and cost-effective, there is a strong need to think and plan beyond standard scientific design. Designing your next diagnostics study for successful execution means having the ability to put in place a customizable, all-in-one, yet flexible approach to designing a study that caters to the specific needs, challenges, and goals of the diagnostic study at hand. To do this, there is a much more holistic approach needed to building a diagnostic study. 

Operational executions 

A substantial portion of designing and planning for diagnostic clinical research is the focus on operational executions and the feasibility of all trial components. This means that diagnostic studies need to be designed in collaboration with the parties involved in the execution in order to set a study up for success. What does this include? 

Choosing a diagnostic site model

Choosing a flexible site model that is right for the specific diagnostic trial. Although Curebase clinical site models are typically categorized into five buckets, it is important that each site model is flexible and capable of adapting to specific trial concerns and needs. With this said, no two diagnostic trial models will look the same.

Some aspects to consider when choosing a site model may  include: 

• What type of diagnostic is being studied?
• Will it be self-administered by the patient?
• Is there a need for follow-up care or long-term patient monitoring?
• Are there any geographic barriers to overcome?
• Are there any trial components that are not necessary to be in person? – how many in-person elements are necessary? 
• Etc. 

Other aspects to consider are the settings and procedures necessary throughout the study (i.e. patient surveys, phlebotomy or sample collection, biopsy, etc.). Knowing the answers to these questions can be very helpful in understanding how the site model needs to perform. 

Recruitment 

Patient recruitment strategies, similar to site models, can be adaptive and dynamic based on the specific needs of a diagnostic trial. When designing a recruitment strategy it is important to understand the extent of recruitment capabilities and the exact ways in which diagnostic studies can practically recruit patients in a cost and time-effect manner. 

Site models can have a significant impact on the right recruitment strategy for a diagnostic study. It is ideal to map how patients will be recruited, how they will consent and enroll, and more. Knowing the desired patient workflow is a strong start to choosing which strategy is most effective in reaching the desired outcome. Having a diagnostic study vendor with the ability to adapt and handle time-sensitive recruitment parameters is key to ensuring patient recruitment for a diagnostic study is cost and time effective. 

The right diagnostic contract research organization (CRO) 

Understanding the CRO needs for a diagnostic study is the first step in choosing the right CRO.  Diagnostic CROs can look different amongst various studies and it is important to be able to identify the exact in-house capabilities of each CRO and how they can execute your trial design. The right diagnostic CRO has the tools, technology, and services needed to offer an all-in-one, yet customizable, approach to any diagnostic study. The key to finding the right diagnostic CRO lies in finding a vendor with the experience, know-how, built-in flexibility, technology-driven capabilities, and services that can specifically cater to individual study needs. 

Supporting sites 

It is important that when diagnostic studies are being designed, they are incorporating site feedback. One way to do this in a more streamlined manner is to work with an experienced DCT/CRO vendor that is data-driven and has the capacity to collect this feedback and make informed decisions based on previous experience. 

Sites and site staff need to be properly equipped with all necessary technology and virtual components by either ensuring sites already have these elements or distributing these tools when needed. Properly equipping sites also includes site staff education where necessary whether it be on protocols, technology, or software usage, etc., site staff need to feel comfortable in their roles and be able to assist patients to the best of their abilities. 

In order to utilize a flexible site model and be able to optimize site performance and streamline study flow, participating sites need to be properly supported and listened to. Vendors with experience in working with sites and site networks typically have the understanding and ability to cater more closely to site needs. 

When it comes to holistically designing and executing a diagnostic clinical trial, having resources such as vendors with collaborative CRO services, a fit-for-purpose technology platform, patient recruitment adaptivity, flexible site models, well-experienced and data-driven methods can be a crucial nominator in whether a trial is successful and efficient or not.