Digitalized Protocol Eligibility Criteria enable both human readability but also immediate use in RWE tools in a digitalized form for machine readability.
Clinical Trials Digitalization
Clinical Trials Digitalization requires Clinical Development Organizations (CDOs) to digitalize as much as possible of their assets in order to fully benefit from digital transformation and process automation. One such asset in clinical study planning and design is the clinical protocol. By digitalizing the clinical protocol and leaning the study design process around it, CDOs can significantly improve their scientific throughput, reduce cost and time of development. Furthermore, with a digitalized protocol development process, most operational assumptions can be tested and verified before the clinical protocol is approved, significantly reducing the number of potential amendments.
One of the digitalized protocol elements that can be verified using the Real World Evidence (RWE) is the target population, i.e. IE criteria. However, the IE criteria is typically specified for human understanding in the unstructured textual format. Such format does not allow for easy RWE check of the assumptions made in the protocol, resulting in protocol amendments. If IE criteria is provided in a structured format, in addition to the textual representation, one would be able to verify all of the assumptions almost in real-time.
Where to start with digitalized Protocol Eligibility Criteria?
The inclusion and exclusion (IE) criteria in clinical studies are used to differentiate the treatments. With a very restrictive IE criteria we require smaller number of patients to be included in the study, which in turn decreases the time and cost of the study. However, that is a tricky balancing act, because if the IE criteria is too tight, you might not be able to find enough patients for the study. As a consequence, protocol amendments are necessary to loosen the restrictions, which can add approximately half a million dollars per study and amendment. Not to mention the delay in the research process and extra statistical considerations to be taken .
The IE criteria is usually written in prose which makes it easily understandable by people but not understandable by machines. However, in order to benefit from clinical trials digitalization, we need to be able to supply the IE criteria written in machine language so that we can verify all our patient population assumptions at the study design phase. Consequently, it is necessary for us to be able to bridge that gap and be able to represent the IE criteria in a more standardized form that enables these two faceted view of the IE criteria: for human understanding and for machine understanding.
Therefore, we propose structuring and standardizing the definition of the IE exclusion criteria in the clinical protocol, in such a way to enable both human readability but also immediate use in RWE tools in digitalized form for machine readability.
 Getz KA, Stergiopoulos S, Marlborough M, Whitehill J, Curran M, Kaitin KI. Quantifying the magnitude and cost of collecting extraneous protocol data. Am J Ther. 2015;22(2):117-124. https://doi.org/10.1097/MJT.0b013e31826fc4aa