Moving away from the boilerplate: Real-world evidence for clinical trial laboratory criteria.

Abstract

e14581 Background: There is a need to enable as many suitable patients onto clinical trials in oncology, that are also representative of patients seen in clinical practice. Currently, oncology trials often require patients to have minimum laboratory tests for hematology and liver function amongst others. We compared the real-world laboratory results and clinical information in TransMed’s patient repository against the requirements of a set of clinical trials to assess patient eligibility retrospectively. Methods: Industry-sponsored clinical trials for follicular lymphoma which started in 2018 were retrieved from the U.S. National Library of Medicine’s clinical trials website. We aimed to find the most common set of diagnosis inclusion criteria and the range of platelet requirements to those observed from real-world data. TransMed’s patient data was collected from its consortium of 205 clinical sites, which includes a variety of source systems at each site, such as electronic medical record systems and laboratory information management systems among others. Results: There were 16 trials which matched our criteria. The most common trial inclusion criteria were for grades 1-3a, progression after at least one line of therapy, and a platelet count > 75 x10-9/L. We found 53 retrospectively-eligible patients who would have met the trial’s main criteria when the patient was between therapies in 2018. At some point within 90 days before starting another therapy, 9% (5/53) of patients failed the requirement for platelet count. Among those, 40% (2/5) were within a 10% drop in the required threshold. Conclusions: We have presented an exemplar combination of cancer diagnosis with a single laboratory test and found patients who could be considered for trials though are deemed ineligible due to a narrowly-missed requirement. Many such tests vary over time, by cancer type, prior treatment, comorbidities and should be considered in the context of other test results. By using real-world evidence at the time of trial design, clinical trials can be optimized to allow improved patient recruitment and expanded availability to patients while ensuring clinical suitability.