Abstract

Background

Successful enrolment of patients to early phase clinical cancer trials (EPT) requires adherence to strict inclusion/exclusion criteria assessed during the trial screening period. Patients who consent but then do not meet these criteria are considered screen failed patients (SFP). A 2016 audit carried out at The Christie NHS Foundation Trust (The Christie) revealed a high (32%) screen failure rate in an EPT patient population, including an avoidable failure rate of 16%. Following this audit, practice changes were implemented to reduce avoidable failures. The aim of this re-audit was to re-evaluate the SFP using 2018 data.

Method

Patients were identified from a database of all patients consented to an EPT. Retrospective data was collected from 155 patients consented to EPT between 01/01/2018 - 31/12/2018. Reasons for screen failure were explored using EPT workbooks and patient’s electronic records and medical notes.

Results

Patients were consented to one of 35 EPT. SFPs constituted 23/155 (15%) patients. Median age of SFPs was 61yrs (42-72yrs), M: F 1:1.3. In the SFP population the most common cancer types were lung (11, 48%) and GU (4, 18%). Reasons for screen failure included abnormal baseline imaging in 5 (22%) patients, including 3 patients with a new diagnosis of brain metastasis. Abnormal blood tests, rapid disease progression and co-morbidities each occurred in 3 (13%) of SFPs. Unexpected death (disease-related), biopsy failures, cardiac issues and unexpected trial closure each occurred in 2 (9%) of SFPs. Decisions to screen fail were made by Principal Investigators in 18 (78%) cases and by sponsor in 5 (22%). Avoidable failures were present in 1 (4%) case. 

Conclusion

SFP rate decreased to 15% in the current audit, compared to 32% in 2016. This reduction demonstrates the positive impact of implementing practice changes. The audit will be repeated on a regular basis for quality assurance.