Re-audit on screen failures in early phase cancer clinical trials; a single institution experience


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Sreeja Aruketty1,Joanna Clarke2,Daniel Lovelle Gomez2,Dilshad Chang2,Alison White2,Matthew Krebs2,Louise Carter2,Donna Graham2,Shaun Villa2,Fiona Thistlethwaite2,Amanda Rees2,Natalie Cook2
1Experimental Cancer Medicine Team, The Christie NHS Trust,2Experimental Cancer Medicine Team, The Christie NHS Foundation Trust

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.