B79: Using electronic patient records as an effective tool to screen and improve recruitment to a Phase 1 trial in non-small cell lung cancer
1Christie NHS Foundation Trust, Manchester, UK,2The University of Manchester, Manchester, UK
Recruitment to Phase 1 clinical trials in patients with lung cancer can be challenging. Identification of suitable patients is often opportunistic, or dependent upon referral from clinicians with knowledge of the trial criteria. The MEKRT trial, a single-centre, open-label phase I trial, combining a targeted agent (selumetinib) with radical thoracic radiotherapy had lower than expected recruitment rates. To increase trial recruitment to the expanded cohort part of the study, a research fellow used an electronic patient record (EPR) to prospectively identify suitable patients.
The clinical web portal is an in-house EPR capturing all aspects of the patient journey. Clinicians complete a clinical outcome form for every new patient, which includes individual characteristics and diagnostic information at presentation. This allowed a list of all new patients with non-small cell lung cancer to be generated and screened for suitability of our Phase 1 trial. Suitable patients were then invited to clinic to discuss and assess eligibility for trial inclusion. The study recruited patients to a dose escalation part (n=6) and an expanded cohort (n=15).
In the first 24 months, 9 patients were recruited to an expanded cohort using traditional recruitment techniques. Based on this accrual rate, completion of trial recruitment was not expected until September 2016. With the aid of the EPR, the 6 remaining patients were subsequently recruited over a 4 month period, recruitment completing in February 2015.
A significant increase in recruitment was generated by the identification of suitable patients using an EPR. This method of prospective, electronic data capture ensures all potentially suitable patients are identified, facilitating and increasing trial recruitment. We have now implemented this recruitment method routinely for lung radiotherapy trials in our institution.