A multidisciplinary-guided digital solution to data capture in early-phase clinical trials.

Abstract

e18063 Background: Data capture in early phase cancer clinical trials (EPCCT) is usually via paper records with manual transcription to the sponsor’s case report form. Capturing real time trial data directly to computer (eSource) may reduce errors and increase completeness and timeliness of data entry. A simulated system pilot took place between Oct 2018 and Jan 2019 at an EPCCT facility to appraise Foundry Health’s eSource system “ClinSpark”. Aims were to assess consistency and effectiveness of creating electronic templates for source data capture and live data collection compliance. Methods: A multidisciplinary focus group (2 research nurses, 1 doctor, 3 data managers) was created to collaborate with Foundry Health staff. The focus group agreed on a 52 item user acceptance test listing ideal features for a data collection tool, classifying items as high, medium or low priority. Specialised features of the eSource system were adapted to handle the complex needs of EPCCT. The pilot incorporated a 5 day boot camp for familiarisation to the digital platform; a conference room test using simulated patient data; construction of a trial template including contingency planning; and a clinic floor test with live simulated patient data collection using digital tablets. Results: During the 3 month pilot, templates for 2 EPCCT were planned and created. Using eSource, 43 items (83%) of the acceptance test were passed compared with 27 items (52%) for the current (paper-based) system. The paper system did not pass any of the 9 items for which eSource failed. For the 30 high priority items, eSource passed 30 (100%) compared with 22 for the paper system (73%). Time saving and potential error reduction were noted as additional benefits. Conclusions: This process demonstrates that a multidisciplinary approach can be used to successfully integrate a customised eSource system working with previously untrained staff. Improved performance across pre-specified domains and potential additional benefits were noted. As FDA encourages the use of digital solutions in clinical trials, using eSource provides a potential solution for compliant and efficient capture of data from protocol assessments at investigator sites and rapid data transfer to sponsors.