Title: 'On-Demand' Computerised Decision Support in paediatric emergency drug administration
Funder: Department of Health and Social Care

Abstract: The project will be delivered across five (5) work packages some of which will work in parallel. WP1 - Product Build and Validation/QMS/Risk Management: Our technical team will undertake the necessary development work and software validation required to move towards certifiable subcomponents in preparation for the first clinical study. In collaboration with the BNF, we will perform a database gap analysis, including data still represented in free text format, and establish the Data Transformation Engine (DTE) specification, as well as the nature and extent of the gap in preparation and administration data. We will finalise the build of the DTE and demonstrate end-to-end functionality and cloud-updatability. In conjunction with the build components, we will commence the development of our ISO-compliant Quality Management System that will drive the input and output processes of our technical team. A key aspect of this will be the undertaking of the Risk Assessment from both technical and clinical perspective, ensuring the QMS development is risk-based. Risk mitigation strategies will be developed across the programme. We will develop a comprehensive training manual to ensure robust end user training is addressed. The Helix Centre will be the Manufacturer of the device, and Imperial College London will be the Sponsor of the clinical investigation. These roles are required under the Medical Device Directive/Regulations to report device related incidents to the MHRA and REC. We will ensure a safety plan is developed in line with applicable regulations. WP 2 - Research Strategy Development: The research team will work with our consulting Contract Research Organisation to generate the required documentation in the appropriate format for submission to the UK Competent Authority and Ethics/HRA. This work package will lead to the development of an ISO-compliant Clinical Investigation Plan (CIP) outlining the Primary and Secondary aims and objectives. The primary objective is to demonstrate safety and performance (delivery/usability) of the device. The secondary objectives will look at time to drug administration, reduction in medication errors, and healthcare professional user feedback. WP 3 - Regulatory Approvals: We will obtain the necessary approvals to conduct the first-in-man clinical investigation. Approvals will be sought from the Medicines and Healthcare products Regulatory Agency (MHRA), Health Research Authority (HRA), Research Ethics Committee (REC) and Local Capacity and Capability (R&D) prior to study commencement. WP 4 - Study Delivery: We will deliver on the training provisions as outlined in the training manual. We will also conduct a single centre, first-in-man clinical investigation in a paediatric emergency setting over a 6 month duration. Data cleaning and analysis will take place followed by preparation of the end of study report/publication. This single centre, safety and performance clinical investigation will be conducted in the Paediatric Accident & Emergency unit, Imperial College Healthcare NHS Trust. WP 5 - Commercial Exploitation: We will intensify our commercial endeavours, including ongoing Intellectual property protection and relevant filings with the support of specialist regulatory and legal support, and Imperial College s technology transfer team. We will move closer to CE-marking as a regulatory milestone and commercial barrier to entry. We will develop an outcomes-based pricing model with NHS partners, which we believe will prove attractive enough to both providers and follow-on funders to deliver a successful go-to-market. The investigational device addresses a significant patient safety flaw in the offerings of a number of very significant companies operating in the medication administration space, and we will develop a business model that lends itself to licensing and/or future acquisition.

Lay abstract: Medication errors are alarmingly common, and three times more common in children than in adults. Errors are yet more common in paediatric emergencies. Even though under-detection and under-reporting are the norm, an error is estimated to occur once in ten drug administrations in emergency units. In resuscitations, the error rate is even higher - up to a quarter of drug administrations in some studies are incorrect. In paediatric emergencies, clinicians must make a series of complex calculations to determine the correct doses, dilutions and rates of administration of medication, all of which are often conducted under extreme pressure. A large child weighs up to 30 times that of a new born baby. This variation adds a significant potential for large miscalculation errors that does not exist in adult medicine. This problem has been neglected by technological advances in healthcare, and most attempts to improve medication safety have focused on adults. The Helix Centre has prototyped a computerised decision support system to calculate the correct dose and drug preparation information for any child. Once provided with the patient s weight and age, the software determines the safe dosing parameters for any given drug and a suitable method of administration for that individual patient. A personalised syringe label is printed, on-demand, that graphically illustrates on the syringe the safe preparation and administration instructions for the medication. This is supported by on-screen instructions to guide clinicians through the process. We are also working with the British National Formulary on a live database to ensure the system has the most up-to-date, UK-specific medication information at any time. We are currently concluding successful simulated trials. This proposal seeks support for further technical development of the prototype, as well as for the first clinical investigation to be based in the paediatric emergency department at St Mary s Hospital.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING
Health categories: GENERIC HEALTH RELEVANCE