Associate Principal Investigators and the HEAL-COVID trial: good for trainees, good for trials

• Published in: Current controlled trials in cardiovascular medicine 2024-01, Vol.25 (1), p.90-90, Article 90
• Main Authors: Newman, Joseph, Wild, Philip, Summers, Charlotte, Toshner, Mark
• Format: Article
• Language: English
• Subjects: Associate Principal Investigators; Career development planning; Careers; Clinical medicine; Clinical trials; COVID-19; Hospitals; Humans; Medical research personnel; Methods; Patient recruitment; Patients; Professional development; Training; United Kingdom; Variables
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-024-07936-x

The NIHR's Associate Principal Investigator (API) Scheme in the United Kingdom was expanded nationally in 2020 with the aim of training clinicians to become Principal Investigators for clinical research in the future. The HEAL-COVID adaptive platform trial is an urgent public health study registered with the API Scheme. Within eighteen months of opening, the trial had recruited almost 1200 patients with over 100 active sites. Here we describe our experiences of APIs working on the trial with two broad objectives. Firstly, we aim to explore through qualitative methods the impact that the scheme has had on the APIs' professional development. Secondly, we aim to quantify the impact that the APIs have had on the recruitment of patients into the trial. The professional backgrounds of the APIs are described from data from their application forms to the scheme. The HEAL-COVID API Network is described from records of the monthly meetings. The APIs' experiences are reviewed from data from the NIHR exit surveys at 6 months and from a reflective practice exercise at the final network meeting. Data of patient recruitment to HEAL-COVID was analysed for centres with and without APIs via a multivariate analysis. Forty-two APIs were registered with the HEAL-COVID trial with a diversity of backgrounds in terms of gender, country, profession, grade and specialty. Eleven monthly network meetings took place with the dual objectives of facilitating trial activity and providing educational content. Fourteen APIs completed the NIHR survey with all reporting Good Clinical Practice completion, local promotional activity of the trial, patient recruitment and support from their respective PI. Sites with at least one API recruited over 3.5 times more patients than sites without an API (medians 4 vs 14.5, p