Abstract
BACKGROUND: Clinical trial funders aim for trials conducted with high quality, within the planned time and budget. The majority of non-commercial investigator-initiated clinical trials do not complete participant recruitment in time or are discontinued early. In addition, the implementation of the results may be challenging. We aim to list the good practices available for public funders of clinical trials in Europe. Our focus is on practice-oriented trials exploring research questions not studied by industry. METHODS: We list the funding practices at the public trial funder KCE Trials in Belgium, together with good practices identified at the National Institute of Health and Care Research (NIHR) in England and ZonMw in The Netherlands. The literature on practices of public trial funders was searched. RESULTS: Assessment of the effectiveness of individual clinical trial funding practices is an under-studied area of research. Many funding practices have been integrated for decades in the NIHR HTA program, resulting in trials with significant health impact. Some practices of the commercial sector are now also used by public trial funders, such as on-site feasibility checks for recruitment capacity and paying sites based on participant recruitment and retention. The array of public funder practices with the collective aim to reduce risk and enhance impact can be grouped into ten categories: integration of the funder in the research user landscape; the funder's team and transparency in the use of public money; support for the sponsor's team; the terms and conditions of the funding, access rights and data sharing; an efficient and pragmatic trial design; trial selection and improvement; budget and payments, the importance of feasibility checks and site payments; recruitment and retention; dissemination and implementation of results; collaboration between funders and multi-national clinical trials in the EU. CONCLUSIONS: Public funders of practice-oriented clinical trials have tools available to improve the health impact of the trials they fund. The relative contribution of each practice in a funding program in relation to its cost remains to be studied. Challenges remain for recruitment in non-commercial trials and efficient funding and management of multi-national non-commercial trials.