A pragmatic multicentre factorial randomised controlled trial testing measures to reduce surgical site infection in low and middle income countries (LMICs).
Countries: Ghana, India, Mexico, Nigeria, Rwanda, South Africa, United Kingdom. (Additional countries expected to participate in 2019)
The University of Birmingham is acting as sponsor for the trial, with co-ordination of the trial delegated to the Birmingham Clinical Trials Unit (BCTU). The BCTU acts as the International Coordinating Centre for the trial, with each collaborating country adopting a Hub and Spoke model, whereby the Hub is delegated defined sponsor oversight responsibilities.
Funding is from the NIHR Global Health Research Unit on Global Surgery, collaboration between the Universities of Birmingham, Warwick and Edinburgh. This included funding to support infrastructure development in each of the Hub countries.
The University of Birmingham is contracting with each participating Hub. Each Hub is then responsible to contract with their in-country spoke hospitals.
The University of Birmingham has put in place insurance for legal liability for claims for injury arising from the Trial and where the University of Birmingham was at fault e.g. due to an error in the protocol. International sites are responsible for ensuring appropriate insurance or indemnity for clinical negligence is in place in their respective country and in relation to their clinical activities related to the trial.
Participating international sites were contractually required to obtain required local approvals as per local regulations. Evidence of local approvals are collected by the BCTU, prior to the site being confirmed as open to recruitment. International sites were responsible for local safety reporting as per local regulations.
One single protocol was used for both UK and international sites, with country-specific requirements included as necessary. This included the lower age range for participants, clarification of consenting procedures and who can take consent, local safety reporting requirements.
Although central monitoring processes are being utilised, on-site monitoring will also be conducted. The BCTU will perform on-site monitoring of the Hub and the Hubs will perform on site monitoring of their Spoke hospitals.
The BCTU was responsible for sourcing one of the interventions (skin prep) and, via the company which manufactures the product, are organising the shipment to Hub sites. The sutures to be used in the trial are purchased in-country by the Hubs, using the grant funding.
No CRFs will be sent to the BCTU. Hubs will be responsible for data management within their country. The data will be entered onto the FALCON trial database by either data management staff at the Hub or by the site staff at the spoke hospitals. All original copies of the CRFs will be kept at the Hub sites. The BCTU will send any data queries raised by central monitoring to the Hub sites for resolution.
The FALCON trial does not include any sample collection.
Quality of life questionnaires are not used within FALCON. Health resource usage CRFs were created and are being used in a selected, small number of collaborating hospitals. The health economic analysis will be performed on a representative sample of the collaborating LMIC countries.
The trial data will be owned by the University of Birmingham as host institution. The main trial publication will be published in the name of the “FALCON Collaborative Group”. All collaborators will be listed as contributors. Individual countries will be allowed to publish their efficacy results.
Obstacles encountered
The main obstacles to date have been:
1. Obtaining appropriate in-country insurance, as some of our collaborating countries do not have such insurance as standard.
2. Navigating the local and national regulatory requirements and the decision of whether the trial is a CTIMP or not.
3. Agreement of contracts between Hubs and the sponsor and between Hubs and Spoke hospitals.