wetenschapsdag 2023 | 63 Sessie 2b: Classificaties: van Chaos naar Categorie x1 Auteurs J.R. Meijering, dr. R. Hoencamp, dr. J.H. Nederhoed, prof. dr. R.A. van Hulst, prof. dr. D.T. Ubbink Abstract titel Challenges regarding patient inclusion in International Clinical Research Background In the last decades technology has developed to an extend that makes international trials more accessible with limited resources. At the same time rules and regulations in clinical research and monitoring have become more prevalent to ensure research quality and patient safety. To assess the challenges and difficulties in international clinical trials, the study team of the DIONYSIUS-trial1, regarding the effect of hyperbaric oxygen treatment on patients with ischaemic diabetic foot ulcers, has kept track of the various issues encountered while performing a multinational multicentre randomized controlled trial. Methods Since the start of the internationalization process of the trial records were kept for various countries of objections, obstacles and delays in participating or initiating the DIONYSIUS trial, whether it was because of bureaucratic, financial or cultural reasons. Feasibility was also taken into account, with consideration for available personnel as well as technological and medical availability. Results Australia was unable to join the trial, due to lack of funds, despite multiple grant requests made by the Australian collaborators. The Republic of South Africa could not participate without external funds, which could not be provided. Italy did not have the personnel to handle the requests for local ethical permission or to provide sufficient follow-up. Curacao is still in the process of joining the trial, despite well over a year of intensive assistance form the research team in gaining permission to start including patients. Even in collaborators issues were found regarding data collection and patient screening and inclusion. Conclusion International multicentre trials are prone to encountering difficulties in its execution. It is important to consider the obstacles and the time required to overcome them. When setting up an international trial, consider the collaborators not just for enthusiasm in participation, but make sure that they have the means, time and personnel necessary.
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