Meyerheim Marcel, Burns-Gebhart Anna, Mirzaie Kasra, Garani-Papadatos Tina, Braun Yvonne, Graf Norbert
Clinic of Pediatric Oncology and Hematology, Faculty of Medicine, Saarland University Hospital and Saarland University, Homburg, Germany.
Clinic for Pediatric Oncology and Hematology, Hannover Medical School, Hannover, Germany.
Front Digit Health. 2021 Sep 28;3:730680. doi: 10.3389/fdgth.2021.730680. eCollection 2021.
The increasing number of digital solutions developed for use in clinical health care settings is accompanied by new challenges to develop and conduct clinical studies that include eHealth technologies. Clinical study implementation plans often disregard or underestimate the necessity of additional administrative and logistic tasks required at clinical sites as well as ethical aspects to test digital solutions. Experiences made in the run-up of an observational clinical feasibility study at three international clinical sites in the framework of the MyPal project (https://mypal-project.eu/) result in recommendations to avoid delays and barriers in the planning of such prospective studies in clinical and also palliative care for increased efficiency.
为临床医疗环境开发的数字解决方案数量不断增加，同时也给开发和开展包含电子健康技术的临床研究带来了新挑战。临床研究实施计划往往忽视或低估了临床站点所需的额外行政和后勤任务的必要性，以及测试数字解决方案的伦理方面。在MyPal项目（https://mypal-project.eu/）框架下，在三个国际临床站点开展一项观察性临床可行性研究的前期经验，得出了一些建议，以避免在临床及姑息治疗这类前瞻性研究的规划中出现延误和障碍，从而提高效率。
