Designing clinical trials for future space missions as a pathway to changing how clinical trials are conducted on Earth

Abstract

Objective:The project aims to build a framework for conducting clinical trials for long-term interplanetary missions to contribute to innovation in clinical trials on Earth, especially around patient involvement and ownership. Methods:We conducted two workshops in which participants were immersed in the speculative scenario of an interplanetary mission in which health problems emerged that required medical trials to resolve. The workshops used virtual reality and live simulation to mimic a zero-gravity environment and visual perception shifts and were followed by group discussion. Results:Some key aspects for the framework that emerged from the workshops included: (a) approaches to be inclusive in the management of the trial, (b) approaches to be inclusive in designing the research project (patient preference trials, n-of-1 trials, designing clinical trials to be part of a future prospective meta-analysis, etc), (c) balancing the research needs and the community needs (eg, allocation of the participants based on both research and community need), (d) ethics and partnerships (ethics and consent issues and how they relate to partnerships and relationships). Conclusion:In identifying some key areas that need to be incorporated in future planning of clinical trials for interplanetary missions, we also identified areas that are relevant to engaging patients in clinical trials on Earth. We will suggest using the same methodology to facilitate more in-depth discussions on specific aspects of clinical trials in aerospace medicine. The methodology can be more widely used in other areas to open new inclusive conversations around innovating research methodology. K E Y W O R D Sclinical trial methodology, clinical trial, evidence-based healthcare, medical simulation, research methodology, space mission

Choosing Wisely in clinical practice: Embracing critical thinking, striving for safer care

“…Plenty of resources are currently available to improve doctors' ability to use EBM correctly, starting from critically reading manuscripts, comparing them to previously available data, all the way down to designing new trials that could improve patient outcome and satisfaction [31][32][33]. Critically approaching EBM means not stopping at the first step, that is, "evidence synthesis," but rather continuing to the second one, which is "knowledge translation."…”

“…Plenty of resources are currently available to improve doctors' ability to use EBM correctly, starting from critically reading manuscripts, comparing them to previously available data, all the way down to designing new trials that could improve patient outcome and satisfaction [31–33]. Critically approaching EBM means not stopping at the first step, that is, “evidence synthesis,” but rather continuing to the second one, which is “knowledge translation.” The evidence must be translated into practice by medical practitioners who select treatment options for specific cases based on the best research, patient preferences, and individual patient characteristics [34].…”

Assessing the application of barbed sutures in comparison to conventional sutures for surgical applications: a global systematic review and meta-analysis of preclinical animal studies

“…In light of these considerations, we recommended compliance with SYRCLE’s standard to design animal experiments and to report all the information about experiments based on the report specification in ARRIVE 2019 84 . It is necessary to provide standardized animal models and consistent evaluation methods for future preclinical animal experiments aiming at diverse clinical needs 85 .…”

Rare diseases and space health: optimizing synergies from scientific questions to care

“…This participation highlights the high degree of skill among astronauts required to perform innovative life science experiments, among the dominating physical and material sciences experiments 34 . Despite their involvement in the execution of research experiments, astronauts are not always involved in the process of generating research questions and designing experimental protocol to better tailor the space health focus on both their needs and interests 35 . Increased astronaut involvement in research, mainly through greater stakeholder power in determining experiments (i.e., ensure research addresses what matters to the astronaut not only to the researcher) could increase the relevance and uptake of the research outcomes.…”

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