The Design Of Clinical Trials And Its Associated Support Systems In Interplanetary Missions – A Thought Experiment And Creative Workshop

Abstract

On Earth, the best available evidence to inform decisions on the effectiveness of treatments are randomised controlled trials. Depending on relevance of the question, availability of resources and willingness of individuals, these trials range from a few people to thousands. These trials are usually repeated across the world on different populations which provides further information on the generalisability of the effectiveness of interventions. Only a fraction of individuals on Earth participate in clinical trials to provide the evidence basis for the larger population. In aerospace medicine, the number of astronauts is quite limited so doing large clinical trials is difficult: the evidence in aerospace medicine primarily relies on simulated studies on Earth which may be randomised controlled trials or small case series with astronauts in space.

The current discussions on long term missions to Mars and other planetary exploration, raise the question of what is the ideal approach for building an infrastructure to conduct clinical trials for long term interplanetary missions. Long term missions require the continuous commitment and motivation of participants in the clinical trial, therefore patient involvement in the research process is more important. This paper uses a combination of a thought experiment with a creative, simulated and interdisciplinary workshop to build a conceptual framework on how clinical trial research infrastructure can be innovated in an inter-planetary mission. Some key aspects of the framework includes: a) Designing and prioritising interventions to manage the problem (democratic versus management approach) b) Overall design of the research project (applicability of prospective meta-analysis, patient preference trials, N-of-1 trials) c) Allocating participants to groups (stratification not only based on characteristics but also by roles and job specification, using Bayesian randomisation to allocate individuals into groups and patient preferred trials) d) Outcome selection and data collection (identifying biomedical, clinical, patient-related, performance-related outcome, data collection over time and monitoring need for adaptation and change) e) Ethics and Partnerships (ethics and consent issues and how they relate to partnerships and relationships). We will suggest using the same methodology to facilitate more in-depth discussions on certain aspects of a clinical trial or managing a diverse range of health problems e.g. contagions.