Principle 4 outlines the scientific, ethical and efficiency benefits of ensuring that a trial is fit-for-purpose, accounts for and utilizes the inherent characteristics of the trial's setting.
Ensuring that a trial is set up to be practicable and produce reliable, actionable results is an important scientific and ethical duty. Consideration of the context and existing resources in a proposed trial setting can better inform effective trial design.
Key Message: The design and implementation of RCTs should recognize and be shaped by the characteristics of the settings in which they take place. These include the health needs and preferences of communities, their ability to access healthcare, and their understanding of clinical trials, as identified through appropriate involvement, consultation and engagement with patients and the public.
Why this is important: These characteristics, alongside the nature and complexity of the research, are critical in identifying the ethical issues at stake and the issues, burdens and benefits of running the RCT in that setting. Relevant and accessible RCTs are more likely to recruit a sufficient number of trial participants. Good patient and public involvement and education across the relevant communities help shape successful recruitment and subsequent adoption of the results.
Key Message: RCTs should be tailored to be practicable given the available infrastructure in relevant settings. This includes making optimal use of pre-existing resources and facilities, including utilizing any expertise, skills, professional standards and quality oversight mechanisms associated with routine healthcare practice. While all individuals involved in performing a RCT should be qualified by education, training or experience to perform their respective task(s), it should be recognized that there are many aspects of delivering a clinical trial that are in line with routine care and therefore may not require additional training, procedures or checks.
Why this is important: RCTs should not be wasteful of staff and participants’ time, use of interventional or other medical supplies, energy, or environmental resources. Where there are strengths and safeguards in routine systems, these should not be duplicated or altered without careful justification. The closer trial processes are to routine practice for participants and staff, the more efficiently and effectively they are likely to be delivered and the fewer mistakes they are likely to make, resulting in improved quality.