1. Key Question WHY USE A NON-TRADITIONAL RCT DESIGN?
Scientific (validity and contamination)
Practical (recruitment, consent, feasibility in implementation, costs)
Ethical (beneficence)
Contextual understanding
Nature of health or disease condition being studied (public/population health, emergency)
Nature of treatment (likely effectiveness, range of therapeutic options, duration in evaluating study endpoints)
Resource
Preference of stakeholders (e.g. community acceptability)
Behaviour of participants (e.g. sharing of medicine and contamination)

2. Key ISSUES And challenges
Methodological (scientific rigour, applicability of the concept of clinical equipoise)
Distinguishing research and implementation study
Defining the participants (implications for consent and post-trial provision obligations)
Informed consent (reasons for waiver, complexity of information)
Standard of care
Justice (e.g. equity in delayed participation and its relationship with equipoise )
Political interference (e.g. choice of first cluster v randomisation in SWCRT)

3. ThinKing…
To what extent should traditional ethical values in research ethics such as respect for persons be maintained in trials with novel alternative designs?
How do we effectively communicate the characteristics (e.g. evolving risk-benefit balance) and advantages of these trial designs to stakeholders such as IRBs, gatekeepers, participants etc in a given LMIC setting?