Clinical trials aim to draw conclusions about the effects of treatments, but many different questions could be investigated. For example, does the treatment work for only those patients who can tolerate the treatment and take as prescribed?, or does the treatment work for all patients even if not all treatment is received (e.g. not all doses of drug received)? Since different questions can lead to very different conclusions on treatment benefit, when planning a trial it is important to have a clear understanding of precisely what treatment effect the trial aims to investigate – this is what we call the ‘estimand’. The estimand captures for what patient population and under what conditions we seek to estimate a particular treatment effect. Using estimands helps to ensure trials are designed and analysed to answer the questions of interest to different stakeholders, including patients.

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We are conducting research to explore public partners’ perspectives on the importance of discussing estimands when designing a trial. Public partners are patients or members of the public that are part of the research team. This research project has resulted in the development of a practical tool for public partners that helps explain what an estimand is and what impact it may have in trial results. This has been developed with the HEALTHY STATS public involvement group (includes 5 public partners aged between 20 and 70 years of different ethnicities and sex).

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The two-page tool is available for researchers working in clinical trials to use as a first step in facilitating involvement of public partners in estimand discussions. The tool now needs to be assessed in different contexts, and we are interested in collecting feedback on using the tool in practice. 

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If you are a researcher working in clinical trials and interested in downloading and using the tool with public partners and providing feedback please enter your details below and the download link will be supplied. More details on the tool and its development are published open access in Trials journal.

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Team: Suzie Cro and the HEALTHY STATS public involvement group

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