Good Practice Action 8: Assess feasibility

Assess feasibility through pilot studies, integration of qualitative evidence on lived experiences into trial process design, and engagement with local health professionals

A comprehensive approach to feasibility combines practical testing with contextual understanding, drawing on lived experience and local expertise to anticipate barriers and refine trial delivery. Doing this provides a clearer understanding of how delivering an intervention in a real-world setting will go. Without assessing the feasibility through pilot studies, important barriers to the success of the trial will be unseen, leading to failure of the trial.

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Trial teams and others should:

Research teams should carry out feasibility and/or pilot studies assessing practical aspects of trial delivery. Barriers and enablers can be identified, and the trial design can be refined in response to these. An integral part of this is to take account of lived experiences of people living with a disease or condition, including healthcare contexts and perceptions of usual care. By involving local health professionals, the feasibility or pilot study will be grounded in local context, and this helps to support effective recruitment and retention.

These initial studies are designed to test different capabilities of the design, such as procedures, recruitment criteria, willingness of patients to be randomised, variability of outcome measures, logistics, and participant retention rates (Kunselman, 2024).

The following trial components for example can be assessed in a pilot study (Blatch-Jones et al., 2018; Arian et al., 2010):

  • Testing recruitment
  • Determining the sample size/numbers available
  • Follow-up/dropout
  • Hypothesis testing
  • Resources
  • Randomisation
  • Blinding
  • Outcome measures
  • Control group
  • Data collection
  • Further study suggested
  • Dose/efficacy/ safety
  • Clinical outcomes
  • Acceptability
  • Feasibility
  • Delivery of the intervention
  • Testing/developing materials

Integrating qualitative evidence from those with lived experience and taking account of local health professionals is key to trial design decisions that will deliver a successful study grounded in real-world context.

The ILANA study (Farooq et al., 2022) has been highlighted by the World Health Organization (WHO) as demonstrating good practice, with meaningful involvement of people with lived experience at every stage (Hayes et al., 2025).

More resources about building trusted relationships with stakeholders can be found in Good Practice Action 3.

How funders can ensure this happens

  1. Encourage research teams to run feasibility and/or pilot studies first, to optimise the design of the main trial. This could be done by providing funding for this.
  2. Ask research teams to define the learnings from their feasibility and/or pilot studies relating to shaping the study protocol, recruitment and retention strategies, outcome measures, randomisation procedures, as well as development and acceptability of the intervention itself.
  3. Ask research teams about how their engagement with people with lived experience and local healthcare professionals has generated qualitative evidence that can be used to shape the clinical trial design and conduct.
  4. Example questions to ask are also given in the INFORM Structured Grant Form, Questions {6, 7, 21}. Note that many of the questions asked in the Structured Grant Form can be better answered by applicants after a pilot study has been done.
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