Exit interviews

Exit interviews are in-depth qualitative interviews with individuals, conducted at the end, or soon after the end, of a clinical trial to obtain direct feedback on their experiences over the course of the clinical trial

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What can they tell us?

Exit interviews can provide a rich source of information about the individual’s experience and can be highly informative in understanding the true value of study medication or treatment.

  • Offer comprehensive evaluation of the effectiveness of study medication or treatment on
    the individual – symptoms, feelings, functioning
  • Explore the impact of any side-effects and overall balance with treatment benefits
  • Understand the true value and impact of any changes in health status experienced, for example What has changed? How has it changed? What does this mean to the patient?

Why is this useful?

Such information captures the patient voice and it supports value messages for key stakeholders:

  • Regulatory
  • Clinical
  • Payer
  • Patients

The patient voice – the knowledge gained from this -is increasingly being required by regulators to support a comprehensive evaluation of meaningful change thresholds.

What expertise does COS bring?

At COS we are highly experienced at planning, managing, analyzing, and reporting exit interviews in a number of settings:

  • We have a detailed understanding of the when, how and why of successfully integrating exit interviews either within or alongside your clinical trial protocol
  • We have developed innovative quantitative techniques to calculate the qualitative sample size needed for collecting data on meaningful change, for use in regulatory interactions Interviews are conducted by trained, experienced interviewers to ensure richness of data addressing key objectives and analysed by skilled qualitative scientists
  • Pioneering use of clinician ratings of qualitative data to provide additional anchors of change in the qualitative and quantitative analysis

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