Clinical Trials Ontario

Participant Experience Toolkit

Participant Experience Surveys

Participant surveys may improve trials through collecting and implementing feedback from participants in the trial. Surveys may be implemented at different time points, including pre-study, mid-study, and post-study. If surveys are implemented, it is important that feedback will be used in a meaningful way to improve the study and its processes.

 Content

  • Work with patients and caregivers to determine the survey questions, the language level, etc. CTO has resources to help you engage patients and caregivers here.

  • Focus questions on the study process, procedures, and experience only, rather than duplicating questions in study surveys.

  • Focus questions on aspects of the study experience that the sponsor or site has the ability to change.

  • If possible and relevant, look for ways to incorporate caregiver feedback into participant surveys (e.g., if a caregiver is required to attend study visits).

  • Surveys should be easy to understand, access, and complete.

  • Incorporate some open-ended questions, allowing participants to give feedback that may be meaningful to them and that is not otherwise captured in the questions.

  • Surveys may need to be translated to the same language used for the consent form.

Process

  • Depending on the study, more surveys may be a burden to participants. 
  • Minimize the time required to complete a survey and see if the logistics related to completing surveys in stages is possible. A survey should take no more than 5-10 minutes to complete.
  • The survey should be available to the participant to complete at a convenient time. For example, during a wait for study visits or tests.
  • Implementation of digital surveys may cause issues for participants without access to technology or who have issues with technology. If someone does not have access to technology, a paper survey, or the option to complete the survey on a device at a site visit may be options.
  • An alternative to a survey may be a review meeting (pre, mid, and post-study) with a trial team member, keeping in mind the relationship of the participant to that trial team member and the potential for complete or honest feedback.

Timing & Frequency

  • A pre-study survey may be helpful to identify participant needs and expectations before the trial begins.

Follow-Up To Survey Feedback

  • Determine how feedback from surveys will be used to improve the participant experience in the clinical trial and ensure that there is a plan for a timely response and implementation of feedback.

Additional Considerations

  • Individual, identifiable feedback should be collected by the trial team. Unidentified, aggregate feedback should be provided to the sponsor. Anonymous feedback should be the default unless there is a desire by the participant to allow provision of contact information for follow-up on any concerns.
  • Ensure that the Research Ethics Board has reviewed the survey tool and plan for implementation of the survey.
  • Study Participant Feedback Questionnaire Toolkit (Transcelerate Biopharma) is a survey developed by a broad group of clinical trial stakeholders that can be utilized at different points in a study to improve the participant experience. The survey can be downloaded and used by anyone.
  • ResearchKit (Apple) is an open-source framework for utility in medical research. The survey function is a core component of this framework and can be customized to collect participant feedback within the context of a trial.

Note: This resource list is not exhaustive and listing a resource does not denote its endorsement or promotion.