5. End of Study
Plain language summaries, results reports and publication of research findings.
At “End of Study,” all procedures and active follow-up visits are finished for the participant. Using health literate communications at the end of a study reinforces trust in the research establishment and demonstrates transparency and respect. End of study activities apply whenever a participant completes the study, decides to withdraw or is taken off for some other reason.
- At “End of Study,” the focus of the clinical research team is on ensuring:
- data collection is complete
- participants end their time in the study in a respectful and orderly manner.
The research study team should plan ahead. Consider what and how to share end of study information with participants early in study development.
- This is a time to express gratitude for the participant’s time and commitment, as well as provide any end of study information that might be interesting and/or useful such as details related to continued access to the study medication, if applicable.
- At “End of Study,” the study team should be prepared to share with participants, as applicable, information such as:
- their own individual study results, if possible to be shared,
- a study status update,
- an aggregate summary of the overall study results once it is possible to do so.
- The clinical research team should disseminate the study results to individual participants and all the communities involved.
- Clinical research participants are interested in sharing their feedback and opinions regarding their study participation. The ‘end of study’ is a great opportunity for the clinical research team to understand the participants’ experiences being in the study. This feedback can be considered in the context of the current trial and any updates that may be reasonable to make for participants moving forward, and when designing new studies in the future.
- Any materials and scripts used at the end of the study should go through usability testing with members of the population of interest.
Click through the individual tabs to learn more about how your “On Study” research communications can be improved through plain language, numeracy, clear design and cultural considerations.
Plain Language
During the “End of Study” stage, communications like individual and overall research results summaries should continue to include the plain language terminology introduced earlier in the study process.
- Any information that may be essential to trial participants after they finish the study (for example, continued access to study medication) should be shared in plain language.
Return of results has been mandated in the EU and is considered a best practice. Click here for the MRCT Center Return of Results template.
Numeracy
During the “End of Study” stage, narrative content and numeric information are often presented together. Numeric information summarizing the study results at the end of the study is as important to communicate clearly as the study information that was shared when a participant was first recruited and consented to the study.
- At the end of study complicated statistical results should be explained, as well as rates of adverse events and side effects.
Clear Design
- Presenting information on the study drug once it is approved using health literacy approaches is also something to consider.
During the “End of Study” stage, clear design techniques can be applied to any additional print materials that support a participant’s understanding of the research study findings.
End of Study Clear Design Example
- Click the “full screen” icon in the top right corner of the image below to enlarge the example.
- Click the plus signs in the image for more information on what makes this document health literate, and how you can do the same in your own materials.
Cultural Considerations
During the “End of Study” stage, is when research participants want to learn more about what the study found and how they contributed to the findings.
- Find out what really matters to the study population through regular engagement – this informs what is shared in the end of study results summary.
- Beyond reporting the primary outcomes, often secondary outcomes or exploratory aims that relate to quality of life or well-being are also of particular interest and may need extra attention.
- Share study findings with community groups and stakeholders that contributed to the successful conduct of the study as a gesture of appreciation and an effort to maintain strong ties to the community.