All those responsible for running and overseeing a study should, at appropriately regular intervals, review summarised data about participation changes in the study.
This allows them to identify common issues or developing trends in study participation, and reasons for these trends, so that timely and targeted action can be taken.
Those running and overseeing studies should also consider reviewing information about the participation changes of individual study participants, if this might be important for their study.
Those responsible for running and overseeing how a study is run routinely look at all aspects of how well the study is progressing. The frequency of these reviews depends on the nature and risks of each study.
These regular reviews should include useful, consistently-collected data about study participants stopping or reducing their participation and why this is happening.
This data should be presented separately for the different treatment groups, where this would be helpful and where those reviewing the data are allowed to see information split up in this way.
Reviewing this data might show that some action is needed, for example if lots of study participants are stopping study participation early, or if there is a big difference in the number of participants stopping early in the different treatment groups.
Decisions about what action to take should be made by those responsible for running the study, with the help of study statisticians and patient involvement contributors.
Proactive changes could benefit participants by, for example, making the study less burdensome to take part in.
Any changes made to the way the study is run should be designed to benefit the research by helping to ensure as much relevant and accurate data as possible is available for the study analyses.
This in turn can help make the study results as reliable as possible. Additional data reviews later on can help show whether the actions taken have had any positive impact.
Those responsible for running and overseeing studies should also consider, before they start a study, whether or not it might be useful to review more detailed information about individual participation changes. They can do this by, for example, reviewing participants’ medical notes.
When they are deciding whether or not to do this sort of check, they should consider things like the nature of the study and its participants, the study design, and the risks to participants’ rights and to the study’s integrity.
Review of detailed information about individual participants can help them to check that participants’ wishes about how they want their participation to change have been correctly recorded and carried out.
They can also check that participation changes have generally been handled in ways that do the best by individual participants and by the study.
Other important considerations
Data collected and reviewed while the study is still ongoing should be interpreted with caution as it may not yet represent a full picture of participation changes in the study.
Relevant PeRSEVERE resources:
- See risk assessment and monitoring for more specific guidance on this topic.
Relevant PeRSEVERE principles:
- The actions taken in response to review of the data might include new or different training for study researchers. See principle D6 for more on this.
- This ongoing review of studies is dependent on having good quality data about participation changes. See principle M1 for more on this.
- The monitoring activity and actions taken in response to any findings should be guided by statistical considerations in the study. See principle R1 for more on this.
- We use the term “running” a study here to mean all activity involved in making a study happen, including getting the relevant approvals to start the study, working with the NHS and other organisations to set up study sites where participants will be recruited, making decisions about the management of the study, collecting and processing study data, and so on.
- Data collection: this means the act of adding relevant data onto study forms or systems, to make the data available for running and analysing each study. It does not refer to any separate tests or procedures used to generate the data in the first place.
- Treatment groups: many types of research study involve comparing groups of participants taking different treatments, to see which treatment which might be better.