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We carried out a study within ICON8 to find out more about how best to communicate trial results to the people taking part in it.

 

Background

We know that many people who take part in clinical trials want to be able to find out the results of their trial. We also know that, in many cases, this does not happen. It can be difficult for trial teams to provide the results to the people who took part. This is for a number of reasons, including:

  • Practical challenges such as losing touch with people
  • Lack of time and/or money
  • Worry about upsetting people
  • Difficulties explaining complex results
  • Protecting the privacy of people taking part in trials
  • Data protection laws
  • Keeping track of people’s wishes on whether or not to be told results

There is little evidence on how best to feedback results to the people who took part in the trial, either from a practical perspective, or on what people taking part in a trial prefer. The evidence that we do have is weak. This means that people running trials do not know how best to do it. The Show RESPECT study was set up to address this.

What did Show RESPECT test?

The Show RESPECT study aimed to find practical ways to share the results of clinical trials with the people taking part in it. It didthis by testing several different approaches within a large ovarian cancer trial (the ICON8 trial).

You can read the full protocol here.

What information did we will collect?

We collected information from people taking part in the trial on how satisfied they are with how the results were communicated to them, including whether they found out the results, how easy it was to understand, and whether it told them everything they wanted to know.
We also collected information from staff working at trial sites on how easy it was to share the results using these methods, how much time it took, and what they think of them.
We also carried out interviews with a small number of people taking part in the trial and research nurses to explore their experience and views on this in more detail.

What did we find out?
  • More than 9 in 10 women taking part in ICON8 wanted to know the results of the trial
  • Sharing results via printed summary seems to be the best approach overall for trials like ICON8:
    • it helped more find out the results
    • people who received results via a printed summary were more likely to be satisfied with how the results were shared than people who found out another way
    • these results were the same regardless of women’s level of education, age, which ICON8 group they were in, or how often they use the internet
  • Most women said:
    • The results were easy to find
    • The results were easy to understand
    • They were glad to find out the results
    • They were willing to take part in future research
    • They were likely to recommend taking part in research to other people 

We have published these results in a peer-reviewed journal.

What recommendations are we making based on our findings?

Recommendations for Clinical Trials Units:
To ensure trials meet their ethical obligations to participants to share trial results:

  • How results will be shared with participants must be considered from the planning stage of trials, to ensure adequate resources are budgeted for and included in agreements with sites, and relevant information is included in the Patient Information Sheet
  • When deciding how to share results with participants, consider the following factors: who the trial population is, the information to be communicated, who should share the results, the resources available for doing this, the tools and process for sharing results, and timing of communication
  • Participants should be offered choice over whether to receive results or not
  • Patient and public involvement is essential for planning how to share results with participants, identifying the outcomes and study results that are important and relevant to participants, and developing the content of results summaries to ensure it is clear and sensitively written
  • Plans for sharing overall trial results should take into consideration whether this is likely to raise questions about individual results or randomised allocation, how these questions will be dealt with and by whom

Recommendations for research funders:

To ensure people taking part in trials they fund get the chance to find out the results, if they want them, research funders should require that:

  • Clinical trial grant applications specify how the research team plans to offer results to trial participants in a way that is appropriate to the study population
  • Clinical trial grant applications include adequate budget to fulfil their obligation to offer the results to study participants
  • Researchers report on how the results have been shared with participants who want to know them as part of their final report

Recommendations for ethics committees:

To ensure that the trials ethics committees oversee meet their ethical obligation to offer results to participants, ethics committees should require that:

  • Researchers specify how they plan to share results with participants in ethics applications
  • Patient Information Sheets contain information on plans for sharing results
  • Researchers report back on the implementation of these plans to ethics committees in their final report

Further resources: