The stressful process of carrying out a clinical trial starts with recruitment; but once you’ve cracked recruitment you’re then faced with the problem of keeping your participants in the study.
Why is poor patient retention such an issue?
Without good retention rates, recruitment rates really don’t matter. If you recruit 100 patients and only collect data from 10 of them, in the eyes of regulatory bodies, you’ve really only got 10 people in your study. Needless to say, that’s not great.
Poor retention means missing data, and in the long run, low quality data. With low quality data it’s very difficult to gain the approvals needed to get your drug to market.
Think about it; why did so many people drop out of your study? Maybe it was because the drug had such bad side effects that they stopped taking it. Without data to refute or support that idea, regulatory bodies are unable to make informed decisions.
How do we improve patient retention currently?
The research to back up how we carry out patient retention currently, is sparse. Largely we base this process on what we think works, and what we think patients might want or need in order for them to stay engaged with the trial.
Lots of companies now send out newsletters to patients to keep them up to date with details of the trial. Sending out newsletters not only takes time away from the trial team, it costs money. We have no solid evidence that newsletters increase patient retention rates.
Other methods to improve retention include sending appointment reminders, and emphasising the benefits of staying in the trial when patients attend. Again, these practices demand time and money.
Ultimately, we need to improve the way we follow up our patients.
How can data help?
Trials that require patient involvement for a long period of time are particularly tricky, which is why these types of studies are now looking to use the data from Electronic Health Records (EHRs) to improve their retention rates.
Linking EHRs to trial databases means that data can be collected automatically without the patient needing to attend clinic visits. Of course ethical approval and patient consent for this practice is needed, but it allows trial teams to maintain the collection of critical data points over a longer period of time. These critical data points can be as simple as life/death, but could also include number of hospital stays, side effects and whether the patient has had a flare-up of their disease or condition since taking a new drug.
Ignite Data are able to offer this service to clients, ensuring that regulatory bodies have a high quality data set that represents as many patients as possible.