In any clinical trial, patient recruitment is essential in order to get the study started. However, patient retention maybe even more important in ensuring that the trial moves through all of its phases successfully. Keeping participants in a trial ultimately helps keep a study on track, saving the site time, money, and resources in the process. So how should we plan for dropouts? In this blog post, we will discuss some common reasons why patients drop out of trials and what can be done to prevent it.
The primary goal of clinical trials is to assess the safety and efficacy of new treatments. In order to do this, large numbers of patients must be enrolled in trials and followed over time. Biostatistics in clinical trials is used to analyze the data after these trials are completed.
Patient Retention in Clinical Trials
Patient retention is a critical part of any clinical trial, and there are many things that can be done to improve retention rates. By taking steps to improve communication, support, convenience, and engagement, clinical trial sites can increase the chances that patients will complete the study. A clinical research organisation in Europe will be a perfect match for your needs if patient retention is one of your main concerns.
As you may know, the clinical trial process is divided into four phases: Phase I, II, III, and IV. In general, patient retention rates tend to be highest in Phase I trials and decrease as the trial progresses. For example, one study found that the patient retention rate in Phase I trials was 87%, while the patient retention rate in Phase IV trials was only 56%. There are a number of reasons why this may be the case.
- One reason why patient retention rates may be lower in later phases of clinical trials is that the procedures become more invasive and the risks increase. For example, Phase I trials usually involve healthy patients who are taking a new drug for the first time. In contrast, Phase III trials usually involve sick patients who are taking a new drug or a new combination of drugs. These patients may be more reluctant to continue with the trial if they experience any side effects or if the treatment is not working for them.
- Another reason why patient retention rates may decrease as a clinical trial progresses is that patient dropouts tend to be higher in trials with longer durations. For example, a Phase III clinical trial may last for several years, while a Phase I trial may only last for a few months. This is because patients may have other commitments that they need to attend to such as work or family obligations. Additionally, the longer a patient is in a trial, the more likely they are to experience fatigue or boredom.
How should we plan for patient retention?
There are a few things that sites can do in order to prevent patient dropouts.
- Given that patient retention rates tend to be lower in later phases of clinical trials, it is important to plan for patient dropouts in advance. One way to do this is to enroll more patients than you need at the start of the trial. This will give you a cushion in case some patients drop out later on.
Additionally, it is important to monitor patients closely throughout the trial and to provide them with support if they need it.
- It is important to explain the risks and benefits of participating in a clinical trial to all patients before they enroll. This will help patients make an informed decision about whether or not they want to participate.
Additionally, sites should make sure to keep in close communication with patients throughout the trial and provide them with updates on their progress.
- Finally, sites should have a plan in place for patient dropouts so that they can quickly replace them with new patients.
Overall, patient retention is critical for ensuring the success of clinical trials. By understanding the reasons why patients drop out and taking steps to prevent it, sites can increase the chances that their trials will be successful.
