It’s well known that some patients who enroll in clinical trials don’t stay to the end of the clinical trial. Sometimes, this is because they die or develop an adverse reaction that prevents them from finishing the trial. But other times, it’s because they simply drop out of the research study before their designated end date. That puts their health at risk since they could miss out on potential benefits while also potentially exposing them to risks they were not aware of beforehand. However, there are strategies you can take in order to improve patient retention in clinical trials and make sure that your study participants finish the trials on time and unscathed.
Patient retention in clinical trials is keeping patients who have signed up for a clinical trial to remain in it until the completion of all stages. Dropouts are when patients who have signed up for a clinical trial drop out of it before its completion. Patient retention strategies aim to improve patient retention and patient satisfaction. Your clinical trial should account for expected dropout rates and discuss different strategies that can be implemented on a daily basis to improve clinical trial patient retention.
Patient retention in clinical trials is a highly relevant and important topic because it’s considered one of several quality measures. A poorly executed study with a high rate of dropouts may give out false results with very little significance due to improper patient-to-result comparisons. Making sure that patient retention rates are high should be a top priority for any trial site. Newer versions of some commercial Electronic Trial Master Files can calculate expected dropout rates and list different strategies that can be implemented on a daily basis to improve clinical trial patient retention.
Having poor patient retention rates will also cause trials to lose funding as it’s a major setback for all parties involved and makes a lot of money wasted from the initial costs of running the trial till completion. Patient retention strategies need to be implemented that could save thousands in funding and give vital insights on different ways how to improve patient retention in clinical trials.
When patients leave a clinical trial early for any reason, that leaves a spot open in the trial. This spot could be filled by another patient, but if that patient doesn’t show up, then there’s still an empty spot on your study. Over time, these empty spots add up and can significantly impact a clinical trial’s results. A study might indicate that a new medication is working well when it really isn’t because so many patients dropped out.
The main consideration of clinical trials patient retention is that you will lose valuable data on any patients that drop out early. You won’t know if what you are giving them works or not. Patients who stay with your clinical trial can provide data to prove how effective your new treatment is over time. Patient retention also shows that patients believe in your product and want to see it succeed, as opposed to leaving because they don’t want to use it any longer.
If you start a clinical trial and patients begin to drop out of it, what effect does that have on your data? One way to assess patient retention is by looking at your time-to-event data. If you have time-to-event data available for your study, you can use that information to understand how many patients dropped out over a certain amount of time. When plotted on a graph, these results can be helpful for understanding if patient retention has increased or decreased from month to month.
Patients drop out of clinical trials for several reasons. Some patients may be given information about a new treatment that is not yet approved and they may want to use it instead. Other reasons could include side effects, which patients decide are just too much to handle. Sometimes a patient simply stops coming to appointments or picking up their medication. Whatever the reason, patient retention in clinical trials is an important issue that must be addressed.
Because clinical trials have clear guidelines for patient dropout rates, such as those set by The Food and Drug Administration (FDA), researchers can also be penalized for too many patients dropping out of their trial. Patient retention in clinical trials is a major issue that must be addressed to keep positive progress going.
The Food and Drug Administration (FDA) has set guidelines for patient dropout rates in clinical trials. The FDA’s goal is to ensure that all participants in a trial receive effective treatment, but sometimes patients may drop out of clinical trials because they are given a placebo. If a placebo is being used, patients will have no side effects or improvement and may become frustrated with what seems like pointless participation.
Patient retention is one of several factors that can affect clinical trial success, including patient satisfaction. Unfortunately, patient retention in clinical trials often has no single solution. However, there are many strategies to help improve patients’ completion of clinical trials.
Here are just a few clinical trial retention tips that may work for your specific needs:
- Increase Awareness of the trial before they sign up. Patients who know they want to participate in a trial generally have better retention rates than those who don’t. You can increase awareness by placing posters throughout clinics and hospitals or advertise through social media such as Facebook and Twitter.
- Offer patient support groups. Patient support groups provide information on what other patients have experienced during their participation in different treatments. Creating a forum where patients can interact with each other and ask questions about the trial protocol will increase interest among people who would like to try it out but were nervous about their participation
- Streamline scheduling. Clients feel more confident knowing exactly when they will be receiving their treatment because they are aware of exactly how long it will take them from start to finish.
Providing patients with a variety of payment options and support for their personal needs can greatly reduce patient disengagement. A good rule of thumb is to provide more than just a single option so that everyone feels comfortable choosing what’s best for them.
Retaining patients in clinical trials is crucial if you want to get results. Those who drop out early on in a trial aren’t just leaving it – they are also taking part of your research with them and making it more difficult for you to obtain results for your study. Therefore, you want to keep patients enrolled as long as possible in order to get accurate data from them.
You may consider reaching out to patients who have prematurely dropped out of the clinical trial to understand why they left. Once you have an idea of which patients are leaving your study prematurely, you can try to address these issues and reduce their number as much as possible.
If a lot of patients are dropping out due to adverse effects or because they simply don’t agree with what they’re doing anymore, then there’s not much that you can do about it and it might be best for them to leave at that point. However, if most people drop out due to logistics or because they want to continue taking part in other studies instead of yours, then you may want to consider adjusting your clinical trial to address their concerns.
As mentioned above, one way that has worked for some clinical trials is including the patients on a message board that is dedicated to the clinical trial. Here they can chat about studies with other people who are also taking part in them. This can give them an extra incentive to stick around until completion, as well as provide them with a good forum for getting answers from others who have taken part in similar studies before. They can discuss reasons why they entered the trial in the first place as well as what is keeping them there. Having that comradery can help encourage patients to continue the trial.
What happens if too many patients drop out of a clinical trial? It could be a result of poor study design. Maybe you don’t have enough patients in your trial to start with, or you might be testing a treatment that’s simply not effective. Alternatively, it could be due to poor patient selection; maybe your clinical trial attracts patients who aren’t well-suited for whatever it is you’re testing. If you think your results are bogus because of low retention rates, don’t rush to blame on patients—look at your own data first.
One important function of patient retention in clinical trials is to ensure that your trial results aren’t compromised. Results may be inaccurate if too many patients don’t participate or drop out, or if too few patients are included in the first place. Although it can be difficult to determine whether your data is good enough, you may want to review past studies using similar treatments and compare them with yours to see whether patient retention rates have been as high as they should be.
It’s important to keep enough patients enrolled for long enough to generate stable data, and if you don’t then you risk biasing your trial’s results. If too many patients drop out, it can make your study difficult to interpret because they may have done so due to your treatment—for example, by getting sicker or showing signs of a bad reaction.
By now, most clinical trial professionals know that one of their main jobs is to keep patients in trials. However, many are unsure of exactly whose responsibility it is to see that a trial continues as planned and on schedule.
At first glance, it would seem that patients are responsible for completing clinical trials. However, patient retention is really a team effort. Though most patients wish to continue with their treatment protocol and complete their studies, they can’t do it without help from others in many different positions – and not just other members of their care team. Patient retention in clinical trials relies on professionals such as doctors, nurses, drug representatives, and case managers to ensure a smooth experience for each patient on each trial!
Having an interested, informed patient is key to patient retention in clinical trials. However, that’s not all that you need. Healthcare professionals can provide further valuable assistance in keeping patients engaged with their studies and eager to continue! If healthcare professionals understand why their role is important – and how they can affect clinical trial patient retention – they’ll likely be more motivated to do everything they can to help patients feel a sense of commitment and motivation towards continuing on their trial treatment.
Most clinical trials work through medical centers and health providers who typically recruit new patients for trials. These physicians tend to be busy and under a lot of pressure from insurance companies and HMOs, so they may not always have time to think about recruiting for clinical trials.
Still, there are ways that doctors can improve patient retention in clinical trials by improving their recruitment tactics:
- Make sure your practice is ready to accept patients for the clinical trial and be able to address common questions about it. You may have an FAQ pamphlet for them to view or a web page that they can go to for more information.
- Doctors should ensure that their facilities are set up appropriately before recruiting begins. This means having written informed consent protocols in place, being able to discuss with potential participants exactly what each trial entails (i.e., what drugs will be used), having proper space available, etc.
Physicians should also recognize that patient retention in clinical trials often requires more than a quick phone call to make an appointment. Sometimes, physicians don’t have time for follow-up calls or lab work. If a clinical trial staff member has already done extensive screening and research about potential participants before presenting a doctor with possible recruits, though, doctors are likely to accept new patients at a higher rate.
Additionally, doctors will usually find it easier to recruit new patients if they offer their own incentive for participating in trials. This could be as simple as paying your patients $50 per month or offering them monthly lottery tickets. Anything that makes research participation feel like less of an inconvenience can increase patient retention in clinical trials by convincing more people to sign up.
If you have a large sample size, and a high patient dropout rate in your clinical trial, use data analytics to figure out what exactly causes them to drop out. Find out if there is a correlation between a specific stage of treatment and dropping out, or if it’s something like side effects.
You can then come up with an intervention plan based on these findings. There are many other tools that can be used to improve patient retention in clinical trials as well. Your clinical trial might be able to benefit from some of the solutions listed here or you may need to brainstorm with your team on ways to help patients that have dropped out of your trial. Consider sending out a survey to those who have dropped out to gather information on why they left.
People have their own reasons for wanting or needing treatment, so don’t be too quick to judge them. Find out what exactly is bothering them, then try your best to help resolve their concerns. You can also use your intake data to help find patients that are similar to those who are staying in the study longer vs those who are leaving earlier to find new patients that are more similar to those who are staying in the study.
Although it’s important to improve patient retention in clinical trials, you shouldn’t solely rely on technology to solve all of your problems. Make sure that you take time to look at issues from a different perspective or talk things over with someone who has worked in clinical trials before. Try not to let any issue get out of hand, as it can be costly for both you and your patients. Your data may tell you something about patient dropout, but don’t forget what got you there in the first place. Use data analytics when appropriate and use common sense when necessary.
Patient retention in clinical trials is an important topic to review. You can use some of the methods outlined in this article to help improve patent retention in your current and future clinical trials. Are there any other methods that you have used in the past to improve patient retention?