Clinical trials are behind some of the greatest medical discoveries that we benefit from today. They help researchers in the medical field to discover new treatments and ways to detect, diagnose and prevent diseases.
Beyond that, they help researchers and medical professionals to weigh the side effects of a potentially helpful treatment against its benefits.
This article delivers an in-depth look at clinical trials, the common issues that affect them, and the possible solutions.
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One of the most significant issues in clinical trials is patient retention. Patient retention refers to the strategies that help to keep the patients who have enrolled in the trial and prevent them from dropping out.
Studies have continually shown that it is not easy to retain patients in these trials and according to recent data, only 7%¹ of patients who enroll in a clinical trial make it to the end.
Why patient retention is important
While patient recruitment is necessary for starting a clinical trial, retaining the patients is even more important. Retention promotes the likelihood of successfully completing the study, and saves everyone involved both time and money.
Current issues in patient retention
The first reason for poor patient retention in clinical trials is recruitment issues. According to a recent report by Biopharma Dive², 85% of all clinical trials fail to recruit enough patients, and 80% are delayed due to recruitment problems. Meanwhile, dropout rates are consistently high.
The second problem in clinical trials patient retention is an inability to keep patients once the recruitment goals have been achieved. It is the investigator’s duty to retain patients and unfortunately, some patients drop out due to the way they are treated by the investigators.
55% of researchers who participated in a National Institutes of Health³ study believe that investigators' inability to provide a dedicated approach toward a patient is a prime reason as to why so many participants drop out.
The study also includes these additional insights from the researchers:
44% of the researchers say fear of possible side effects has a moderate effect on dropouts, while 34% believe it has a great effect
47% believe patients fear the procedures
36% say patients' unwillingness to move away from their current residence and poor compliance are reasons for poor patient retention
27% cite insufficient support from family doctors and loved ones
9% say the media's portrayal of clinical trials in a bad light and drug inefficacy cause patients to withdraw.
Beyond these reasons, patients may fear that they'll be placed in a placebo-controlled group instead of the preferred active treatment group. As a result, they believe that they will not get the best available care.
A patient may also be non-adherent. That means they fail to comply with taking the prescribed medication and keeping up with other requirements, including diet, keeping a diary, or answering follow-up calls, as advised.
Similarly, because patients have other responsibilities, clashing or inflexible schedules are also barriers to patient recruitment and retention in clinical trials.
A closer look at the main reasons for dropping out of clinical trials reveals that it is often some form of inconvenience for the patient.
With this in mind, clinical trial sites can work toward eliminating these inconveniences. For example, academic medical centers are the most commonly used sites for clinical trials, which can present some inconvenience for participants.
Prime challenges presented by these centers are physical access and clashing schedules. Data from the Association of Research Professionals suggests that well over two-thirds⁴ of Americans live two hours away from these centers.
On top of it, people who follow a regular working schedule in households with an income of less than $50,000 annually are nearly 27%⁵ less likely to take part in a clinical trial than those who earn more than that.
The solution lies in providing hybrid trials so a patient can choose between checking in from a convenient location or attending a facility, without taking time off and thereby losing income.
Another thoughtful intervention can be providing parking. That removes the inconvenience of having to search for and potentially paying for parking.
In some cases, study protocols can minimize the number of tests. For example, if a trial requires blood tests, minimizing the frequency of the tests results in fewer visits to the facility.
The most thoughtful intervention yet is providing easy-to-understand information. This starts from ad-placements in the recruitment stage to consent material, and every other piece of information afterward, ensuring patients have minimal doubts regarding the trial. In fact, difficult-to-understand consent material is the reason behind about 35%⁶ of dropouts.
Written material should be easy to understand for people across different educational levels; the average American⁷ reads at the level of a seventh or eighth-grader.
The binding agent in patient recruitment and retention in clinical trials is trust. If a patient and their loved ones have a good understanding of the process and believe that the clinical trial will be beneficial to them, they are more likely to enroll.
It's crucial to maintain this trust by engaging patients throughout the trial so that they feel like an important part of it and not a means to an end. This also makes them feel like the clinical trial is the right match for them.
At HealthMatch we understand how important access to the right healthcare is to you and your loved ones. We make access to clinical trials quick and efficient.
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