There is no doubt that clinical trials are crucial for the development of pharmaceuticals and medical devices.
There is no doubt that clinical trials are crucial for the development of pharmaceuticals and medical devices. Without them, we would not have access to many life-saving drugs and medical devices in the market today. In addition, they are critical to the growth of the pharmaceutical and medical devices industry because they provide revenue streams for these industries when they conduct clinical trials on new drugs and medical devices.
Clinical trials are very important as they test new drugs and devices before they are released on the market. It is only after a drug or device has been tested in a clinical trial that it can be used safely by patients in real-world situations. However, this also means that there is an increased risk of adverse effects (side effects) from new drugs and devices.
They also allow for new treatments to be studied in a controlled environment at various stages of development, including pre-marketing.
Clinical trials help develop new treatments and gain answers to questions about existing treatments. They also allow for new treatments to be studied in a controlled environment at various stages of development, including pre-marketing.
A controlled environment is one in which the participants (participants are those enrolled in the trial) receive a specific treatment or intervention. For example, if you were enrolled in a clinical trial involving an experimental treatment for depression, you would be receiving either the experimental treatment or a placebo (a pill that does not contain active ingredients). You would not know which you were receiving.
Pre-marketing refers to clinical trials that take place after early testing has proven safe enough for use with people, but before FDA approval for marketing can be granted. Clinical trials are designed specifically to answer certain questions about one or more types of interventions, such as medicines and devices:
- Do they work?
- Are they safe?
- How do they compare with other options?
In order to answer these questions, clinical trials are set up so that all participants have an equal chance of being assigned one of several groups: those who receive the intervention being studied (intervention group), those who receive another intervention (comparison group), and/or those who receive no intervention at all (control group).
However, patient recruitment and retention are two of the main challenges in clinical research.
Recruitment and retention are two of the main challenges in clinical research. You’ve probably heard the statistic that only 3% of the population is eligible for trials—but even if an individual qualifies, they may not be willing to participate in a trial due to a variety of reasons:
- The patient’s situation might not permit them to enroll at a site far from their home.
- They could worry about receiving placebo instead of treatment.
- They might simply decide they’d rather stick with what they know is working for them.
While it’s important to make efforts to recruit participants, you also need to keep them engaged in order to reach your study goals. Every dropout increases the risk of bias or compromise in the data, so it’s critical that you find ways to improve patient retention rates throughout your trial lifecycle.
Reasons patients leave clinical trials vary, with many patients simply dropping out due to their current treatment working well enough that they don’t need to stay on the trial.
You should always remember to understand why patients drop out of clinical trials. The reasons may vary. Some patients may drop out because their current treatment is working well enough that they don’t need to stay on the trial. Other patients may drop out due to a lack of communication from the research team, or a lack of understanding regarding the trial and its terms.
This is often an issue early on in trials where recruitment rates tend to drop off significantly during the latter stages.
Another issue for trialists to consider is the possibility that their study intervention may be too effective! Yes, it’s possible for a study intervention to be too effective. We don’t want our interventions to be completely ineffective, sure, but we also don’t want them to reduce the symptoms of the condition being studied so much that participants no longer meet criteria for the condition. If this happens, you’ll have fewer people meeting your inclusion criteria and may even need to alter your data analysis plan.
Overall, researchers have found that 30% dropout rate is not unusual when it comes to patient retention in clinical trials.
When it comes to clinical trials, patient retention is a critical issue that can completely derail the study. While some patients drop out of studies for medical reasons, others simply lose interest and stop participating. With so many variables involved in clinical trials, researchers need to maintain as much consistency as possible. Without adequate participant retention, everything from the integrity of the data to the timeline for approval by regulatory bodies could be at risk.
While there’s a significant amount of research on the subject, no single figure seems to encompass all types of clinical trials. However, researchers have found that 30% dropout rate is not unusual when it comes to patient retention in clinical trials—a number that’s still higher than some other research industries but lower than others. For example, one survey found that 31% percent of patients dropped out within four months in an oncology study—a rate comparable with other studies on cancer treatment but significantly lower than diabetes or cardiovascular treatments. Other industries also face similar challenges: Clinical trials conducted outside the US tend to have higher dropout rates (sometimes as high as 50%), and certain patient populations are more likely to leave a study before its completion (patients under age 18 are twice as likely to drop out).
However, with the right strategies, trial managers can boost patient retention throughout the entire trial period.
You and your team can improve patient retention by creating a welcoming atmosphere for all patients, providing more opportunities for in-person visits, and making the trial as convenient as possible. The earlier you start implementing these strategies, the better.
Here are some strategies for improving retention during each phase of a clinical trial.
Many [organizations] find that patient recruitment accounts for 30% of the cost of running a clinical trial. With the right strategies, you can make sure your study is attracting the right participants, and keeping them engaged throughout.
Here are some strategies for improving retention during each phase of a clinical trial.
Phase 1: Selection
Before patients can be selected for a trial, it’s important to establish clear criteria to determine who qualifies and who does not. In order to avoid wasting time and money on people who may not be able or willing to participate in the entire duration of your study, you’ll need to keep in mind that an ideal candidate will:
- Be available from start to finish
- Be able to travel if necessary
- Have a good medical history
Retention is crucial during every phase of a clinical trial from initial contact to follow-up post-trial.
Retention is crucial during every phase of a clinical trial from initial contact to follow-up post-trial. The presence and severity of trial-related symptoms is a key factor in determining your ability to retain participants, as is patient satisfaction and treatment compliance. In fact, an estimated 30% of all patients enrolled in clinical trials drop out before the end of the study, which can have serious implications for the results of your study.
The importance of retention for biopharmaceutical companies cannot be overstated: poor trial retention leads to delays in bringing new drugs on the market and can even cause a drug candidate to fail because there are not enough participants who completed the trial successfully. For example, if you’re testing a drug that reduces blood pressure, you need at least some patients who are experiencing high blood pressure so that they can receive treatment and show you how effective your drug is at lowering their blood pressure.