Article updated May 2023.
What is patient retention, and how does it affect clinical trials? What are the outcomes of having a low retention rate versus a high one? And how can pharmaceutical companies give themselves a better change for high retention rates in clinical trials?
Regulatory bodies require multiple phases of clinical trials for new pharmaceutical therapies, each with increasing levels of rigor, patient recruitment and retention challenges, and risk versus reward implications for stakeholders, especially patients and trial sponsors.
A clinical study delay due to failure to enroll or high retention failure rates can be harmful to the trial process. This also harms the trial sites and the patient population awaiting a safe and effective new treatment.
What is patient retention in clinical trials?
Patient retention in a clinical trial is defined as the strategy and tactics designed to keep participants enrolled in clinical trials from discontinuing participation and dropping out.
What is the importance of patient retention in clinical trials?
Patient retention in clinical trials is closely tied to the eventual success of the study. Poor retention can be costly and cause a clinical trial to fail for avoidable reasons. (85% of trials fail to reach their enrollment goals in the first place.)
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The average cost of developing a drug is in the billions of dollars, and trial sponsors can lose between $600,000 to $8 million for every day a trial is delayed. When patients discontinue participation in a study, sponsors may need to pause and recruit again – and again, face the 85% recruitment failure rate. This is just one reason many life science organizations focus on better retention throughout their clinical research.
Signing up for a clinical trial is voluntary – patients have the right to discontinue the trial at any time, for any reason, or for no reason. But most of the reasons participants stop or leave a study are avoidable.
Common reasons why patients drop out of clinical trials
Patient recruitment and retention in clinical trials can be particularly challenging. Patients may choose to discontinue trial participation for various reasons, and discontinuation happens often. In fact, the average clinical trial dropout rate is up to 40%.
Some trials have inherent retention barriers. Conditions like Alzheimer’s disease, Parkinson’s disease, and certain types of cancer affecting elderly patients can be challenging. This is because health and economic factors disproportionately affect older people.
There can also be ethical reasons – ethical dilemmas commonly associated with geriatric populations include obtaining informed consent, ensuring patient privacy, assessing decision-making capabilities, using advanced directives, and other serious considerations.
Studies of pediatric diseases have some of the same complex barriers, and as a result, these trials can last for a long time. Ultimately, this can impact funding for the trial and endanger its continuation.
Parents may also be reluctant to enroll children in trials where another treatment is currently available, even if the treatment is only moderately effective. Known outcomes are often preferable to unknown outcomes.
Other typical reasons for dropping out of trials include:
- Inconvenience. Trials can require a lot of time and effort from patients, which can begin to seem like a burden, particularly if the patient is experiencing health issues. Patients who perceive trial participation as a burden may choose to stop. Moreover, because trials are often limited to urban centers, patients in rural areas may need additional engagement methods like virtual tools that are more accessible and convenient. Otherwise, they may be disproportionately impacted or overlooked, leading to negative impacts on retention. Logistical accessibility issues to the site, such as distance, frequency, and costs, may discourage patients from signing up and staying in the study.
- Lack of appreciation. Patient experience also matters. Participants who don’t feel valued during a trial may believe they aren’t making a meaningful contribution or receiving any value in exchange for their time and effort.
- Unclear expectations or no change in the disease state. If patients are part of a control group, they will unlikely show any improvement. If participants don’t experience progress and are not regularly informed of the importance of their continued participation, they can become discouraged and drop out.
- Forgetting or losing interest. Patients may have work, family, and other commitments that compete for their time and resources. Patients may stop attending appointments if clinic visits are inconvenient, complicated, or easy to de-prioritize.
- Fear and anxiety. Patients may not understand protocols or be reluctant to endure additional medical procedures.
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How can life science organizations increase patient retention in clinical trials?
Successful participant retention helps a clinical trial stay on schedule, saving sponsors time, money, and other resources. The higher the rate of retention, the higher the likelihood that a clinical trial reaches its conclusion and its intended endpoints and goals.
Life science organizations increasingly rely on technology to streamline processes and save time and costs. The right technology – tools that work for enrollees, trial sites, investigators, and clinicians – can help trial teams strengthen enrollment efforts, increase trial diversity and inclusion, and be more attentive to patients’ needs in various ways.
One way trial sponsors can lower dropout rates for clinical trials is by focusing on patients and their needs – not just in terms of what they need to do to adhere to participation guidelines, but their need to offer feedback, share their experiences, and be heard. In one study comparing trials with significant patient-centered elements to traditional trials, researchers found that 87% of the patient-centered trials had positive results, much higher than 68% for the traditional trials. Companies that take more patient-centric approaches to trial design and execution reduce average trial enrollment time and shorten the timeline from first patient dose to product launch.
Best practices for insights management and virtual patient engagement
We’ve compiled a best practice guide based on more than a decade of helping teams like yours design effective patient interactions. Download the guide to learn:
- Why virtual engagement is a good fit for patients’ needs, increasing participation and quality of insights
- How patients can participate in product development, including trial protocol design, educational material development, and sharing their treatment experiences
- Best practices for better patient engagement – choosing the right participants, conducting anonymous sessions, developing questions to prompt robust discussion, maintaining confidentiality
- Real-world examples of patient engagement success
Real-world evidence of improved patient retention in clinical trials
Some pharmaceutical and medical device companies already use an insights management platform to approach patient retention in novel ways. One global pharma company wanted to reduce the risk of patients discontinuing a clinical study prematurely. To increase the likelihood of maximizing patient retention, the team set the following goals:
- Gathering feedback from study investigators on best practices, patient assistance services, and study support materials
- Gaining insight into patient and caregiver experiences
- Identifying gaps or opportunities for additional patient support
The pharmaceutical company received feedback from investigators worldwide by engaging investigators in an asynchronous forum. The investigators provided detailed information about patient experiences with clinical site visits, assessment materials, support materials, and other study aspects, and the pharma team got valuable information to improve patient retention:
- Suggestions for clinical site visits to improve the experience for investigators, patients, and caregivers
- Insights on additional patient support materials to increase the likelihood of continued participation
- Feedback on operational aspects of the study to apply these learnings to future studies