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May 18, 2022

Patient retention in clinical trials

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?
patient retention in clinical trials

Patient retention is closely tied to the eventual success of a trial. Poor retention can be very costly and result in failure. The average cost of developing a drug is in the billions of dollars, 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 – one of the reasons many life science organizations focus on better retention throughout their clinical research.

What is patient retention in clinical trials?

According to the National Library of Medicine, 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?

Participant retention helps keep a study on schedule, saving trial sponsors time, money, and resources. Any clinical study delay can be harmful to the study process and the site as a whole.

One way that 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.

Signing up for a clinical trial is voluntary – patients have the right to discontinue the trial at any time, for any reason, or no reason. But most of the reasons participants stop or leave a study are avoidable.

Related content: discover how to achieve patient-centric trials

Common reasons why patients stop and drop out of clinical trials

Patient recruitment and retention in clinical trials can be particularly challenging. It’s important to consider passing a clinical trial feasibility assessment before starting recruitment. 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%, and as many as 85% of clinical trials fail to retain enough patients to move forward.

Typical reasons for dropping out 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.
  • 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, 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. If clinic visits are inconvenient, complicated, or easy to de-prioritize, patients may simply stop attending appointments.
  • Fear and anxiety. Patients may not understand protocols or be reluctant to endure additional medical procedures.

How can life science organizations increase patient retention?

Life science organizations increasingly rely on technology to streamline processes and save time and costs. Technology can help trial teams strengthen enrollment efforts, increase trial diversity and inclusion, and be more attentive to patients’ needs in various ways.

In the real world, some pharmaceutical and medical device companies are using technology like insights management platforms to approach patient retention in novel ways. If you’re interested to learn how are patients recruited for trials, take notes from the following story. One global pharma company wanted to reduce the risk of patients deciding to discontinue 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

By engaging investigators in an online forum, the pharmaceutical company was able to get feedback from investigators around the world. 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

Want to learn more about prioritizing patients to strengthen study design? Read our blog post.



National Library of Medicine. Recruitment and retention of the participants in clinical trials: Challenges and solutions.

PMLive. 5 reasons clinical trial drop-out rates are on the rise.,their%20likelihood%20of%20dropping%20out.

Advarra. Retention in Clinical Trials: Keeping Patients on Protocols,and%20resources%20in%20the%20process.

Economist Impact. State of patient centricity 2020: Advancing from patient-first intentions to true co-creation.

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