For many years, pharmaceutical companies have focused primarily on patient recruitment when it comes to clinical trial participation. The main challenge has traditionally been ensuring enough patients are recruited to allow the study to proceed and generate sufficient data to demonstrate the efficacy of the investigational treatment.
Patient recruitment has long been a significant challenge. Finding patients willing to commit to a study and establishing multiple sites to facilitate their participation is a complex and costly task – particularly in the case of rare disease drug trials, which may require a large number of sites to enable access for enough patients in widespread locations.
However, recruiting patients is not by any means the end of the story. Approximately 30% of patients drop out of clinical trials, resulting in heavy financial costs. On average, it costs $6,533 to recruit one patient to a clinical study, and the cost of replacing patients is even higher. The average cost to recruit a new patient if one is lost due to non-compliance is $19,533. These figures demonstrate the importance of patient retention, but direct financial losses aren’t the only cost of patient dropouts.
Time is Money
Failure to retain patients can cause costly delays.
When a patient is lost from a clinical study, it means a great deal of wasted time and resources. Studies have shown that 80% of clinical trials are delayed by at least a month, causing potential losses of approximately $600,000 (and potentially as high as $8 million) per day. Trials can be set back by months or even years, depending on the extent of the issues faced and how long it takes to get back on track.
However, the financial impact of patient dropouts increases significantly as studies progress through later trial phases. Industry analyses estimate the cost of losing a patient as:
- Phase 2 trials: approximately $30,000–$70,000 per patient
- Phase 3 trials: approximately $75,000–$150,000+ per patient
- Rare disease or complex trials: can exceed $150,000–$300,000+ per patient
These figures highlight how critical patient retention is, particularly in later-stage trials where each participant represents a significant investment of time, resources, and clinical data.
Patient dropouts also introduce significant operational risks for clinical trials. When participants leave a study, sponsors may face:
- Increased recruitment and site costs to replace lost participants
- Enrollment gaps that extend study timelines
- Downstream delays that impact regulatory submission and market entry
In many cases, each month of delay can represent $1M–$10M or more in lost market opportunity, depending on the therapy area and commercial potential. In rare disease trials, small patient populations magnify the impact of patient dropouts, as a single patient may represent 5–10% of total enrollment.
Read more about why patients drop out of clinical trials.
Loss of Valuable Data
Losing a patient also means losing valuable data. Once they drop out of the trial, the data collected from them is no longer usable, and the process will need to begin again with a new patient. In most instances, this results in delays to the study and wasted time, money, and resources. In the worst-case scenario, this could lead the relevant drug authority to stop the trial due to insufficient results or evidence of viability. Ultimately, the more patients that drop out of a study, the greater the risk that the data collected will be insufficient and lack the required integrity.
Loss of Patient Advocacy
If patients drop out of a trial because they feel they have not been treated well, or their needs have not been listened to and considered, there is a risk they may speak to patient advocacy groups, or take to social media or other public outlets to voice their frustration or grievances.
Patients are now extremely well-informed and connected, and can easily find information about trials and pharmaceutical companies online and through their networks. If a negative experience is communicated amongst influential and tight-knit patient communities in this way, other patients will become wary of participating in future clinical trials. This could make it more difficult – and costly – for your studies to recruit patients in the future.
Impact on Patient Wellbeing
Each patient taking part in a clinical trial is a human being, with complex needs and individual circumstances to navigate. In the case of rare diseases, there may well be additional health complications to be managed alongside participation.
When patients taking part in a clinical trial feel underappreciated, or like their needs are not being met, or like participation in the trial is simply too difficult for them, and they’re forced to drop out, they may be left feeling upset and negative.
Furthermore, associated stresses can be placed on patients as they deal with travel, accommodation, and other logistics and expenses. All these things can have a detrimental impact on patient well-being, which has a real cost beyond a patient dropping out of a study.
In Summary
Patient retention is critical to the success of a clinical study, and the true cost of patient drop-outs goes far beyond the cost of patient recruitment. The time, financial, human, and reputational costs can be vast, the impact can be long-lasting. Repairing the damage after patients have dropped out of a study isn’t easy; therefore, focusing on patient-centricity in all elements of trial design is necessary to mitigate this risk.
It is vital, therefore, to take time at the beginning of the study to think about how best to support patients, and to invest in services that will support patient retention, as ultimately this will save a huge amount of money, protect your reputation, and positively impact the success of future trials.
Read more on challenges and strategies of patient recruitment and retention
Download our guide: How to retain patients in your clinical trial
