For a long time, pharmaceutical companies have focused primarily on recruitment when it comes to patient involvement in clinical trials. The main challenge has always been to ensure enough patients are recruited to enable the trial to go ahead and provide sufficient data to prove the efficacy of the product.
Patient recruitment has long been a significant challenge. Finding patients willing to commit to a study and set up multiple sites to facilitate their involvement is a complex, 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 alone 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 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.
Loss of Valuable Data
Losing a patient also means a loss of 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 to the relevant drug authority stopping 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 under-appreciated, 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.
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, resource, human and reputational costs can be vast, the impact can 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.