Up to 40% of patients drop out of clinical trials before completion, and two thirds of studies fail to meet their enrollment goal. Failure to recruit and retain patients in a study can cost between $600,000 and $8 million per day.
As an industry, we must work together to reduce the barriers to clinical trial participation for patients. In this article, we explore ways to increase trial accessibility, boost recruitment rates, and better engage patients at every stage of the clinical trial journey.
The cost of delaying clinical trials
Patient retention is critical to the success of a clinical study, and often when one or more patients drop out, the trial is paused as more patients need to be recruited.
Studies have shown that 80% of trials are delayed by at least a month, and some even years, depending on the extent of the issues faced and how long it takes to get back on track. Millions of dollars in resources and wasted revenue are lost every year to issues around recruitment, retention and engagement.
These figures alone demonstrate the importance of patient retention, but direct financial losses aren’t the only cost of patient-dropouts in clinical trials.
The burden facing clinical trial patients
Despite often volunteering their time to take part in clinical trials to improve outcomes for themselves and others, patients are sometimes unaware of the burdens, financial and otherwise, of trial compliance.
The most common reasons patients give for dropping out of clinical trials fall into four main categories –
- Inconvenience and overwhelm
- Lack of communication
- Feeling underappreciated
- Financial barriers
For CROs, it’s vitally important to plan how best to support patients at the beginning of a trial, and to invest in services that will support patient retention. Not only will this positively impact budgets and resources, but ultimately engaged patients will lead to better clinical outcomes.
How financial pressures prevent enrollment and lead to patient drop out
All burdens to the patient should be a consideration for trial designers, but the financial impact of taking part in a clinical trial deserves special consideration.
The costs of taking part in a clinical trial are high. Patients may face direct out-of-pocket expenses such as the cost of childcare, transportation and lost work, and may also be left with indirect costs if their expenses are not reimbursed in a timely manner.
In addition, the rising cost of living may have a further impact on a patient’s decision to enrol in a trial in the first place. In an already challenging time, we need to ensure we alleviate any additional stressors from the patient from the very first touchpoint.
Travelling to site
The financial burden is increased when participants have to travel to a specific study centre, which may also involve relocation for the entire trial period. The additional cost of participating under these circumstances biases participation to those in higher socioeconomic groups, or those more able to travel. For severely ill, elderly or disadvantaged patients this can be a real barrier.
Patient payments as a barrier to participation
For those participants who are able to meet the financial demands in the short term, there is still a requirement for them to receive prompt reimbursement of their expenses. Putting patients first is an enduring theme of the clinical trial community, and transparency with regard to compensation is an important part of this.
To improve the patient experience, CROs and sponsors should consider automated healthcare payment systems that lessen the risks of patients being left out of pocket. From automated stipends and reimbursements to prepaid cards, there are a variety of electronic payment options available.
Removing burdens to improve retention
In the long term, CROs must adopt a structured approach to ensure that the trial design removes as many burdens for trial participants as possible.
But there are also solutions that firms can adopt in the short term to get started.
- Use tech to automate payments: Offer swift financial reimbursements and stipends not just to the patients who participate in clinical trials, but also to anyone who may need to accompany them
- Set up protocols designed around patient’s needs: Consider a systematic review of all patient costs to identify opportunities to minimise impacts.
- Focus on the patient experience. Provide patients with clear and transparent information about potential trial-related financial burden and resources available to help, such as financial navigation and counselling
Given the clear issues around clinical trials that fail to complete due to poor recruitment, enrollment, and retention, it’s essential to consider the patient burden, with the belief that retention is correlated negatively with patient burden.
Patients are no longer passive recipients of their care. Therefore, to resolve the most common issues around financial burdens, we must ensure patients participating in clinical trials feel valued and supported throughout by putting them at the heart of trial design. By creating a better patient experience we can expect to see improved clinical trial outcomes that benefit everyone.
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