Cancer centers have known for many years that clinical trial recruitment is a serious problem. But in recent years, a new phenomenon has appeared: the gradual attrition of patients who seek novel treatments at other facilities.
This article explores the dynamics that lead to low trial accrual and cause organizations to lose patients – before revealing an emerging solution that is helping forward-thinking cancer centers to solve both problems.
Why Cancer Clinical Trial Accrual Faces Challenges
Low cancer trial accrual rates have been a common concern amongst researchers for more than three decades, with a 1990 paper in Cancer noting a worrying incongruity between the number of cancer patients who are willing to participate in trials – and the number who actually get to participate in one.
Extensive efforts have been made to fix the issue, with experts citing communication issues, financial limitations, logistical problems, staffing shortages, and a lack of “physician commitment” to trials as barriers to trial recruitment. But the results have not been promising, with low accrual leading to:
1.Patient Disappointment
More than 50% of all patients want to participate in trials, yet just 7.1% do. This leads to disappointment and frustration for many patients, as they believe novel methods are more effective or maybe a “last chance” for effective treatment.
2. Diversity Issues
Low trial accrual leads to a lack of diversity within patient populations, particularly in terms of ethnicity and age. This makes the results less generalizable and, therefore, slows progress toward effective treatments that will apply to all patients. The most recent AACI/CCAF meeting deemed this such a concern it dedicated an entire summit to the subject.
3. Trial Failure
Ultimately, 20% of trials close early or fail due to low accrual, with the results deemed inconclusive and ungeneralizable when trials don’t meet their accrual targets. However, patients who are enrolled usually still receive the treatment, which makes failed trials very expensive for research centers and pharma companies – potentially making businesses more hesitant to run trials that risk missing their accrual targets.
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How Does Trial Accrual Impact Patient Retention?
While low trial accrual is a major concern for researchers, it also has significant implications for cancer centers from a business perspective. Many leaders are raising the alarm about increased patient attrition, arguing that it may be a direct result of not offering enough clinical trial opportunities.
Historically, logistical barriers such as travel and financial issues have been noted as significant factors in low trial accrual. However, there is evidence that patients are willing to go great distances to receive better treatment, with some cancer centers attracting people from 150 miles away – and in some ways even willing to go abroad for the right trial.
As a result, a growing number of patients are leaving their current provider to seek more options elsewhere. This may be due to:
- Active Opportunities: The patient learns about a trial at another organization and decides to pursue it.
- Negative Perception: A lack of clinical trials leads patients to see your organization in a less favorable light and seek care from an institution with a stronger research reputation.
However, simply launching more clinical trials is not necessarily the solution to this problem – because the demand for trials is complicated.
The Challenge of Patient Dropouts
Despite patients’ frustration with a lack of clinical trial options, there is an apparently contradictory trend of patients dropping out during trials. Roughly 28% of patients will leave trials after they begin, with commonly cited reasons including a fear of side effects, insurance plans refusing to cover costs, and unexpected logistical barriers, such as increased travel difficulties.
However, this is not a rebuff to the claim that cancer centers must offer the most trials to keep patients happy and maximize care quality; it simply points to a common issue that impacts cancer research. Low trial accrual and high trial dropout rates have the same root cause: poor trial design.
The Future of Clinical Trial Design
Trial design criteria are often highly complicated or exacting. Principal navigators are often forced to create inclusion criteria with little insight into the available patient population, which leads to the following:
- Unnecessary Exclusions: Many patients are deemed ineligible despite being willing and available to participate.
- Systemic Exclusions: Many types of cancer are ineligible for almost all trials, with vanishingly few trials available for patients with brain metastasis or those without “measurable disease.”
- Logistical Oversights: Over half of all potential patients are excluded from participating by barriers like cost or travel restrictions.
- Unexpected Problems: Many patients who are initially eligible prove unable to complete the trial – leading to the attrition issues mentioned above.
However, a new approach is emerging that leverages natural language processing (NLP) to enable dynamic trial design. Rather than creating trial inclusion criteria and waiting to see how many patients can be recruited, tools like Inspirata’s Trial Navigator instantly ingest data from your entire patient population and report in real-time how changes to your criteria will impact the number of eligible patients.
The net result? Trials are designed with full visibility of their prospective recruitment success, allowing Principal Investigators to identify counterproductive exclusion criteria and ensure they design trials that are likely to meet accrual targets.
This is already having a significant impact on trial design, with early adopters discovering that it is far easier to fund and run trials when recruitment is less in doubt.
Want to explore how it could help your organization design, fill, and complete more cutting-edge research – and avoid losing patients?
