Clinical trial attrition: is decentralization the answer?
Clinical researchers stress having high-quality clinical trial data – and rightfully so. Clinical data is prone to bias, and the list of causes can be overwhelming.
Patient recruitment and retention issues rise to the top of the list as they directly impact trial results.
Traditional clinical trials often impose demanding travel requirements and time constraints on participants, leading to dropout rates and skewed results.
Attrition can exacerbate existing disparities.
Meanwhile, the industry seems to favor patient-centricity. The decentralized clinical trials (DCTs) market is expected to grow from $8.3bn to $18.9bn in the next 8 years.
The patient-centric, convenience, and cost savings of decentralization are fueling rapid endorsement.
But does this transformative potential translate to tangible outcomes? And can decentralizing the trial reduce dropout and save data quality and cost?
To answer these questions, let’s first look at what causes attrition in a centralized model.
What causes attrition?
Numerous reasons could be behind a patient’s decision to drop out. Luckily, several studies attempted to find patterns.
One clinical trial in genomics showed that the likelihood of an adult enrolling was reduced by 10% per 30 miles of distance to the enrollment site. Also, the study enrolled and retained fewer minorities, which further biases the results.
Another study showed that complications or having little benefit from the treatment can cause patients to drop out.
With that in mind, can decentralizing the trial address patients’ concerns while maintaining efficiency?
Benefits of decentralized clinical trials
Our clinical study showed encouraging results. The Loop Medical team tested our painless blood collection device: Onflow.
The device achieved a 97.5% success rate in collecting samples, 99.8% compatibility with Roche Cobas analyzers, and 91.4% of patients rated Onflow as painless, proving the efficiency of decentralized blood collection.
The scientific literature also shows optimism around DCTs. One study compared operating in a centralized vs. decentralized model:
Another review followed cardiovascular disease patients participating in a longitudinal study. The authors found that by offering home-based follow-up visits to study participants who couldn’t or wouldn’t come to the site, they were able to save 61 participants (25% of the enrollees) from dropping out.
The genomic study mentioned earlier also highlighted the positive impact of patient centricity. The researchers found that using telephone surveys to fulfill required study activities, rather than using active travel to the site for the final survey, led to high rates of retention at the end of the trial.
What to expect?
The scientific literature supports a broader adoption of the decentralized model in clinical trials.
There’s no debate about the versatility and positive impact DCTs have. But the rally of adoption is only getting started, and we need more evidence and trials on a wider scale before decentralization becomes the new norm.
We also need technology to streamline processes like sample collection. In clinical trials requiring blood samples, needlesticks can be limiting. The sample collection process, needle pain, and sample re-dos can put patients off and cause unnecessary headaches.
This is why Loop Medical pioneered its painless blood collection device: Onflow. Onflow is a simple device that collects blood from the arm within minutes. No special expertise or skills are needed.
Onflow is standardized to fit existing lab infrastructure without sample transfer, overcoming the risk of losing quality.
By 2024, Onflow will help clinical trials decentralize the blood collection process and provide a smooth, painless experience for patients.
Interested in a pilot using Onflow? Contact us today!