Traditionally, when patients want to participate in a clinical trial, they need to follow a conventional model that revolves around one central site. But with a decentralized clinical trial (DCT), patients have better and more convenient access, increasing participation and retention.
DCTs are studies executed through telemedicine and mobile/local healthcare providers. The processes and incorporation of modern technologies separate DCTs from the traditional clinical trial model.
Here is a full breakdown of decentralized clinical trials and how they benefit everyone involved.
Similar to your traditional clinical trial, patients gain access to medicines and treatments that’ll be used for data collection. Where a decentralized clinical trial differs from a traditional model is where the treatment administration and collection occur.
DCT services allow patients to stay in the comfort of their homes while participating.
This allows sponsors and CROs to introduce convenient and efficient methods to participants while also collecting meaningful data.
The traditional model for patients can be burdensome, forcing some people who would otherwise benefit from participation from ever entering. Here are five challenges patients face.
In traditional trials, patients need to navigate back and forth to the clinical trial site for every visit.
These trips add up over time and create a difficult decision for some patients. They’re left thinking, “Is my health worth the back and forth?” To highlight this point further, one study in the Oncologist journal showed the median one-way travel distance was over 25 miles.
The same study showed patients in lower income brackets traveled even further (58 miles).
Patients with chronic disease and cancer may already struggle with the cost of care, but these can be exacerbated by traditional clinical trial participation.
Between transportation, lodging, child care, and lost wages due to gaps in work—it’s not hard to imagine why some patients don’t sign up or stop showing up.
Time is more than money. Outside of missing work (and wages), patients lose out on personal time. They don’t get to spend as much time at home, at school, or at family engagements. When you factor in distance and travel methods, a patient could spend a full day attending a single trial visit that only requires an hour of actual on-site participation.
Clinical trial participation can take patients away from their work, which means lost wages. This puts a larger strain and burden on patients and is especially problematic for lower-income patients.
Many patients are the heads of households or are the primary caregivers. It’s not always possible to find affordable child care. The choice may be between their health and taking care of their family.
Every patient journey starts with the consent and enrollment process, where patients can choose between traditional participation or a hybrid method. From there, patients who choose the latter option can set up a schedule that works for them (as long as protocols allow). There may even be chances for visits to take place at the participant’s workplace.
During the trial, patients will be assigned a nurse who will conduct several aspects of the study. This gives patients a trusted face to work with. It also allows for a greater deal of trust to be built between the patient and the nurse assisting them.
Once samples are ready for collection, patients have a choice of letting a courier collect them from their homes, or they can take them to a local lab. Finally, all data is documented, reviewed, and sent to the site according to protocol.
COVID-19 impacted the viability of clinical trials, suspending them due to the global pandemic. One group found that since the beginning of January 2020, about 1,000 organizations have reported a disruption. By May 2020, 1,162 trials were suspended.
Thanks to modern processes and technology, organizations can safely continue their trials with patients. Smart devices allow patients to record and send updates that make data collection easier for everyone. This data can also be collected at local healthcare facilities, ensuring patients don’t have to travel long distances each time.
Our ICH-GCP-certified nurses are prepared and trained to conduct several parts of the study. With extensive experience conducting studies and caring for diverse groups of patients, nurses become an extension of the clinical trial site itself. They also provide familiarity with their patients, increasing the level of trust between patients and care providers and the quality of data collection throughout the trial.
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