Patient recruitment and retention can be a challenge at various points in the clinical development process. Research suggests these challenges can lead to delays of between 1 to 6 months for most clinical trials. More, 11% of clinical research sites fail to recruit any subjects, with 37% of sites missing their recruitment target to. Worldwide, over 80% of trials don’t enroll their required subject populations on time— leading to a study extension. Introduction of new study sites and increasing costs.
For sponsors, decentralized trials (DCT’s) show promise for boosting recruitment and helping subject retention. According to the FDA, decentralized clinical trials (DCTs) may reduce the burden on patients and sponsors and increase the accrual and retention of a more diverse trial population.
Tools such as eConsent, tele-healthcare, remote patient monitoring, randomization and trial supply management supporting drug delivery to the subject’s home, and electronic patient records (ePRO) allow investigators to connect with trial participants virtually. This new wave of connection options together with local, mobile, or alternative care locations will allow more subject flexibility with procedures able to be performed outside the traditional study sites.
Why partly or fully decentralizing trials improves patient recruitment and retention
Traditionally, clinical studies are designed around investigator sites, and subjects may need to travel long distances to attend site visits. On average, 70 percent of potential participants live over two hours from trial sites. Travel time alone can significantly disrupt daily schedules, as well as burden them with travel costs—leading to patient retention. With DCTs, patients aren’t tied to specific investigational sites, but can attend designated local healthcare providers, monitored remotely via telemedicine, wearable devices, and digital health technologies, or are visited at home by study staff. Allowing more flexibility and decreasing the burden on the subjects leads directly to a lower likelihood they’ll drop out during the course of the trial.
DCTs also promote a wider potential pool of participants, as they remove the need for the subject to live close to investigational sites. This means there is potential for a wider and more diverse pool of patients can volunteer to participate. So, not only is recruitment likely to be faster and more successful than in traditional trials, but sponsors are also more likely to gain richer patient data.
Running a Successful DCT
A 2019, pre-pandemic, Industry Standard Research survey revealed that 38 percent of pharma and contract-research organizations (CRO) expected virtual trials to be a major component of their portfolios. 48 percent expected to run a trial where most activities were conducted in participants’ homes. The COVID-19 pandemic has led to accelerated interest in DCT adoption resulting in responses of 100% and 89%, respectively, a year later McKinsey’s Clinical Operations Roundtable.
Encapsia’s modern platform opens the opportunity for pharma companies to take advantage of DCT options. Its unique architecture supporting trial visits at patients’ homes, easy direct data capture (DDC) anywhere in the world, whilst supporting interaction with patients.
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