The traditional trial model offers a number of disadvantages. Some 70% of potential clinical trial participants live more than two hours from a study center. Many patients are unwilling or unable to make such long journeys to participate in a trial, limiting their access to new studies. They may be too unwell, have mobility or childcare challenges that make traveling difficult.
As a consequence, many clinical sites struggle with patient recruitment. Some 85% of all clinical trials fail to recruit enough patients, 37% of investigator sites under-enroll, and 15% fail to recruit a single subject2. Retention is also an issue, with 30% of patients dropping out2. These problems are particularly acute for trials for treatments of orphan diseases - the rarity of these conditions means there is already a very small pool of potential patients, which risks being shrunk further by poor patient convenience. As a result of these recruitment issues, up to 80% of clinical trials are delayed2.
DCTs provide a more patient-centric alternative to traditional on-site trials, with benefits that extend far beyond the ability to overcome COVID-19 social distancing obstacles. They make it possible for the majority of patients that may be unable to travel long distances or even overseas to a clinical site to participate. This can enhance patient recruitment, improve the diversity of the patient pool, and boost patient retention. In fact, pharmaceutical companies report being able to recruit 50% more patients to a DCT than a traditional trial.
With all of this in mind, it is no surprise that some 7% of clinical trials taking place currently have some sort of DCT component being reported within them, up from 3.5% pre-pandemic. We can expect demand for DCTs to remain strong even after COVID-19. They provide a means of supporting the innovation of treatments for orphan diseases - there are currently 791 orphan medicines currently in development4. In addition, through enhanced retention and diversity, they can boost the effectiveness of larger trials.