Decentralization meets Today’s clinical Trail

Decentralized clinical trials (DCT) was in existence for some time. However, COVID-19, the global pandemic has fundamentally escalated the reception of decentralized clinical trials as medical resources became consumed by SARS-CoV-2-related care. Travel became restricted by physical distancing. Institution of either a full or partial lockdown worldwide, and an increase in clinical trials conducted remotely and at participants, homes were seen. It was already taking a lot of effort to find and enroll subjects in trials, both large-scale trials, and trials where the pool of potential participants is relatively small.

How, then, to guarantee that enrolled subjects could still receive their dose under the everchanging circumstances?

Clinical trial decentralization has played a crucial part in this pursuit. A decentralized clinical trial approach utilizes innovation and technology rather than traditional trial practices, leaving choices for subjects who could not travel to the research site. It involves bringing an increasing proportion of a trial’s activities to the trial participants rather than using the traditional paradigm of bringing trial subjects to a trial site while remaining as patient-centric as possible. The pandemic has elevated the need for virtualization in both trial participants and trial contexts. Sponsors have also recognized the need to enroll a more geographically diverse pool of participants, representing a range of ethnic groups as well as ages and genders. Further facilitating better patient engagement and empowerment, as well as data capture. Decentralization broadens trial access to reach a larger number and potentially a more diverse pool of patients. DCT technologies such as electronic consent, mobile technology, telehealth, remote subject/data monitoring, wearables, sensors, electronic patient-reported outcomes (ePRO), an electronic trial master file (e-TMF), electronic medical imaging, etc. allow investigators to stay connected to participants in research without in-person visits. Decentralized trials can be ‘hybrid’ trials and need not be 100% virtual. These trials can maximize patient-centricity and encourage the transformation of healthcare and clinical research. Moreover, they offer the flexibility needed to enable higher patient inclusion without geographic limitations, balancing patient engagement with data integrity which yields higher satisfaction outcomes. Though not all disease conditions or study designs are DCT-friendly, there are several trials that can use decentralization design by being either entirely or partially virtual in a hybrid model. There are many operational, ethical, and regulatory benefits of conducting a decentralized clinical trial. That includes timely data collection, increased capacity for additional sites, greater control and comfort for participants, improved data quality, and clinical trial continuity

Some key benefits of Decentralized methods:

  • Enables virtual enrollment and participation of a more diverse trial participant population.
  • Improves patient recruitment and retention.
  • Increases patient compliance through eSuite services such as remote screenings, televisits, and user-friendly data capture devices.
  • Deploys direct-to-patient services such as transportation, shipping, and in-home or mobile-nursing visits.
  • Patients can report safety-related information in real-time, along with the quality-of-life parameters. Improves reliability and data integrity.
  • Capturing data directly from patients using technology such as mobile phones, wearable devices, bio-sensors, and electronic patient-reported outcomes (ePRO) eliminates manual data entry. It keeps data organized and safe by reducing errors.
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