Decentralization Meets Today’s Clinical Trial Needs

 

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.

 

The Patient Journey in a Decentralized Trial

 

The journey for the decentralized clinical trial path for patients involves enrollment, randomization, and distribution of investigational Medicinal Products(IMP). Data capture at multiple points directly from patients through wearable technology and sensors allows the patient to be studied in real-life situations. Decentralization capabilities enroll a more diverse trial participant population remotely and facilitate the real-time connection of patients with investigators. Further, allowing more secure experiences throughout their clinical trials.

In a decentralized trial, the use of electronic signatures (eConsent) in place of a physical or wet signature has been implemented. As eConsent is easier to use and understand, can be applied on-site or remotely, and is faster and secure. Additionally, AI (Artificial Intelligence) and ML (Machine Learning) have the potential to transform clinical trials, creating a more reliable and secure method of trial randomization. Even in patients who give consent, an alarming dropout rate across all clinical trials has been observed. However, the dropout rates could be significantly declined by reducing the burden of travel from the patients. Initiation of IMP dispensation from a depot and enabling Direct-to-Patient (DTP) shipmentssolve the challenges associated with continued site visits and site supply responsibility.

In decentralized trials, data reliability and integrity have been achieved through agile technologies, including wearable watches and biosensors, In-home devices, and data-capturing tools such as eCOA and eCRF. These tools provide studies with faster and more accurate data with little to zero transcription errors. With Remote Source Review, the clinical research associates are alerted as soon as the errors are detected, allowing them to virtually access and review the source document.

Ultimately, Decentralized Clinical Trials address an opportunity to reevaluate the conventional clinical trial model while keeping the patient at the center of this arising worldview. Sponsors have seen the advantages DCTs and patients genuinely value the booming flexibility and comfort.

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