CBI Scene Blog

Direct-to-Patient, Remote Trials, Site-less Trials, and Digital Trials Different Ways of Saying 'Trial Success' and 'Positive Patient Experiences'

Posted by Evanna Payen on Jul 16, 2018 10:50:58 AM

CBI’s Direct-to-Patient Clinical Trials conference will address all these leading groundbreaking trials and help you keep pace with a rapidly changing frontier regardless of what terminology you utilize. For a quick look at how site-less, remote, digital, and direct-to-patient trials cover the same ground check out the trial definitions from industry leaders below.


1. What is a direct-to-patient (DtP) model?

In clinical trials, a direct-to-patient model allows for drug therapies to be delivered and administered in the patient’s home and/or biological samples to be taken and uplifted from the patient’s home. Depending on the complexity of the trial protocols, patients may take medicines themselves, or rely on a homecare nurse or caregiver for clinical support. Because the direct-to-patient model allows the patient to participate in the clinical trial from home, it reduces the need for them to travel to the investigator site, increasing the likelihood they will agree to participate and decreasing the possibility that they will drop out of the study.

Source: https://www.worldcourier.com/insights/the-direct-to-patient--model


2. What is a Digital Trial?

In biopharmaceutical R&D, disruption is already here. With costs soaring and expectations evolving, we need a better way to conduct the critical activities that bring new treatments to patients. One that’s more efficient, expedient and focused on patient experiences and outcomes. The answer? Digitalization. It’s more than data and analytics. It’s leveraging new technologies to completely transform clinical trials with: Better patient engagement to find participants who will benefit most, and improve their adherence. A digitally empowered workforce with automation to streamline start-up and site interaction. And data-driven decision making that predicts issues before they occur. And it starts with making the right digital bets. That means: Determining the unique needs of all stakeholders. Defining and implementing a digital clinical trial strategy. And evaluating and incorporating learnings back into early R&D. Those who place their bets now will lead the industry in better efficiency, better insights, and better patient outcomes. The question to ask is: Will you disrupt, or be disrupted?

Source: https://www.accenture.com/t20170620T130545Z__w__/us-en/_acnmedia/Accenture/cchange/digital-clinical-trial/Accenture-Placing-The-Right-Bets-Transcript.pdfla=en

3. What is a Site-less Trial?

A siteless clinical trial (also referred to as a remote trial or a virtual trial) is the concept of designing a clinical trial that uses site visits in combination with mHealth or digital technological capabilities to enable patients to complete assessments that would traditionally occur within a clinic1.

Source: https://www.worldwide.com/wp-content/uploads/2016/12/key-considerations-for-siteless-clinical-trials.pdf


4. What is a Remote Trial? 

Driven by this thought process, remote trials are composed of the following components:

  • Patient recruitment using digital approaches;
  • Electronic informed consent;
  • Electronic data capture at the source (eSource);
  • A robust monitoring strategy, including remote risk based monitoring, remote drug adherence monitoring, and telemedicine; and
  • A strong patient engagement strategy to keep patients engaged via the remote trial conduct.

Source: http://www.clinicalinformaticsnews.com/2017/3/2/the-remote-clinical-trial-concept-in-clinical-research-definition-and-opportunities.aspx

To hear how GlaxoSmithKline, Johnson & Johnson, Clinical Trials Transformation Initiative, AbbVie, Takeda, Eli Lilly, Janssen, Tesaro, Bayer, Pfizer, Icahn School of Medicine, Phillips Respironics, Duke University, Epstein Becker & Green and more are using techniques to enhance patient experiences, download the latest agenda and register today.


Topics: Clinical