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Direct-to-Patient Clinical Trials: How COVID-19 Gave DtP a Boost

Many product and service delivery models have evolved to meet changing market conditions brought on by the world-wide pandemic. Clinical trial logistics are no exception, and the way future trials are conducted may be very different due to lessons learned over the last year. While not a new concept, Direct-to-Patient clinical trials provided a way for at risk individuals to participate in clinical trials without needlessly increasing their risk of contracting COVID-19 by traveling to and physically appearing at a trial site.

Definition

To put it simply, Direct-to-Patient (DtP) clinical trials shift the model of delivery from one where the participant comes to a trial site to receive an investigational medicinal product (IMP), to one where the IMP and trial process comes to the participant.  The benefit of a DtP process is a reduction of the burden placed on participants to physically appear at a trial site. A downside of DtP is the relinquishing of some direct control of the clinical trial process, and a greater reliance on participants to correctly follow procedures of the trial. DtP is often also referred to as a Decentralized Trial. The structure of a DtP model varies depending on the requirements of the trial, and the ability of participants to complete tasks according to the trial guidelines. There are models where the IMP is shipped right to the patient’s home, and models that combine the delivery of IMP to the home with traditional site visits.

As Usual, Technology is Paving the Way

Advancements in electronic monitoring devices is helping bridge the gap when it comes to oversight of clinical trials. As stated previously, a big drawback of DtP models is the surrendering of some control over the process. But active and passive monitoring and drug delivery capabilities are compensating for this in many instances. Clinical trial personnel now have access a variety of remotely monitored physical data from trial participants, in real time and recorded history. Dosage reminders can be communicated electronically, and patients can confirm taking medicines back to trial sponsors.  In some cases, medicines can be automatically delivered into a patient’s body via remote dosing devices. You probably participated in more than a few ‘Zoom’ or other online video meeting services over the last year. Well, this same technology now makes it possible for trial patients to be ‘seen’ by doctors, nurses, and other specialists, providing valuable interaction and communication between trial participants and sponsors.

Higher Participation Levels

Recent surveys have indicated DtP is positively impacting clinical trial participation levels. It certainly makes it more accessible for patients to participate.  There is no longer the need to arrange travel, in some cases far from home, to take part in a trial. For patients afflicted with debilitating conditions, this can be a major hurdle to participation.  Even for more able-bodied patients, the travel factor, and the inevitable conflicts with work and personal schedules, is often enough to swing the pendulum toward not participating.  And there is the cost issue. The cost of travel to clinical trial sites is usually borne by the participant, and often is not covered by insurance. The DtP model makes trials much more accessible to people who do not have the financial resources to travel to a remote trial site, and to pay for lodging for the time required of them.

The Future of DtP

Again, the concept of DtP is not new. But the COVID-19 pandemic forced clinical trial sponsors to really ramp up decentralized trial processes to protect patients with compromised immune systems from becoming infected. Conducting so many trials in this manner shortened the learning curve and brought more innovation to the DtP model. It likely showed sponsors of clinical trials that many projects can be conducted as DtP without sacrificing study quality and levels of participation.  Indeed, it may facilitate participation. The experts at AWT Healthcare have provided label solutions for both DtP and centralized trials.  If you have questions about labeling for your projects, we’d welcome an opportunity to assist you.

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“HeArt of the Dragon”: Rebellium Wines Community Collaboration Project

This project, spearheaded by Blake Barrios, a talented artist and proprietor of Rebellium Wines, was not just about creating beautiful labels. It was about empowering local youth and supporting community initiatives. Blake’s vision to mentor these teens and guide them through creating a mural, which was then used as the wine label design, was truly inspiring.

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Many product and service delivery models have evolved to meet changing market conditions brought on by the world-wide pandemic. Clinical trial logistics are no exception, and the way future trials are conducted may be very different due to lessons learned over the last year. While not a new concept, Direct-to-Patient clinical trials provided a way for at risk individuals to participate in clinical trials without needlessly increasing their risk of contracting COVID-19 by traveling to and physically appearing at a trial site.

Definition

To put it simply, Direct-to-Patient (DtP) clinical trials shift the model of delivery from one where the participant comes to a trial site to receive an investigational medicinal product (IMP), to one where the IMP and trial process comes to the participant.  The benefit of a DtP process is a reduction of the burden placed on participants to physically appear at a trial site. A downside of DtP is the relinquishing of some direct control of the clinical trial process, and a greater reliance on participants to correctly follow procedures of the trial. DtP is often also referred to as a Decentralized Trial. The structure of a DtP model varies depending on the requirements of the trial, and the ability of participants to complete tasks according to the trial guidelines. There are models where the IMP is shipped right to the patient’s home, and models that combine the delivery of IMP to the home with traditional site visits.

As Usual, Technology is Paving the Way

Advancements in electronic monitoring devices is helping bridge the gap when it comes to oversight of clinical trials. As stated previously, a big drawback of DtP models is the surrendering of some control over the process. But active and passive monitoring and drug delivery capabilities are compensating for this in many instances. Clinical trial personnel now have access a variety of remotely monitored physical data from trial participants, in real time and recorded history. Dosage reminders can be communicated electronically, and patients can confirm taking medicines back to trial sponsors.  In some cases, medicines can be automatically delivered into a patient’s body via remote dosing devices. You probably participated in more than a few ‘Zoom’ or other online video meeting services over the last year. Well, this same technology now makes it possible for trial patients to be ‘seen’ by doctors, nurses, and other specialists, providing valuable interaction and communication between trial participants and sponsors.

Higher Participation Levels

Recent surveys have indicated DtP is positively impacting clinical trial participation levels. It certainly makes it more accessible for patients to participate.  There is no longer the need to arrange travel, in some cases far from home, to take part in a trial. For patients afflicted with debilitating conditions, this can be a major hurdle to participation.  Even for more able-bodied patients, the travel factor, and the inevitable conflicts with work and personal schedules, is often enough to swing the pendulum toward not participating.  And there is the cost issue. The cost of travel to clinical trial sites is usually borne by the participant, and often is not covered by insurance. The DtP model makes trials much more accessible to people who do not have the financial resources to travel to a remote trial site, and to pay for lodging for the time required of them.

The Future of DtP

Again, the concept of DtP is not new. But the COVID-19 pandemic forced clinical trial sponsors to really ramp up decentralized trial processes to protect patients with compromised immune systems from becoming infected. Conducting so many trials in this manner shortened the learning curve and brought more innovation to the DtP model. It likely showed sponsors of clinical trials that many projects can be conducted as DtP without sacrificing study quality and levels of participation.  Indeed, it may facilitate participation. The experts at AWT Healthcare have provided label solutions for both DtP and centralized trials.  If you have questions about labeling for your projects, we’d welcome an opportunity to assist you.