Article: The Direct to Patient Model: Your Top 10 Q&A
This article was updated on June 11, 2019
1. What is a Direct-to-Patient 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. Similar Direct-to-Patient models are also effective for commercial therapies, such as chronic illness and lifesaving treatment programs.
2. What are the major differences between Direct-to-Patient and traditional clinical trials?
In the traditional clinical trial model, everything revolves around the investigator site. Patients, must travel to the site. Challenges for trial sponsors include: finding a site close enough to the relevant patient pool and gaining patient commitment. The latter challenge can mean asking patients with challenging disease profiles or schedules to travel frequently to sites far from their home, as well as the patient potentially paying for all the related travel expenses. This can significantly impact patients’ lives, which often leads to their reluctance to participate or high dropout rates once recruited. The Direct-to-Patient clinical trial model eliminates those detractors for patients, putting them rather than the sites at the center of the clinical trial process in a patient-centric model.
3. How does a Direct-to-Patient model benefit clinical trial patients?
The Direct-to-Patient clinical trial model makes life easier for patients and their families. They don’t have to make numerous trips to investigator sites that are potentially a long way from their home. This is especially helpful for patients who may be too sick to travel or for those who live a great distance from hospital sites. Plus, patients can be more in charge of their schedule in relation to the trial.
Our experience has shown that out-of-home trial visits; especially if they have to return home with large quantities of drug supplies - often with temperature control issues - be reduced by more than half. The Direct-to-Patient model is particularly advantageous for trials involving rare diseases or paediatric treatments and patients across many therapeutic areas that cannot easily travel to sites, whether due to illness or other factors.
4. How does a Direct-to-Patient model benefit trial sponsors?
The Direct-to-Patient model quells the two largest issues plaguing clinical trials: patient recruitment and retention. Because patients are assured of potential time and cost-savings as well as additional conveniences when participating in Direct-to-Patient clinical trials versus traditional studies, use of the model has increased patient recruitment by up to 60 percent and helped maintain patient retention at over 95 percent. The drug development community can also gain access to a wider patient population, rather than focusing only on patients located near investigative sites or treatment clinics. In addition, the Direct-to-Patient model increases the operational efficiency of studies, reducing the volume of wasted drug product and allowing for faster completion times with more reliable results.
5. Which clinical trials are appropriate for Direct-to-Patient?
The Direct-to-Patient model typically works best for trials involving patients that are immobile, unable to or not well enough to travel to sites for treatment. While there is some focus on geriatric and pediatric patients, as well as those with rare diseases, many therapeutic areas are being aided by Direct-to-Patient. It is also recommended for patients who have frequent or long visit requirements; those in remote locations and for studies that are quite lengthy or for chronic illnesses. Both investigational and commercial drug properties such as high value, strict temperature control, or strict stability parameters, personalized and life-saving medications, may also drive the need for Direct-to-Patient solutions. Direct-to-Patient needs also span across many therapeutic treatment areas.
6. What are the challenges and subsequent risks with a Direct-to-Patient model?
Varying country regulations based on global GDP guidance can present a variety of challenges for sponsors. Equally important, the Direct-to-Patient distribution model requires delivery and pick up within predetermined — and often tight — windows of time, not to mention absolute integrity in the cold chain. A single temperature excursion or delay in delivery can compromise patient visit schedules, impact their ability to remain enrolled in the study and potentially pose health risks. Often the initial dose will be administered at traditional healthcare facilities, such as investigator sites in trials or hospitals / clinics for commercial medications, and then this can be switched to a home care model thereafter, which often is a mix of traditional and home visits.
7. How is World Courier equipped to support Direct-to-Patient models?
World Courier is highly collaborative in setting up Direct-to-Patient projects of all shapes and sizes, from clinical to commercial, single country to multinational and from delivery of temperature controlled medication to patient homes to picking up patient specimens from residences to a combination of both. Often, there are multiple parties involved from sponsors or manufacturers, to CRO’s or other teams driving project or study requirements as well as pharmacies, laboratories. Homecare nursing companies are often a focal coordination and contact point for World Courier as nurses are visiting patient homes and scheduling visits that often require the delivery of medication, pickup of specimens or return medicines. The World Courier network is particularly advantageous in this regard as the collection and delivery locations can be spread across a wide geography. Every flight or extra step that can be avoided significantly reduces the risk to the product or delay in arrival. Detailed SOPs have been created to ensure compliance with the regulations, patient confidentiality and protocol or project support.
8. Does World Courier offer technologies that support Direct-to-Patient models?
World Courier, in conjunction with Cubixx Solutions, is proud to offer innovation solutions like Cubixx®CT, a small access-controlled refrigerator that stores drug products in the patient’s home. Medication can be stored at optimal 2 - 8 C temperatures and track usage. Plus, it eliminates the need for frequent deliveries where relevant and ensures the product is available when medical staff arrive to administer it. In addition, World Courier’s Bio-STAR system helps to proactively anticipate and prevent costly and common shipping issues shipping issues. An information management system designed to store and share all data necessary to undertake a shipment, Bio-STAR provides real-time access to detailed project or study instructions.
9. What experience does World Courier have with Direct-to-Patient?
World Courier has been supporting Direct-to-Patient trials for a number of years, however the demand for the service and patient-centric services overall has dramatically increased since 2014. Currently, World Courier handles hundreds of shipments weekly, supporting customers with Direct-to-Patient needs in most markets with a growth rate of over 100% from 2015-2016, and the growth has remained steadily in strong double digit percentages since. Our customers include traditional medium and large pharmaceutical companies, biotechnology organizations, CROs, CDMOs, homecare nursing companies, central laboratories and virtual science and technology companies.
10. What does the future hold for Direct-to-Patient models?
As the healthcare industry shifts to greater patient-centric approaches, the Direct-to-Patient model has become a growing trend. Once viewed as unrealistic due to safety and cost concerns, at-home clinical and commercial treatments applying a Direct-to-Patient approach are now viewed as viable and valuable.
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