Article: The Direct to Patient Model: Your Top 10 Q&A

By Mike Sweeney |

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.

2. What are the major differences between DtP and traditional clinical trials?

In the traditional clinical trial model, everything revolves around the investigational site. All relevant personnel — nurses, patients, research associates — 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 limited 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 DtP 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 DtP model benefit patients?

The DtP 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, can be reduced by more than half and the model is particularly advantageous for trials involving orphan diseases or paediatric patient populations.

4. How does a DtP model benefit trial sponsors?

The DtP model quells the two largest issues plaguing clinical trials: patient recruitment and retention. Because patients are assured of potentially significant time- and cost-savings when participating in DtP 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 DtP 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 DtP?

The DtP model typically works best for trials involving geriatric and pediatric patients, as well as those with rare diseases. It is also recommended for patients who have frequent or long visit requirements; those in remote locations where travel may be more difficult; and for studies that are quite lengthy or for chronic illnesses. Both investigational and commerical drug properties such as hgh value, temperature controlled, personalized and life-saving medications, may also drive the need for DtP solutions. DtP needs also span across many therapeutic treatment areas.

6. What are the challenges and subsequent risks with a DtP model?

Varying country regulations and GxP polices based on global GDP guidance can present a variety of challenges for sponsors. Equally important, the DtP 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 the entire study or the life of a patient. In studies where there is a risk of anaphylaxis or an adverse drug reaction with the initial dose, it is recommended to administer the initial, high-risk dose in the traditional healthcare facility, switching to a home care model thereafter.

7. How is World Courier equipped to support DtP models?

In 2015, World Courier entered into a partnership with the Medical Research Network (MRN) to create a more highly integrated model for community-based clinical trials. This collaboration combines the MRN’s expertise as an innovator in at-home clinical trials (servicing 38 countries and growing) with World Courier’s scale as the global leader in specialty logistics. This has enabled us to offer a unique Home Trial Support (HTS) service that makes study participation easier for patients to complete. It includes a fully qualified nurse who visits the patient in their home and performs all medically necessary trial protocols (infusion, collecting blood/urine samples). World Courier delivers/retrieves any related materials to the patient’s home and trial site. The World Courier network is particularly advantageous in this regard as the collection and delivery locations are often 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 support.

8. Does World Courier offer technologies that support DtP models?

World Courier, in conjunction with ASD healthcare, is proud to offer innovation solutions like Cubixx®CT, a small access-controlled refrigerator that stores drug products in the patient’s home. It can store medication at an optimal temperature, track its usage and provide reports to researchers. Plus, it eliminates the need for frequent deliveries where relevant and guarantees 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 shipping issues problems that are common when conducting studies. An information management system designed to store and share all data necessary to undertake a shipment, Bio-STAR provides real-time access to protocols and instructions and helps ensure all permits and supplies are in place.

9. What experience level does World Courier have in DtP models?

World Courier has been supporting DtP 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 DtP needs in most markets with a growth rate of over 100% from 2015-2016. Our customers include traditional Big Pharma companies, CROs, CDMOs clinical packaging service companies, central laboratories and small Biotech organisations.

10. What does the future hold for DtP models?

As the healthcare industry moves toward a more patient-centric approach while clinical trials expand in growing markets, the DtP model has become a growing trend. Once viewed as unrealistic due to quality and cost concerns, at-home clinical and commerical treatments applying a direct-to-patient approach are now viewed as viable and valuable.

For more information on the benefits of a direct to patient model, explore this suggested article.

About the Author

Portrait of Mike Sweeney

Mike Sweeney

Senior Director, Patient Centric Logistics
World Courier
Mike is responsible for the development and product management of World Courier’s specialty service offerings across 140 company-owned offices in 50+ countries, with focus on patient-centric areas such as Direct-to-Patient services. Since joining World Courier in 1992, Mike assumed a number of positions within US operations, customer service, training, compliance, marketing, sales and clinical trials management. He progressed to senior roles, including director of US customer service/operations, director of new service development and director of regional accounts, prior to transitioning into a global IT leadership position and most recently into his current role in 2015.
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