Patient-centricity has been a growing trend across the pharmaceutical and biotech industries for some time now. As the focus on precision and personalized medicine continues to increase, sponsors are looking for innovative ways to increase patient enrollment and compliance while reducing drug development timelines and costs. The direct-to-patient (DTP) model has emerged as a potential solution. This model illustrates a means by which a patient is able to receive his or her medication in the convenience of their home. In this blog we’ll share the top three challenges many sponsors face and how a direct-to-patient pharmacy can provide solutions.
Challenge 1: “I’m having difficulty recruiting patients that fit the disease profile and are located near the clinical sites.”
Identifying and enrolling patients, specifically for rare disease or orphan drug clinical trials, is certainly a challenge. In traditional clinical trial models, sponsors are often limited to recruiting patients located in close proximity to clinical sites. A direct-to-patient pharmacy solution alleviates this by expanding the recruitment parameters beyond clinical site locations since the agent can be dispensed and distributed to the patient’s home, even if located in a rural area. It also allows patients residing in remote areas increased access to clinical trials.
Challenge 2: “I am struggling with patient compliance.”
The average cost of enrolling one patient in a clinical trial can range anywhere from $15,700 to $26,000. If patients struggle to comply with the protocol it can cause the sponsor to incur unintended expenses and impact the clinical trial timeline. A DTP pharmacy can offer convenience and time-saving advantages to clinical trial participants to encourage compliance. It removes the costly burden of traveling long distances to the clinical site, which could be even more challenging for very sick patients. By enhancing the convenience factor for the patient, the sponsor also increases the likelihood of compliance.
Challenge 3: “I am running out of storage space at the clinical site.”
Managing supplies of an investigational agent in a clinical trial can present challenges. The typical practice is to ship inventory to the research pharmacy or the principal investigator’s office at a clinical site in anticipation of enrollment. One challenge is that the amount needed at study sites can only be estimated, and inadequate inventory may delay the study, while providing extra is expensive and wasteful. In the meantime, the pharmaceutical or drug product(s) and clinical supplies sit in storage until enrollment proceeds and dispensing begins. This ties up inventory and can create additional challenges with expiration dates and storage capacity. This is crucial when there is a complex manufacturing process which may result in limiting that inventory. However, there is an alternative model of clinical trial support for consideration.
Dispensing and shipping medication directly to patients from a licensed pharmacy eliminates the need for bulk shipments to be managed at the clinical site. This not only increases efficiency in transporting the drug product to the patient but also reduces the need for capital investments that may be needed for expanded storage capacity. At the center of every clinical trial or free goods program is a patient awaiting treatment. A direct-to-patient pharmacy solution can incorporate the elements needed to increase speed to market while also adapting patient-centricity. Contact us today to learn more about how we can help support your DTP needs.