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Applied Clinical Trials
Q&A explores the evolution of community-based studies-and the related sample management, regulatory, compliance, and logistics support considerations.
Recently, the direct-to-patient (DTP) model, which brings certain medical procedures and protocols to a patient’s home, has emerged as a popular solution. In 2015, the Medical Research Network (MRN), a provider of home healthcare for patients in clinical trials, entered a partnership with World Courier, a global specialty logistics company and a part of AmerisourceBergen, to elevate the reach and effectiveness of DTP clinical trials. The partnership’s aim is to increase patient recruitment and
retention and provide an integrated supply chain in the transportation of patient samples and the storage and distribution of investigational medicinal products (IMPs).
In the following Q&A, Michael Sweeney, senior director of global service development at World Courier, and Stuart Redding, vice president of global business development and marketing at MRN, share insights on the evolution of community-based trials.
Q: How does the DTP model improve the recruitment and retention of qualified patients?
REDDING: As clinical trials continue to grow more complex, patient recruitment and retention will remain a major challenge that sponsors face. Today’s protocols are more demanding than ever and frequent travel to a clinical site can deter patients from long-term participation in studies, especially when the site is far from their homes. In fact, about 25% of patients drop out before study completion.
In many studies, as many as 50% of the visits could be relocated to a patient’s home. The added convenience is a critical factor in retaining patients, who otherwise might have to regularly travel to a clinical trial site for procedures, such as IMP administration, that can take hours to complete.
Q: How do organizations ensure the clinical products are safely transported in a timely manner?
SWEENEY: When more home visits are incorporated into trials, nurses or courier drivers may travel long distances to a patient’s home. Some trips require flights, while others call for long drives to remote areas. In order to reduce the number of deliveries, we are in the process of deploying small, temperature- and access-controlled refrigerators in patients’ homes. The solution stores medication securely and at an optimal temperature, providing in-home access to the product. It features a real-time remote temperature monitoring system as well as security features and inventory management capabilities that to track product access. We’ve found that such in-home solutions help improve patient adherence and reduce medication waste.
REDDING: Every home visit requires a coordinated approach from all stakeholders-which includes nurses, the pharmacy, the logistics company, the site and the central lab-to ensure IMP is delivered from the pharmacy to the patient’s home on time, at the appropriate temperature and in the perfect condition, no matter the distance.
When planning the home visits, the entities must understand the temperature control and monitoring needs of the product being delivered, identify an appropriate packaging solution and outline the specific timing. Given all the potential variables, flexibility is critical to our success. That’s why we develop detailed contingency plans for all studies to ensure we are prepared to overcome any unforeseen obstacles.
Q: Varying country regulations, compliance with GxP policies and global logistics support are often the main challenges associated with the DTP model. How can sponsors overcome those hurdles?
REDDING: Perhaps the most important step is partnering with a home trial company early in the process, in order to maximize the number of home visits and gain insight into the regulatory landscape. Such companies that bring an in-depth knowledge of the countries they operate in can help ensure adherence to both good clinical practice standards and local market regulations. It’s critical for sites to be well-educated in the homecare service as well. For example, they need to understand who is seeing their patients, how their source data will be provided and what their responsibility is to maintain oversight of the patient’s progress.
SWEENEY: Partnering with a specialty logistics company that has an understanding of the requirements and a local presence in the market can be extremely helpful for sponsors, especially smaller biotechnology firms that may have limited resources or exposure to a country’s regulatory environment. Regulatory requirements and import procedures related to clinical trial products vary from country to country and are subject to change. Through integrated, GxP-compliant supply chain solutions, specialty logistics partners can meet the quality requirements and ensure the integrity of products and chain of custody.