The Winter Imagine Forum Recap January 28, 2022 Signant Health Posted in Events Share: LinkedInTweet For Signant Health’s second Imagine Forum, we focused on how the industry can leverage direct-to-patient (DtP) clinical supply approaches to facilitate patient-centered, decentralized clinical trials. We’ve summarized the session’s key takeaways for you to apply to your next clinical trial. The Phases of DtP Maturity Signant Health’s Director of Product Positioning, Bart Nicholson, kicked off the webinar by establishing the various levels of DtP sophistication and integration. This framework gives sponsors a user-friendly mechanism to manage supplies while simultaneously establishing secure firewalls around the data. Level 1: Manual Coordination This level is used for those niche circumstances when a DtP model is urgently needed. Traditional supply chains (depot to clinical site) manually deliver supplies to patients by coordinating with logistical services. Unfortunately, this results in limited visibility for sites and sponsors. Level 2: Technology Enabled A fully digital chain of custody is achieved at this level. First, site staff enter the patients’ data into a central system, such as a RTSM solution, which takes care of the allocation and order generation. Shipment updates are electronically sent at every step for optimal visibility. Patients then confirm they received the clinical supplies using a provisioned or BYOD device. At this level, the investigator is also able to authorize dosing. Level 3: Integrated Enterprise Unlike the first two levels, DtP model is considered standard. Additional technology is leveraged to feed inventory and manufacturing data, enabling drug pooling and free-picking models to further increase supply chain efficiencies. Direct-to-Patient Challenges Marken’s VP of Commercial Operations, Julia Tarasenko, brought up three obstacles she’s experienced with DtP models. For one, there is some ambiguity around what defines a hybrid study. For one sponsor that could mean using a decentralized component to replace in-person site visits, while another may consider it the freedom for enrolled patients to choose between remote and in-person visits. In general, sponsors should design their study protocols with a certain level of flexibility to accommodate the various hybrid approaches as well as mid-study changes – the recent pandemic reinforces this need. “One of the greatest challenges on the logistics side is to build in the ability to have that flexibility,” Julia stressed. Additionally, the complex return and reconciliation process can be a pain point. It’s important to consider the process to ensure patients are not burdened. Julia also added that enrolled patients expect the same level of convenience in receiving clinical supplies as they do with online purchases. Therefore, there’s a growing demand for patient-centric, self-serve technology that works around the patient’s schedule and offers a seamless customer experience. When it comes to data privacy, Marcus Wajngarten, AstraZeneca’s Senior Director of Home Supply, argued, “Not only do we need to make sure that the right people see the right things when they need to see them, we need to make sure these records are managed after the study if consent is withdrawn.” Finally, it’s important to keep in mind the patient’s country of residence as there are regulations regarding how clinical supplies can be shipped. Benefits of Direct-to-Patient Supplies There are many reasons why DtP is such a hot topic within the industry. The use of technology in remote clinical studies often results in the following benefits: Reaching more diverse, eligible patients Improved retention Better engagement Integrate study requirements into daily life More convenience Optimize supplies Improve visibility Reduced burdens The Future of DtP While many sponsors have already implemented a DtP model, there is still much to be learned when leveraging technology in supply chain management. Sanofi’s International Distribution Expert, Marc Scotty, shared that his team is currently running a study to identify which delivery approach works best for patients and investigators. “The [patients] want to see the investigator in some way, but they don’t want to go each time,” Marc explained. To do this, Sanofi will be comparing a traditional site-based approach alongside a hybrid and a fully decentralized model. Regardless of how DtP evolves over time, the novel dedication to serving enrolled patients will remain the same. “Our job is to get the patient what they need – that can be a very diverse and complex need,” Marcus reinforced. Signant Health facebook twitter google-plus linkedin Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data quality analytics. 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For Signant Health’s second Imagine Forum, we focused on how the industry can leverage direct-to-patient (DtP) clinical supply approaches to facilitate patient-centered, decentralized clinical trials. We’ve summarized the session’s key takeaways for you to apply to your next clinical trial. The Phases of DtP Maturity Signant Health’s Director of Product Positioning, Bart Nicholson, kicked off the webinar by establishing the various levels of DtP sophistication and integration. This framework gives sponsors a user-friendly mechanism to manage supplies while simultaneously establishing secure firewalls around the data. Level 1: Manual Coordination This level is used for those niche circumstances when a DtP model is urgently needed. Traditional supply chains (depot to clinical site) manually deliver supplies to patients by coordinating with logistical services. Unfortunately, this results in limited visibility for sites and sponsors. Level 2: Technology Enabled A fully digital chain of custody is achieved at this level. First, site staff enter the patients’ data into a central system, such as a RTSM solution, which takes care of the allocation and order generation. Shipment updates are electronically sent at every step for optimal visibility. Patients then confirm they received the clinical supplies using a provisioned or BYOD device. At this level, the investigator is also able to authorize dosing. Level 3: Integrated Enterprise Unlike the first two levels, DtP model is considered standard. Additional technology is leveraged to feed inventory and manufacturing data, enabling drug pooling and free-picking models to further increase supply chain efficiencies. Direct-to-Patient Challenges Marken’s VP of Commercial Operations, Julia Tarasenko, brought up three obstacles she’s experienced with DtP models. For one, there is some ambiguity around what defines a hybrid study. For one sponsor that could mean using a decentralized component to replace in-person site visits, while another may consider it the freedom for enrolled patients to choose between remote and in-person visits. In general, sponsors should design their study protocols with a certain level of flexibility to accommodate the various hybrid approaches as well as mid-study changes – the recent pandemic reinforces this need. “One of the greatest challenges on the logistics side is to build in the ability to have that flexibility,” Julia stressed. Additionally, the complex return and reconciliation process can be a pain point. It’s important to consider the process to ensure patients are not burdened. Julia also added that enrolled patients expect the same level of convenience in receiving clinical supplies as they do with online purchases. Therefore, there’s a growing demand for patient-centric, self-serve technology that works around the patient’s schedule and offers a seamless customer experience. When it comes to data privacy, Marcus Wajngarten, AstraZeneca’s Senior Director of Home Supply, argued, “Not only do we need to make sure that the right people see the right things when they need to see them, we need to make sure these records are managed after the study if consent is withdrawn.” Finally, it’s important to keep in mind the patient’s country of residence as there are regulations regarding how clinical supplies can be shipped. Benefits of Direct-to-Patient Supplies There are many reasons why DtP is such a hot topic within the industry. The use of technology in remote clinical studies often results in the following benefits: Reaching more diverse, eligible patients Improved retention Better engagement Integrate study requirements into daily life More convenience Optimize supplies Improve visibility Reduced burdens The Future of DtP While many sponsors have already implemented a DtP model, there is still much to be learned when leveraging technology in supply chain management. Sanofi’s International Distribution Expert, Marc Scotty, shared that his team is currently running a study to identify which delivery approach works best for patients and investigators. “The [patients] want to see the investigator in some way, but they don’t want to go each time,” Marc explained. To do this, Sanofi will be comparing a traditional site-based approach alongside a hybrid and a fully decentralized model. Regardless of how DtP evolves over time, the novel dedication to serving enrolled patients will remain the same. “Our job is to get the patient what they need – that can be a very diverse and complex need,” Marcus reinforced. Signant Health facebook twitter google-plus linkedin Signant Health is the evidence generation company. We are focused on leveraging software, deep therapeutic and scientific knowledge, and operational expertise to consistently generate quality evidence for clinical studies across traditional, virtual, and hybrid trial models. For more than 20 years, over 400 sponsors and CROs of all sizes – including all of Top 20 pharma – have trusted Signant Health solutions for remote and site-based eCOA, eConsent, IRT, supply chain management, and data quality analytics.