Deliver Direct-to-Participant

Opportunity

It is important to consider how study participants receive their study medication, to minimize impact to their time / effort and to align with a move towards decentralization of clinical trials. The provision of study medication could be achieved through direct-to-participant (otherwise known as direct-to-patient (DtP)) shipping, which includes depot-to-patient, pharmacy-to-patient, clinical site-to-patient, or by shipping to a local pharmacy or clinic for collection.

Considerations to Help Action the Opportunity

• Understand patients’ preference and capabilities for receipt of study medication (i.e., shipment to home vs collection from local clinic / pharmacy)
• Develop training and documentation to facilitate participant / care partner(s) use and confident compliance; emphasize site contacts or other contacts for questions or support
• Understand whether the study medication is appropriate for at home administration / storage; detailed risk assessment may be appropriate
• Understand the distribution models in each country to manage the full chain of custody that satisfies regulatory and privacy requirements, given that these requirements for DtP are generally country-specific 
• Partner with sites to support acceptance of study medication transport from site pharmacy, or depot, and according to site processes
• Understand site challenges / concerns associated with third-party and participant oversight and their ability to maintain study drug oversight
• Understand the requirements of the site pharmacy, depot or local clinic / pharmacy to prepare study medication for transport, at home storage and use
• Define appropriate storage facilities and controls to maintain stability, prevent temperature excursions or unauthorized use at participants’ home
• Define how unused medication will be returned and the systems and processes needed to manage accountability and compliance (e.g., IXRS, EDC)
• Develop medication compliance measures to accommodate for the change in oversight
• Partner with vendors to cover critical services needed to address study medication stability and confirmation of delivery to participant is obtained
• Evaluate shipping vendors qualifications for study medicine shipment, as per local requirements for dispensing and cross-border / state transport

Value and Potential Benefits

• Helps to improve patient recruitment and retention by reducing the number of in clinic visits (e.g., to collect and / or re-supply study medication) and subsequent impact on participants daily life, potentially leading to increased participant interest to join a clinical trial