Direct to Participant Investigational Product
Several strategies exist to bring studies closer to participants and reduce the number of visits a participant has to make to the study site. By sending the investigational product to the participant, visits to the site may be eliminated/reduced, however other logistical responsibilities may be assigned to the participant. Direct to participant investigational product may be an attractive strategy, depending on the study and study population.
Direct to participant approaches may increase burden on patients and sites and may not be appropriate for all study populations or study types. Participants may be identifiable to the 3rd party vendor and processes must be put into place to ensure vendors do not pass the participant information to the sponsor.
- Strategies and Opportunities
Ethics and Regulatory:
- Ensure compliance with provincial privacy regulations, as well as professional and regulatory requirements for health care providers (HCP).
- Understand supply chain and ensure end to end operational control (i.e., audit trail, cold chain if required, etc.).
Privacy and IT :
- Must have proper data security and privacy protections in place for information exchange with direct to participant supply chain.
- There are participant privacy considerations when receiving investigational product at their home address, and it must be ensured that the investigational product is being received by the intended recipient (i.e., the participant).
- Consider mechanisms for investigational product delivery including supply chain (e.g., site to participant, central pharmacy / depot to participant, site/central pharmacy to local neighbourhood pharmacy to participant, and direct to participant where participant maintains all investigational product in a home container/ fridge
- Supply chain elements, audit trails and accountabilities need to be clearly documented.
- Specialized 3rd party vendors should be used to support complicated logistics and identifiable participant information.
- Determine whether investigational product is amenable to direct to participant strategies e.g., stability, ready-to-use, requires re-constitution, method of administration).
- A healthcare provider (HCP) may be on site at the participant’s home to assist in the receipt of product.
- Development of detailed SOP’s for each step of direct to participant process are required, outlining accountabilities of each party, each supply chain step, receipt of delivery, use, storage, return of empty containers/unused product, role of site and site personnel etc.
Patient / Caregiver:
- Consider ease of operation for study participants in a direct to participant model, assessing the additional burdens for receipt, storage, administration, tracking, return of empty containers or unused product, etc.
- Consider participant satisfaction with direct-to-home delivery of investigational product.
- Consider the need for a HCP on-site at participants’ home to receive investigational product (chain of custody, administration, storage etc.).
- Consider ideal study participant types for direct to participant approaches (e.g., long study visits, frequent visits for investigational product administration/pick up, individuals with chronic illness, significantly ill, or those at considerable distances, etc.)
- Consider suitability for direct to participant in terms of ability to comply with requirements. There are significant logistical challenges in the event of temperature-controlled product.
- Delivery of product must be respectfully coordinated with the participant.
- Communication and supports are of utmost importance to ensure clear instruction and understanding. Video calls with a research staff at the time of delivery may be a beneficial support tool.
- Hybrid models involving pharmacies, local clinics and at-home visits can support this approach and increase choice to the participant.
- Coordinator can perform the reconciliation on the phone or video call.
- New technologies such as smart bottles can support direct to participant strategies.
- Participants may have to cross check information on the bill and ensure nothing was damaged.
- Participants may be given return/exchange kits to assist in accountability.
Opportunity to improve access to/uptake of decentralized approaches:
- Need clear guidance and regulations from Health Canada around direct to participant approaches.
- Implement standard language to CTO ICF template for studies using direct to participant strategies.
- Create a decision aid tool to inform decisions on direct to participant strategies.
- Clinical Trials Transformation Initiative, CITI Recommendations: Decentralized Clinical Trials 2018.dct_recommendations_final.pdf
- Legal, Regulatory, and Practical Issues to Consider When Adopting Decentralized Clinical Trials: Recommendations From the Clinical Trials Transformation Initiative.
- The Centricity of Decentralization. Allison Holland. Journal of Clinical Research Best Practices, Vol 16, 9, Sept 2020
- Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency: Guidance for Industry, Investigators and Institutional Review Boards. FDA https://www.fda.gov/media/136238/download
- Management of clinical trials during the COVID-19 pandemic: Notice to clinical trial sponsors
- Novartis direct to patient content