When COVID-19 initially appeared in China, clinical trial teams experienced tremendous disruption. With limited time to prepare, sites and depots struggled to keep regular dispensing schedules.
Historically, the Chinese New Year produced modest delays of a few weeks, but during the pandemic, it took more than 12 weeks to return to acceptable on-time dispensing levels.
Other regions did better. Sponsors who had previously adopted Direct-to-Participant (DtP) distribution techniques maintained consistency, ensuring participants received their medications even when site visits were unavailable.
DtP: More than a crisis response – a wiser approach to execute trials
While DtP shipments were helpful during the pandemic, their true value lies in efficiency, flexibility, and participant-centricity. By enabling medication delivery straight to participants' homes, sponsors can:
- Reduce site burden
- Minimize missed visits
- Improve participant retention
- Increase timelines
This strategy is not just useful in crises; it is also a scalable answer for modern trials.
Key considerations for implementing DtP shipments
Regulatory compliance
Sponsors must understand country-specific rules to verify that DtP is legal and carried out effectively. The key questions include:
- Can participants receive treatment at home under local laws?
- Who is allowed to dispense medications?
- Does the protocol require specific documentation and informed consent?
Participant privacy and data protection
Maintaining participant confidentiality is crucial. Sponsors must:
- Share participant information with couriers without disclosing it to the sponsor.
- Prohibit dissemination of health data.
- Ensure trial participants' confidentiality.
Operational best practices
To streamline DtP installation, sponsors should:
- Update protocols to support DtP as a safety and efficiency measure.
- Update informed consent forms to incorporate shipment information and data protection agreements.
- Use IRT systems to control dispensing, trace shipments, and ensure accountability.
Perceptive IRT/RTSM: Enabling seamless DtP shipments
Perceptive IRT/RTSM supports both site-to-participant and depot-to-participant models, providing flexibility according to study requirements.
Site-to-participant shipping
- Investigator uses IRT as usual.
- Courier gathers and distributes kits to participants.
- Delivery confirmation is documented in the eCRF.
- Recommend: Increasing pack life to account for transit time.
Depot-to-participant shipments
- The investigator assigns kits from the depot's reserved stock.
- Depot arranges courier delivery.
- Site is notified after successful delivery.
- Kits are tracked and reconciled using IRT.
Automation and integration: Making DtP effortless
Perceptive IRT/RTSM streamlines DtP logistics with:
- Stock Reservation: Depots can reserve goods for certain locations.
- Automated Notifications: Real-time alerts ensure site and depot alignment.
- Proof of Delivery: Couriers can update delivery status in IRT or through system integration.
- eCRF Integration: Ensures reliable tracking and reporting.
Conclusion: Future-proofing trials using DtP
Direct-to-Patient shipments are no longer just a backup plan; they are a strategic advantage. By incorporating DtP into trial design from the start, sponsors can improve operational efficiency, improve participant experience, and lower risk.
Perceptive's IRT/RTSM experts are ready to assist you in implementing effective DtP solutions, whether you are responding to an interruption or proactively simplifying your study.
About Perceptive
For over 30 years, Perceptive eClinical has been a pioneer in RTSM, building and supporting thousands of studies of all designs, from all therapeutic areas and across all phases.
With industry-leading experts delivering flexible, right-fit solutions to accelerate your trial and safeguard your data, we’re more than just an RTSM provider - we are your ally, in streamlining clinical trials, improving data accuracy, and enhancing participant experience. We help make trials more efficient, reduce costs, and accelerate time to market.
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