Lightship has developed an operational model for oncology trials that includes the benefits of home visits and locations closer to patients while ensuring appropriate safety monitoring and support.
This approach provides greater convenience to patients, as it provides more access to people not living near a site and for those who find travel challenging.
The operating model for this approach also allows the flexibility for investigators to see patients in the clinic for their ongoing care or research visits.
In its meeting with the FDA's Digital Health Technologies Steering Committee on February 10, 2023, the FDA provided feedback on various aspects of Lightship's approach to oncology clinical trial design and delivery.
This engagement serves to support oncology clinical trials, which are designed to offer more access and choice for people living with cancer to take part in clinical trials.
Lightship said it plans to build upon this review process and continue to engage with the FDA and other stakeholders on approaches to support more inclusive clinical trials and improve health equity for all.
Lightship is a clinical trials service provider focused on increasing access and choice in taking part in research to improve equity for all.
The company designs and conducts studies in partnership with biopharmaceutical companies to accelerate bringing new therapies to market.
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