Healthcare
Local Test/ing in Clinical Trials Working Group
Advancing good practices and future approaches for use of local test options in clinical trials
Today, oncology clinical trials aim to deliver cutting-edge treatments and high-quality outcomes for patients while being as operationally efficient and effective as possible. Trial sponsors, together with site investigator partners, are increasingly interested in using pre-existing local test results from a patient’s medical record and/or biomarker testing by local laboratories during a trial to enroll patients. This may occur in parallel to central testing and the development of a companion diagnostic assay for simultaneous regulatory submissions for the drug and device. Use of pre-existing results or local testing can promote faster test turnaround times and availability of samples for testing, thus enabling timelier access to trials for more patients and faster overall trial progress to expedite development for promising treatments. That said, using either test option—pre-existing results or local testing—can present complexities for a trial’s implementation and regulatory approval of the treatment.
Against this backdrop, a select group of industry leaders are collaboratively seeking to address the use of local test options in trials. Specifically, the Local Test/ing in Clinical Trials Working Group will:
- Create a collaborative platform to identify and share good practices in using a local test option in oncology clinical trials to support the overarching goal of increasing patient access to investigational therapies
- Provide a trial sponsor view on the effective, pragmatic use of a local test option in oncology clinical trials to inform future thinking for regulators, the laboratory community, and other stakeholders
Amgen, AstraZeneca, Eli Lilly, and Gilead Sciences are sponsors of this initiative. This effort will collaborate with the Medical Device Innovation Consortium’s Somatic Reference Sample effort, Friends of Cancer Research, and other stakeholders in diagnostics and drug development to elicit diverse views on these topics. Tapestry will provide staff support and a platform to advance this initiative in 2025.
