A potential resolution to a lingering debate on how the government should oversee laboratory-developed diagnostic tests would focus the FDA’s attention on the more cutting-edge and riskier screening tools. At issue is a disagreement between device companies and clinical laboratory groups on what constitutes appropriate federal oversight of laboratory-developed test (LDTs), which are developed in…
The American Society of Clinical Oncology proposed four ways to lower financial barriers that impede cancer patients’ ability to participate in clinical trials, including a recommendation to improve payer clinical trial coverage policies. According to a 2017 ASCO report, only 3% of cancer patients enter clinical trials. In a policy statement published Thursday, ASCO…
As Congress crafts new legislation on diagnostics to update a system first built in 1976, the US Food and Drug Administration (FDA) has offered feedback that will help to shape a modern framework whereby diagnostics can be relied on as accurate and safe, FDA Commissioner Scott Gottlieb said in a speech Thursday to the Friends…
A negative coverage recommendation proposed by the Oregon Health Authority could restrict access to next-generation sequencing tumor profiling for some of the most vulnerable residents in the state, cancer patient advocates fear. In June, the health authority’s Health Evidence Review Commission (HERC) issued a draft guidance strongly recommending against covering NGS testing of solid…
Executive Summary Recent draft guidance documents address adolescent enrollment in adult cancer trials, use of cohort designs in early-phase studies, and inclusion of placebo controls; more advice is coming soon on master protocols, adaptive designs and novel endpoints, FDA’s Gottlieb says. The US FDA is using its guidance-writing powers to reshape the look of…
Executive Summary One of the hallmarks of the “breakthrough” era has been the rapid expansion of first-in-human trials into pivotal studies for efficacy submissions. In a new draft guidance, FDA offers some initial thoughts on safeguards to make hyperfast development pathways successful. A US FDA draft guidance on expansion cohorts serves as a “starting…
Executive Summary The American Clinical Laboratory Association (ACLA) split with other stakeholder groups in criticizing US FDA’s proposals for a new diagnostics regulatory regime. ACLA asked Congress to stay closer to Reps. Diana DeGette’s and Larry Bucshon’s original Diagnostics Accuracy and Innovation Act draft bill language. Makers of test kits, represented by AdvaMedDx, and at…
Executive Summary Death typically is not included in electronic health records, and sources are disparate; Difficulties with endpoint expose potential limitation to real-world evidence use. Death, likely among the easiest real-world data points to measure, is proving among the more difficult to gather, illustrating that while real-world data holds great promise, there still are…
In a Friends of Cancer Research (Friends) meeting devoted to real-world evidence, members of the cancer community generally agreed that its use has an increasingly important role to play in gathering the data necessary to test, evaluate, and bring new therapeutic agents to market. This Friends meeting, which was titled “The Future Use of Real-World…
Clinical trials are the cornerstone of oncology research. Despite their essential role in evidence-based medicine, enrollment barriers are more formidable than ever. Limited study availability at some academic and community centers, as well as lack of provider recommendation, largely explain why fewer than one in 20 patients with cancer participate in clinical trials. …
