No more than 5 percent of cancer patients enroll in clinical trials. Many patient advocates say restrictive eligibility criteria prevent people who want to be part of research from participating. On Aug. 9, the American Society of Clinical Oncology and Friends of Cancer Research submitted draft guidance documents to the U.S. Food and Drug Administration…
FDA issued draft guidance Friday (Aug. 10) intended to help streamline the drug development process for cancer drugs and biological products by providing sponsors with advice on how they can design and conduct seamless clinical trials, which allow drug developers to conduct one continuous trial and avoid the stops and starts associated with traditional three-phase…
Following years of debate on the issue, FDA is floating a legislative proposal that would cement the agency’s authority to regulate high-risk clinical laboratory diagnostics – including laboratory-developed tests and in-vitro diagnostics – under a risk-based framework in which lower-risk tests could go through FDA’s new, voluntary precertification pathway. The plan drew praise from device…
Representatives of the device industry praised FDA for expanding on concepts included in a diagnostic test oversight bill floating on Capitol Hill, such as creating efficient, predictable pathways to market for diagnostic tests; accrediting third-party organizations to help with the review process; and recognizing the effect of special controls, which exempt certain in vitro clinical…
ASCO and Friends of Cancer Research (Friends) have submitted recommended language to the U.S. Food and Drug Administration (FDA) for five guidance documents on ways to broaden eligibility criteria for cancer clinical trials. The recommendations are part of an ASCO and Friends collaboration to broaden eligibility for participating in clinical trials by addressing five specific…
The American Society of Clinical Oncology and Friends of Cancer Research have submitted recommended language to the Food and Drug Administration for ways to expand eligibility criteria for cancer clinical trials. The recommendations address five specific areas that were identified as most likely to restrict participation, but least likely to affect the safety of…
Groups ask FDA to issue five guidance documents to increase clinical trial eligibility for cancer patients Trials could open to patients with HIV, spread of brain cancer, teenagers New cancer therapies could reach patients more quickly under a proposal by two cancer groups to increase access to the clinical trials that are essential for…
The American Society of Clinical Oncology (ASCO) and Friends of Cancer Research have drafted five US Food and Drug Administration (FDA) guidance documents focusing on cancer clinical trial eligibility criteria for patients with brain metastases, HIV/AIDS, organ dysfunction, prior and concurrent malignancies and minimum age for enrollment. The 30 pages worth of recommendations “aim…
Executive Summary CDER Director Woodcock says for regulatory purposes, using real-world data likely will remain a case-by-case decision. The US FDA does not appear ready to add indications to drug labels solely based on real-world evidence, even if the correlations to clinical trial data are strong, but still wants the experiments to be done.…
Health-care legislation may take a back seat in Congress as Trump’s pick for the Supreme Court and must-pass spending bills will dominate the debate on Capitol Hill. The House has already left for a month-long summer break; the Senate is off the week of Aug. 6 but otherwise is in session. Congress will have…
