The U.S. Food and Drug Administration (FDA) has released a guidance, effective immediately, allowing for an Institutional Review Board (IRB) to waive informed consent requirements for clinical investigations that include adequate protections for human subjects and present a minimal risk.
ASCO in Action regularly provides the latest news and analysis related to cancer policy news; see the following online articles. These updates provide snapshots of ASCO’s ongoing advocacy efforts, as well as opportunities for ASCO members and guests to take action on critical issues affecting the cancer community.
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The nonprofit Reagan-Udall Foundation for the Food and Drug Administration has released a new, online resource called the Expanded Access Navigator. The website, which focuses on oncology with plans to expand to other disease areas, features the first pharmaceutical company directory of expanded access policies and criteria, as well as educational resources, guides and downloadable forms. ASCO was one of several organizations to help develop the Navigator.
ASCO and Friends of Cancer Research (Friends) held a meeting on June 30 with key stakeholders across the cancer research community to identify concrete approaches to broaden eligibility criteria for cancer clinical trials.
ASCO joined more than 35 other organizations, including professional societies, patient advocacy groups, and research institutions, to encourage the U.S. Food and Drug Administration (FDA) to develop a guidance on plain language summaries for clinical trials results.
The National Institutes of Health (NIH) recently announced the Next Generation Researcher Initiative, which is designed to increase funding to early-stage and mid-career researchers.
ASCO's Targeted Agent and Profiling Utilization Registry (TAPUR) Study continues to expand and now has more than 300 participants enrolled on study drug, more than 100 sites, new partnerships, and a revised protocol to lower the age of eligibility.
ASCO has released findings from an ASCO-National Cancer Institute (NCI) collaboration that explored centralizing the development of coverage analyses for multi-site cancer clinical trials. In an ASCO special article published May 8 in the Journal of Oncology Practice, “Feasibility of a Centralized Clinical Trials Coverage Analysis: A Joint Initiative of the American Society of Clinical Oncology and the National Cancer Institute,” the authors assert that developing a centralized system for coverage analysis is a feasible way to address key issues and reduce administrative burdens for cancer research sites managing billing compliance, with potential for widespread benefits across the cancer research field.
On April 1, Jack F. Whelan, a member of the CancerLinQ® Patient Advisory Committee, received an award from the American Association for Cancer Research for his history of advocacy on behalf of patients with cancer and their family and friends.
On March 8, ASCO held a workshop on streamlining adverse events (AE) reporting for cancer clinical trials. Led by ASCO Past President Julie M. Vose, MD, MBA, FASCO, and ASCO President Daniel F. Hayes, MD, FACP, FASCO, the workshop focused on developing a roadmap for making AE reporting as meaningful and informative as possible and overcoming current issues with the reporting process.
ASCO has submitted comments to the National Institutes of Health (NIH) in response to a Request for Information (RFI) on data sharing and management (NOT-OD-17-015).