Abstract

The US Food and Drug Administration has recently updated its website, Oncology Tools, and now provides selected materials in French, Japanese, and Arabic—with Chinese, Dutch, German, and Spanish to follow soon. The site brings together US regulatory information, a searchable database of approved (in the USA) oncology drugs, details on obtaining access (legally) to unapproved drugs, links to sites that provide information on specific cancers and clinical trials, and an array of interactive assessment tools. Highlights of the “approved oncology drugs” section—beyond the listing itself, which can be sorted by drug name, brand name, or manufacturer—include information on drugs to treat specific cancers, pediatric uses of drugs, and when to consider using unapproved therapies. The “regulatory tools” section features information on specific FDA cancer initiatives, an overview of FDA’s structure and responsibilities, information on institutional review boards, a dictionary of regulatory terms, a searchable archive of oncologic drugs advisory committee meetings, and requirements for filing applications for new and investigational drugs. Of interest in the “bioethics” area are various documents on human research protection, including such primary resources as the Helsinki Declaration and the 1979 Belmont Report on ethical principles. For clinicans, the “oncology reference tools” section is especially useful. Users can calculate drug dosages; assess caloric and fluid requirements; evaluate performance status using Karnofsky, ECOG/Zubrod, or Lansky scores; and check toxicity criteria using tables from the US National Cancer Institute, Southwestern Oncology Group, Radiation Therapy Oncology Group, and WHO. A disease staging manual is also available.

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