Informing the Tolerability of Cancer Treatments Using Patient-Reported Outcome Measures: Summary of an FDA and Critical Path Institute Workshop.

The US Food and Drug Administration and the Critical Path Institute's Patient-Reported Outcome (PRO) Consortium convened a cosponsored workshop on the use of PRO measures to inform the assessment of safety and tolerability in cancer clinical trials. A broad array of international stakeholders involved in oncology drug development and PRO measurement science provided perspectives on the role of PRO measures to provide complementary clinical data on the symptomatic side effects of anticancer agents. Speakers and panelists explored the utility of information derived from existing and emerging PRO measures, focusing on the PRO version of the National Cancer Institute's Common Terminology Criteria for Adverse Events.

Gastric adenocarcinoma: the role of Helicobacter pylori in pathogenesis and prevention efforts.

Gastric cancer is the third most common cause of cancer deaths in the world, prompting high-risk countries like South Korea and Japan to establish nationwide screening programmes. Helicobacter pylori is linked to the majority of gastric adenocarcinoma cases and to the vast majority of non-cardia gastric adenocarcinomas. Several studies have demonstrated the effectiveness of 'test-and-treat' programmes for H.

Managing Helicobacter pylori in college health, with special considerations for international students.

Objective: Helicobacter pylori infection is the major cause of dyspepsia, peptic ulcer disease, and gastric cancer. This paper will make specific recommendations for a diagnostic and treatment strategy tailored to the international student population.

Participants/methods: This paper is a case report and narrative review based on recent international epidemiologic studies and consensus conference recommendations identified in MEDLINE.