Details

Autor(en) / Beteiligte

• Pinheiro, Simone P., ScD, MSc
• Rivera, Donna R., PharmD, MSc
• Graham, David J., MD, MPH
• Freedman, Andrew N., PhD
• Major, Jacqueline M., PhD, MS
• Penberthy, Lynne, MD, PhD
• Levenson, Mark, PhD
• Bradley, Marie C., PhD, MPH, MPharm
• Wong, Hui-Lee, PhD, MSc
• Ouellet-Hellstrom, Rita, PhD, MPH

Titel

Challenges in evaluating cancer as a clinical outcome in postapproval studies of drug safety

Ist Teil von

• Annals of epidemiology, 2016-11, Vol.26 (11), p.735-740

Ort / Verlag

United States: Elsevier Inc

Erscheinungsjahr

2016

Quelle

Elsevier ScienceDirect Journals

Beschreibungen/Notizen

• Abstract Pharmaceuticals approved in the United States are largely not known human carcinogens. However, cancer signals associated with pharmaceuticals may be hypothesized or arise after product approval. There are many study designs that can be used to evaluate cancer as an outcome in the postapproval setting. Because prospective systematic collection of cancer outcomes from a large number of individuals may be lengthy, expensive, and challenging, leveraging data from large existing databases are an integral approach. Such studies have the capability to evaluate the clinical experience of a large number of individuals, yet there are unique methodological challenges involved in their use to evaluate cancer outcomes. To discuss methodological challenges and potential solutions, the Food and Drug Administration and the National Cancer Institute convened a two-day public meeting in 2014. This commentary summarizes the most salient issues discussed at the meeting.