January 22, 2014 Issue of JAMA

January 22/29, 2014, Vol 311, No. 4, Pages 327-435

This Week in JAMA

Highlights

Abstract Full Text

free access has audio

JAMA. 2014;311(4):327-329. doi:10.1001/jama.2013.279290

Podcast: Spotlight on FDA drug and device approval, microRNA biomarkers of pancreatic cancer, how to use a subgroup analysis, and more.

Original Investigation

Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

Nicholas S. Downing, AB; Jenerius A. Aminawung, MD, MPH; Nilay D. Shah, PhD; et al.

Abstract Full Text

free access has multimedia has audio

JAMA. 2014;311(4):368-377. doi:10.1001/jama.2013.282034

Podcast: Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012

Editorial
Opening the FDA Black Box
Steven N. Goodman, MD, MHS, PhD; Rita F. Redberg, MD, MSc

JAMA

Scientific and Regulatory Reasons for Delay and Denial of FDA Approval of Initial Applications for New Drugs, 2000-2012

Leonard V. Sacks, MBBCh; Hala H. Shamsuddin, MD; Yuliya I. Yasinskaya, MD; et al.

Abstract Full Text

free access

JAMA. 2014;311(4):378-384. doi:10.1001/jama.2013.282542

Sacks and coauthors identify the reasons that US Food and Drug Administration (FDA) marketing approval for new drugs was delayed or denied in drug applications for new molecular entities first submitted to the FDA between 2000 and 2012.

Editorial
Opening the FDA Black Box
Steven N. Goodman, MD, MHS, PhD; Rita F. Redberg, MD, MSc

JAMA

FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways, 1979-2012

Benjamin N. Rome, BA; Daniel B. Kramer, MD; Aaron S. Kesselheim, MD, JD, MPH

Abstract Full Text

free access

JAMA. 2014;311(4):385-391. doi:10.1001/jama.2013.284986

Using the US FDA鈥檚 premarket approval (PMA) database, Rome and coauthors analyzed the prevalence and characteristics of changes to cardiac implantable electronic devices made through the PMA supplement process. In an Editorial, Goodman and Redberg discuss how FDA policies of transparency can help balance innovation and protection of public health.

Editorial
Opening the FDA Black Box
Steven N. Goodman, MD, MHS, PhD; Rita F. Redberg, MD, MSc

JAMA

Preliminary Communication

MicroRNA Biomarkers in Whole Blood for Detection of Pancreatic Cancer

Nicolai A. Schultz, MD, PhD; Christian Dehlendorff, PhD; Benny V. Jensen, MD; et al.

Abstract Full Text

free access

JAMA. 2014;311(4):392-404. doi:10.1001/jama.2013.284664

Schultz and coauthors report preliminary data on microRNA biomarkers in whole blood for detection of pancreatic cancer. In an accompanying Editorial, Buchsbaum and Croce discuss whether detection of microRNA biomarkers in blood improve the diagnosis and survival of patients with pancreatic cancer.

Editorial
Will Detection of MicroRNA Biomarkers in Blood Improve the Diagnosis and Survival of Patients With Pancreatic Cancer?
Donald J. Buchsbaum, PhD; Carlo M. Croce, MD

JAMA

Research Letter

Association of Mediterranean Diet With Peripheral Artery Disease: The PREDIMED Randomized Trial

Miguel Ruiz-Canela, PhD; Ramón Estruch, MD, PhD; Dolores Corella, DPharm, PhD; et al.

Abstract Full Text

free access

JAMA. 2014;311(4):415-417. doi:10.1001/jama.2013.280618

This study examined the role of a Mediterranean diet in the prevention of peripheral artery disease (PAD) in a derivative analysis of the PREDIMED randomized clinical trial in adults older than 55 years with diabetes or cardiovascular risk factors.

Viewpoint