Benefit and Harms of New Anti-Cancer Drugs

Pathologic Complete Response Predicts Recurrence-Free Survival More Effectively by Cancer Subset: Results From the I-SPY 1 TRIAL—CALGB 150007/150012, ACRIN 6657

(2012) Laura J. Esserman et al.   JOURNAL OF CLINICAL ONCOLOGY

Pathological Complete Response and Accelerated Drug Approval in Early Breast Cancer

(2012) Tatiana M. Prowell et al.   NEW ENGLAND JOURNAL OF MEDICINE

Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer

(2011) Aaron S. Kesselheim   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Accelerated Approval of Oncology Products: The Food and Drug Administration Experience

(2011) John R. Johnson et al.   JNCI-Journal of the National Cancer Institute

New FDA Regulation to Improve Safety Reporting in Clinical Trials

(2011) Rachel Behrman Sherman et al.   NEW ENGLAND JOURNAL OF MEDICINE

Endpoints and surrogate endpoints in colorectal cancer: a review of recent developments

(2010) Pascal Piedbois et al.   CURRENT OPINION IN ONCOLOGY

Population-based differences in treatment outcome following anticancer drug therapies

(2010) Brigette BY Ma et al.   LANCET ONCOLOGY

What Constitutes Reasonable Evidence of Efficacy and Effectiveness to Guide Oncology Treatment Decisions?

(2010) D. Sargent   ONCOLOGIST

Adverse Events in Randomized Trials

(2009) John P. A. Ioannidis   ARCHIVES OF INTERNAL MEDICINE

Reporting of Safety Results in Published Reports of Randomized Controlled Trials

(2009)   ARCHIVES OF INTERNAL MEDICINE

Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?

(2009) Elizabeth A. Richey et al.   JOURNAL OF CLINICAL ONCOLOGY

Incremental Advance or Seismic Shift? The Need to Raise the Bar of Efficacy for Drug Approval

(2009) Alberto Sobrero et al.   JOURNAL OF CLINICAL ONCOLOGY

Adverse Event Detection in Drug Development: Recommendations and Obligations Beyond Phase 3

(2008) Jesse A. Berlin et al.   AMERICAN JOURNAL OF PUBLIC HEALTH

Inadequate statistical power to detect clinically significant differences in adverse event rates in randomized controlled trials

(2008) Ruth Tsang et al.   JOURNAL OF CLINICAL EPIDEMIOLOGY