Optimizing Dosing of Oncology Drugs

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

(2014) Leonard V. Sacks et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

The Food and Drug Administration Amendments Act and Postmarketing Commitments

(2013) Kevin Fain et al.   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Toward Patient-Centered Drug Development in Oncology

(2013) Ethan Basch   NEW ENGLAND JOURNAL OF MEDICINE

U.S. Food and Drug Administration Approval: Ruxolitinib for the Treatment of Patients with Intermediate and High-Risk Myelofibrosis

(2012) A. Deisseroth et al.   CLINICAL CANCER RESEARCH

Maximum-Tolerated Dose, Optimum Biologic Dose, or Optimum Clinical Value: Dosing Determination of Cancer Therapies

(2012) John L. Marshall   JOURNAL OF CLINICAL ONCOLOGY

Reducing the toxicity of cancer therapy: recognizing needs, taking action

(2012) Charles S. Cleeland et al.   Nature Reviews Clinical Oncology

Use of Patient-Reported Outcomes to Improve the Predictive Accuracy of Clinician-Reported Adverse Events

(2011) E. Basch et al.   JNCI-Journal of the National Cancer Institute

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

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

Oversight of Fast-Track Drug Approval by FDA Stuck in Low Gear, Critics Say

(2010) Mike Mitka   JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION

Adverse Symptom Event Reporting by Patients vs Clinicians: Relationships With Clinical Outcomes

(2009) Ethan Basch et al.   JNCI-Journal of the National Cancer Institute

Dose Escalation Methods in Phase I Cancer Clinical Trials

(2009) Christophe Le Tourneau et al.   JNCI-Journal of the National Cancer Institute