Single pivotal trials with few corroborating characteristics were used for FDA approval of cancer therapies.

[1]  L. Trinquart,et al.  Design analysis indicates Potential overestimation of treatment effects in randomized controlled trials supporting Food and Drug Administration cancer drug approvals. , 2018, Journal of clinical epidemiology.

[2]  J. Ioannidis,et al.  The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs , 2018, Trials.

[3]  L. Hemkens,et al.  How to use FDA drug approval documents for evidence syntheses , 2018, British Medical Journal.

[4]  A. V. Morant,et al.  European Marketing Authorizations Granted Based on a Single Pivotal Clinical Trial: The Rule or the Exception? , 2018, Clinical pharmacology and therapeutics.

[5]  Arnoud J Templeton,et al.  Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration , 2018, Journal of the National Cancer Institute.

[6]  Fares Alahdab,et al.  Treatment Effect in Earlier Trials of Patients With Chronic Medical Conditions: A Meta‐Epidemiologic Study , 2018, Mayo Clinic proceedings.

[7]  A. Krist "Needs More Research"-Implications of the Proteus Effect for Researchers and Evidence Adopters. , 2018, Mayo Clinic proceedings.

[8]  Joyce Cheng Inference Based on Small Randomized Oncology Clinical Trials: Is the Observed Treatment Effect True? , 2017 .

[9]  J. Ioannidis,et al.  Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval , 2017, The Milbank quarterly.

[10]  J. Ioannidis,et al.  Sex based subgroup differences in randomized controlled trials: empirical evidence from Cochrane meta-analyses , 2016, British Medical Journal.

[11]  P. Peyton,et al.  Poor agreement in significant findings between meta-analyses and subsequent large randomized trials in perioperative medicine. , 2016, British journal of anaesthesia.

[12]  Harlan M. Krumholz,et al.  Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012. , 2014, JAMA.

[13]  Christopher W. Jones,et al.  Non-publication of large randomized clinical trials: cross sectional analysis , 2013, BMJ.

[14]  L. Trinquart,et al.  Influence of trial sample size on treatment effect estimates: meta-epidemiological study , 2013, BMJ : British Medical Journal.

[15]  Rebecca M. Turner,et al.  The Impact of Study Size on Meta-analyses: Examination of Underpowered Studies in Cochrane Reviews , 2013, PloS one.

[16]  K. Getz,et al.  Oncology drug development and approval of systemic anticancer therapy by the U.S. Food and Drug Administration. , 2013, The oncologist.

[17]  John P A Ioannidis,et al.  Empirical evaluation of very large treatment effects of medical interventions. , 2012, JAMA.

[18]  Gordon H Guyatt,et al.  Credibility of claims of subgroup effects in randomised controlled trials: systematic review , 2012, BMJ : British Medical Journal.

[19]  J. Ioannidis,et al.  Recommendations for examining and interpreting funnel plot asymmetry in meta-analyses of randomised controlled trials , 2011, BMJ : British Medical Journal.

[20]  Isabelle Boutron,et al.  Single-Center Trials Show Larger Treatment Effects Than Multicenter Trials: Evidence From a Meta-epidemiologic Study , 2011, Annals of Internal Medicine.

[21]  C. Mullins,et al.  Uncertainty in assessing value of oncology treatments. , 2010, The oncologist.

[22]  P. Keegan,et al.  Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007. , 2010, Journal of the National Cancer Institute.

[23]  J. Ioannidis Why Most Discovered True Associations Are Inflated , 2008, Epidemiology.

[24]  Ross J. Harris,et al.  Correction: reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. , 2008, Annals of internal medicine.

[25]  R. Temple How FDA currently makes decisions on clinical studies , 2005, Clinical Trials.

[26]  Zhenming Shun,et al.  Statistical consideration of the strategy for demonstrating clinical evidence of effectiveness—one larger vs two smaller pivotal studies , 2005 .

[27]  Sara T Brookes,et al.  Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. , 2004, Journal of clinical epidemiology.

[28]  Christian Gluud,et al.  Reported Methodologic Quality and Discrepancies between Large and Small Randomized Trials in Meta-Analyses , 2001, Annals of Internal Medicine.

[29]  P. Myles,et al.  Why we need large randomized studies in anaesthesia. , 1999, British journal of anaesthesia.

[30]  L. Fisher One Large, Well-Designed, Multicenter Study as an Alternative to the Usual Fda Paradigm , 1999 .

[31]  J. Ioannidis,et al.  Issues in comparisons between meta-analyses and large trials. , 1998, JAMA.

[32]  G. Grégoire,et al.  Discrepancies between meta-analyses and subsequent large randomized, controlled trials. , 1997, The New England journal of medicine.