The data file contains, among other details, sponsor, study ID, registration timing, and results reporting information for each of the 15 drugs included in our reanalysis of the following paper: Miller JE, Korn D, Ross JS. Clinical trial registration, reporting, publication and FDAAA compliance: a cross-sectional analysis and ranking of new drugs approved by the FDA in 2012. BMJ Open 2015; 5: e009758. doi:10. 1136/bmjopen-2015-009758. The data file also contains our compliance calculations and flags the differences, per trial, between our reanalysis and the findings of the original study
All FDA labels and extraction sheets to support our paper, Desai et al. "Reporting of drug benefit i...
Objectives: To describe the characteristics of clinical study report (CSR) documents published by th...
The Medical Review document of the FDA is a rich source of data about clinical trials underlying the...
Objective: To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open whi...
Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by...
OBJECTIVE: To examine compliance with mandatory reporting of summary clinical trial results (within ...
Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by...
This is the analyzable dataset for our BMJ paper evaluating data sharing and clinical trial transpar...
Table S1. Pivotal trials with at least one postapproval trial with a patient-relevant outcome. (XLSX...
Additional information for the Methods section. Details on how the trial results were categorized as...
Presenting the clinical trials supporting FDA approvals of drugs in cardiovascular disease and diabe...
BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of res...
Includes the clinical trial identifiers with publication status decisions sourced from three studies...
The United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submit...
Objectives To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in jo...
All FDA labels and extraction sheets to support our paper, Desai et al. "Reporting of drug benefit i...
Objectives: To describe the characteristics of clinical study report (CSR) documents published by th...
The Medical Review document of the FDA is a rich source of data about clinical trials underlying the...
Objective: To evaluate the accuracy of a 2015 cross-sectional analysis published in the BMJ Open whi...
Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by...
OBJECTIVE: To examine compliance with mandatory reporting of summary clinical trial results (within ...
Objective: To evaluate clinical trial registration, reporting and publication rates for new drugs by...
This is the analyzable dataset for our BMJ paper evaluating data sharing and clinical trial transpar...
Table S1. Pivotal trials with at least one postapproval trial with a patient-relevant outcome. (XLSX...
Additional information for the Methods section. Details on how the trial results were categorized as...
Presenting the clinical trials supporting FDA approvals of drugs in cardiovascular disease and diabe...
BACKGROUND: The Food and Drug Administration Amendments Act (FDAAA) mandates timely reporting of res...
Includes the clinical trial identifiers with publication status decisions sourced from three studies...
The United States (US) Food and Drug Administration (FDA) approves new drugs based on sponsor-submit...
Objectives To explore the effectiveness of data sharing by randomized controlled trials (RCTs) in jo...
All FDA labels and extraction sheets to support our paper, Desai et al. "Reporting of drug benefit i...
Objectives: To describe the characteristics of clinical study report (CSR) documents published by th...
The Medical Review document of the FDA is a rich source of data about clinical trials underlying the...