Sharing Clinical Trial Data

A Coefficient of Agreement for Nominal Scales

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Data Sharing by Scientists: Practices and Perceptions

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Resolving Individuals Contributing Trace Amounts of DNA to Highly Complex Mixtures Using High-Density SNP Genotyping Microarrays

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Ten Simple Rules for Reproducible Computational Research

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Outcome Reporting in Industry-Sponsored Trials of Gabapentin for Off-Label Use

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NIH clinical trials and publication bias.

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Protecting Communities in Biomedical Research

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From patients to partners: participant-centric initiatives in biomedical research

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Suicidal Thoughts and Behavior With Antidepressant Treatment

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Evaluating re-identification risks with respect to the HIPAA privacy rule

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Big Data’s End Run around Anonymity and Consent

2014 • 273 citations

ARTICLE 29 Data Protection Working Party

2013 • 268 citations

SPIRIT 2013: new guidance for content of clinical trial protocols

2013 • 267 citations

Informing Study Participants of Research Results: An Ethical Imperative

2003 • 265 citations

How (not) to protect genomic data privacy in a distributed network: using trail re-identification to evaluate and design anonymity protection systems

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Again, and Again, and Again …

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Sharing research data to improve public health

2011 • 238 citations

Cardiovascular events associated with rofecoxib: final analysis of the APPROVe trial

2008 • 234 citations

Data Monitoring Committees in Clinical Trials: A Practical Perspective

2002 • 233 citations

Countering GATTACA

2011 • 229 citations

Validation of 6-Minute Walk Distance as a Surrogate End Point in Pulmonary Arterial Hypertension Trials

2012 • 229 citations

Guidance Regarding Methods for De-identification of Protected Health Information in Accordance with the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule

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Is Deidentification Sufficient to Protect Health Privacy in Research?

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Learning your identity and disease from research papers

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Identifying Participants in the Personal Genome Project by Name

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Restoring invisible and abandoned trials: a call for people to publish the findings

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Reporting Mortality Findings in Trials of Rofecoxib for Alzheimer Disease or Cognitive Impairment

2008 • 178 citations

The Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience

2012 • 170 citations

Clinical trial registration: transparency is the watchword

2006 • 164 citations

Preparing for Responsible Sharing of Clinical Trial Data

2013 • 163 citations

Beyond the HIPAA Privacy Rule: Enhancing Privacy, Improving Health Through Research

2009 • 157 citations

Fate of biomedical research protocols and publication bias in France: retrospective cohort study

2005 • 155 citations

From consent to institutions: Designing adaptive governance for genomic biobanks

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The FDA's Critique of the Anturane Reinfarction Trial

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Race and Sex Differences in Response to Endothelin Receptor Antagonists for Pulmonary Arterial Hypertension

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The randomized clinical trial: bias in analysis.

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A Cryptographic Approach to Securely Share and Query Genomic Sequences

2008 • 148 citations

Belmont revisited : ethical principles for research with human subjects

2005 • 140 citations

Sharing Publication-Related Data and Materials: Responsibilities of Authorship in the Life Sciences

2003 • 140 citations

The disclosure of diagnosis codes can breach research participants' privacy

2010 • 137 citations

Science as a public enterprise: the case for open data

2011 • 134 citations

Why we need easy access to all data from all clinical trials and how to accomplish it

2011 • 133 citations

Anonymization of electronic medical records for validating genome-wide association studies

2010 • 132 citations

A human rights approach to an international code of conduct for genomic and clinical data sharing

2014 • 132 citations

Addressing the concerns of the lacks family

2013 • 128 citations

Publication Bias and Research on Passive Smoking

1998 • 126 citations

Sharing and Reporting the Results of Clinical Trials

2014 • 126 citations

The Abandoned Trials of Pre-Exposure Prophylaxis for HIV: What Went Wrong?

2005 • 124 citations

An Improved Approach To Measuring Drug Innovation Finds Steady Rates Of First-In-Class Pharmaceuticals, 1987–2011

2013 • 124 citations

Access to Patient-Level Data from GlaxoSmithKline Clinical Trials

2013 • 120 citations

Sharing of clinical trial data among trialists: a cross sectional survey

2012 • 120 citations

Views of US researchers about informed consent in international collaborative research

2005 • 117 citations

Protecting and evaluating genomic privacy in medical tests and personalized medicine

2013 • 117 citations

Antidepressants and Pediatric Depression — The Risk of Doing Nothing

2004 • 117 citations

Clinical and Translational Science Awards

2009 • 115 citations

The Value of Neuraminidase Inhibitors for the Prevention and Treatment of Seasonal Influenza: A Systematic Review of Systematic Reviews

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A new statistic and its power to infer membership in a genome-wide association study using genotype frequencies

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Publication and non-publication of clinical trials: longitudinal study of applications submitted to a research ethics committee

2008 • 110 citations

Challenges of subgroup analyses in multinational clinical trials: Experiences from the MERIT-HF trial

2001 • 110 citations

Clinical trials update: OPTIME‐CHF, PRAISE‐2, ALL‐HAT

2000 • 110 citations

Sex and haemodynamics in pulmonary arterial hypertension

2013 • 107 citations

Publication of Trials Funded by the National Heart, Lung, and Blood Institute

2013 • 106 citations

Defining and testing EMR usability: Principles and proposed methods of EMR usability evaluation and rating.

2009 • 104 citations

Private lives and public policies: confidentiality and accessibility of government statistics

1994 • 104 citations

Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials

2014 • 103 citations

Oseltamivir and Risk of Lower Respiratory Tract Complications in Patients With Flu Symptoms: A Meta-analysis of Eleven Randomized Clinical Trials

2011 • 103 citations

Alzheimer's Disease Risk Assessment Using Large-Scale Machine Learning Methods

2013 • 99 citations

The Importance of Clinical Trial Data Sharing

2012 • 96 citations

Effect of variability in the 7-day baseline pain diary on the assay sensitivity of neuropathic pain randomized clinical trials: An ACTTION study

2014 • 93 citations

The Role of Genetics in Craniofacial Morphology and Growth

1991 • 87 citations

Identifiability in biobanks: models, measures, and mitigation strategies

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Estimating the re-identification risk of clinical data sets

2012 • 86 citations

Providing Research Results to Participants: Attitudes and Needs of Adolescents and Parents of Children With Cancer

2009 • 84 citations

Research for universal health coverage: World health report 2013

2015 • 84 citations

Anonymizing Health Data: Case Studies and Methods to Get You Started

2013 • 81 citations

Assessing Identification Risk in Survey Microdata Using Log-Linear Models

2008 • 80 citations

The International Stroke Trial database

2011 • 80 citations

Federal Policy for the Protection of Human Subjects (“Common Rule”)

2014 • 78 citations

Clinical study reports of randomised controlled trials: an exploratory review of previously confidential industry reports

2013 • 74 citations

LONDON, Royal Society

2014 • 72 citations

Bias in reporting clinical trials

1998 • 72 citations

Ethics and Informed Consent for Comparative Effectiveness Research With Prospective Electronic Clinical Data

2013 • 71 citations

How disease advocacy organizations participate in clinical research: a survey of genetic organizations

2012 • 70 citations

An ethical framework for biomedical research

2008 • 69 citations

Community-Based Participatory Research: Its Role in Future Cancer Research and Public Health Practice

2013 • 68 citations

Large-Scale Privacy-Preserving Mapping of Human Genomic Sequences on Hybrid Clouds.

2012 • 65 citations

The Ontology of Clinical Research (OCRe): An informatics foundation for the science of clinical research

2013 • 65 citations

Data Sharing in Medical Research: An Empirical Investigation

2001 • 63 citations

Transparency in Three Dimensions

2011 • 62 citations

De-identification Methods for Open Health Data: The Case of the Heritage Health Prize Claims Dataset

2012 • 61 citations

Caught you: threats to confidentiality due to the public release of large-scale genetic data sets

2010 • 61 citations

Determining the identifiability of DNA database entries.

2000 • 60 citations

Dissociable Effects of Alzheimer Disease and White Matter Hyperintensities on Brain Metabolism

2013 • 60 citations

Using binning to maintain confidentiality of medical data.

2002 • 56 citations

Protecting Genomic Sequence Anonymity with Generalization Lattices

2005 • 56 citations

Power to the People : Participant Ownership of Clinical Trial Data

2011 • 55 citations

3. Exploitation in Clinical Research

2008 • 54 citations

Covariate adjustment of treatment effects in clinical trials

1991 • 54 citations

Equal Employment Opportunity Commission (EEOC)

2015 • 53 citations

Building community partnerships: case studies of Community Advisory Boards at research sites in Peru, Zimbabwe, and Thailand

2008 • 51 citations

Much Ado about Data Ownership

2011 • 49 citations

Predicting Human Age with Bloodstains by sjTREC Quantification

2012 • 46 citations

For Attribution -- Developing Data Attribution and Citation Practices and Standards: Summary of an International Workshop

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Invasion of privacy.

1997 • 44 citations

A Model for Dissemination and Independent Analysis of Industry Data

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2012 • 40 citations

Towards Principles–Based Approaches to Governance of Health–Related Research Using Personal Data

2013 • 39 citations

On identification disclosure and prediction disclosure for microdata

1992 • 39 citations

Pharma Firms Push for Sharing of Cancer Trial Data

2012 • 38 citations

NCES Statistical Standards.

1992 • 37 citations

Approaches and Costs for Sharing Clinical Research Data

2014 • 37 citations

A Case Study of the Impact of Statistical Disclosure Control on Data Quality in the Individual UK Samples of Anonymised Records

2007 • 36 citations

Liability issues for data monitoring committee members

2004 • 35 citations

Privacy Technology to Support Data Sharing for Comparative Effectiveness Research

2013 • 31 citations

Information about the

1998 • 31 citations

Project Data Sphere to Make Cancer Clinical Trial Data Publicly Available

2013 • 29 citations

We want raw data, now

2009 • 29 citations

A method for managing re-identification risk from small geographic areas in Canada

2010 • 29 citations

Access to social security microdata files for research and statistical purposes.

1978 • 26 citations

Statistical Disclosure Limitation Practices of United States Statistical Agencies

1993 • 26 citations

Improvements on a privacy-protection algorithm for DNA sequences with generalization lattices

2011 • 25 citations

Enabling reproducible research: Licensing for scientific innovation

2009 • 25 citations

Home Health Services Research

2002 • 23 citations

Are clinical trial data shared sufficiently today? Yes

2013 • 23 citations

GlaxoSmithKline opens the door on clinical data sharing

2012 • 23 citations

WhatBig Datameans to me

2014 • 23 citations

Research and confidentiality: Legal issues and risk management strategies.

2011 • 22 citations

Enabling Genomic-Phenomic Association Discovery without Sacrificing Anonymity

2013 • 22 citations

Drugs in Search of Diseases

2013 • 21 citations

Secure use of individual patient data from clinical trials

2013 • 21 citations

Measuring the Impact of Data Protection Techniques on Data Utility: Evidence from the Survey of Consumer Finances

2006 • 21 citations

(9576) van der Weyden

2003 • 21 citations

Preparing individual patient data from clinical trials for sharing: the GlaxoSmithKline approach

2014 • 21 citations

Risk of bias in industry-funded oseltamivir trials: comparison of core reports versus full clinical study reports

2014 • 20 citations

Meeting the obligation to communicate clinical trial results to study volunteers

2012 • 20 citations

2008 HIMSS analytics report: security of patient data.

2008 • 19 citations

Differential Privacy: A Cryptographic Approach to Private Data Analysis

2014 • 18 citations

Research Privacy Under HIPAA and the Common Rule

2005 • 18 citations

Drug Watchdog Ponders How to Open Clinical Trial Data Vault

2013 • 18 citations

Centralized medical monitoring in phase III clinical trials: the National Surgical Adjuvant Breast and Bowel Project (NSABP) experience

2006 • 17 citations

Sharing data from clinical trials: where we are and what lies ahead

2013 • 17 citations

FDA panel advises easing restrictions on rosiglitazone

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Data Safety Monitoring Boards: Legal and Ethical Considerations for Research Accountability

2010 • 16 citations

A View on Statistical Disclosure Control for Microdata

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Use Patents, Carve-Outs, and Incentives — A New Battle in the Drug-Patent Wars

2012 • 14 citations

Participants' preference for type of leaflet used to feed back the results of a randomised trial: a survey

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To Blank or Not to Blank? A Comparison of the Effects of Disclosure Limitation Methods on Nonlinear Regression Estimates

2004 • 12 citations

Casebook on Ethical Issues in International Health Research

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Effects of Rounding on the Quality and Confidentiality of Statistical Data

2006 • 10 citations

The Prompted Optional Randomization Trial: A New Design for Comparative Effectiveness Research

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BIO-Biotechnology Industry Organization

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Use Patents Can Be Useful: The Case of Rescued Drugs

2014 • 8 citations

Economic Effects of Product Liability and Other Litigation Involving the Safety and Effectiveness of Pharmaceuticals

2013 • 8 citations

The status of clinical trials: Cause for concern

2010 • 7 citations

Integrated guidelines for developing epidemiologic profiles : HIV prevention and Ryan White CARE Act community planning

2004 • 7 citations

Creation of public use files: lessons learned from the comparative effectiveness research public use files data pilot project

2011 • 6 citations

ecancermedicalscience

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IOM Outlines Framework for Clinical Data Sharing, Solicits Input

2014 • 4 citations

US committee calls for comments on how to share clinical trial data

2014 • 2 citations

Reply to Cochrane Neuraminidase Inhibitors Review Team

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FDA creates task force to make its work more transparent

2009 • 1 citations

Study Protocol Representation

2012 • 1 citations

Deleted Work

1955 • 0 citations