Preparing for Responsible Sharing of Clinical Trial Data
New England Journal of MedicinePublished 21 October 2013Open access
Michelle M. Mello, Jeffrey Francer, Marc Wilenzick, Patricia Teden, Barbara E. Bierer, Mark Barnes
Citations182
SJR quartileQ1
SJR score19.08
SNIP13.47
Generate an AI Snapshot to get a quick, structured summary of this paper.
Study Snapshot
ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
OutcomesStudy outcomes here
ResultsStudy results comes here
LimitationsResearch study limitations comes here
A concise AI-generated summary of the paper will appear here once you click Generate AI Snapshot.
TL;DR
The authors review the potential benefits and unintended consequences of the broad sharing of participant-level data from clinical trials and several options for governance structures that could be implemented to provide expanded access to clinical trial data are discussed.
Abstract
The authors review the potential benefits and unintended consequences of the broad sharing of participant-level data from clinical trials. Several options for governance structures that could be implemented to provide expanded access to clinical trial data are discussed.
Keywords
MedicineEconomics, Econometrics and Finance
ScienceIdentifying Personal Genomes by Surname Inference
1,227 Citations2013Melissa Gymrek, Amy L. McGuire +3 more
It is reported that surnames can be recovered from personal genomes by profiling short tandem repeats on the Y chromosome (Y-STRs) and querying recreational genetic genealogy databases and it is shown that a combination of a surname with other types of metadata, such as age and state, can be used to triangulate the identity of the target.
New England Journal of MedicineThe ClinicalTrials.gov Results Database — Update and Key Issues
789 Citations2011Deborah A. Zarin, Tony Tse +3 more
The structure and contents of the results database are summarized, an update of relevant policies are provided, and how the data can be used to gain insight into the state of clinical research are shown.
JAMACharacteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010
523 Citations2012Robert M. Califf
Clinical trials registered in ClinicalTrials.gov are dominated by small trials and contain significant heterogeneity in methodological approaches, including reported use of randomization, blinding, and DMCs.
PLoS ONEEmpirical Study of Data Sharing by Authors Publishing in PLoS Journals
410 Citations2009Caroline Savage, Andrew J. Vickers
It is suggested that journal policies requiring data sharing do not lead to authors making their data sets available to independent investigators, as only one of ten raw data sets requested was received.
JAMAIssues in the Registration of Clinical Trials
218 Citations2007Deborah A. Zarin, Nicholas C. Ide +4 more
Several issues confound the implementation of such a database, including the lack of an accepted format or process for providing summaries of trial results to the public and concerns about disseminating data in the absence of independent scientific review.
PLoS MedicineThe Imperative to Share Clinical Study Reports: Recommendations from the Tamiflu Experience
164 Citations2012Peter Doshi, Tom Jefferson +1 more
Peter Doshi and colleagues describe their experience trying and failing to access clinical study reports from the manufacturer of Tamiflu and challenge industry to defend their current position of RCT data secrecy.
TrialsWhose data set is it anyway? Sharing raw data from randomized trials
149 Citations2006Andrew J. Vickers
Data sharing should come to be seen as an inherent part of conducting a randomized trial, similar to the way in which the clinical trial community considers ethical review and publication of study results.
TrialsWhy we need easy access to all data from all clinical trials and how to accomplish it
138 Citations2011Peter C Gøtzsche
It is argued that the distinction between publicly-funded and industry-funded research is an artificial and irrelevant one, as the interests of the patients must override commercial interests, and why it is a moral imperative to render all results from all trials involving humans, also healthy volunteers, publicly available.
New England Journal of MedicineAccess to Patient-Level Data from GlaxoSmithKline Clinical Trials
123 Citations2013Perry Nisen, Frank W. Rockhold
GlaxoSmithKline is providing access to patient-level clinical trial data under a new policy, and this article reviews the data-access plan.
JAMAUshering in a New Era of Open Science Through Data Sharing
120 Citations2013Joseph S. Ross, Harlan M. Krumholz
A wall surrounds much of clinical research data, sequestering knowledge, impeding the free flow of information, and obscuring a clear view of the totality of evidence relevant to many research questions and clinical decisions.
Journal of Investigative MedicineTechnical and Policy Approaches to Balancing Patient Privacy and Data Sharing in Clinical and Translational Research
116 Citations2010Bradley Malin, David R. Karp +1 more
This work recounts a recent privacy-related concern associated with the publication of aggregate statistics from pooled genome-wide association studies that have had a significant impact on the data sharing policies of National Institutes of Health-sponsored databanks.
PLoS MedicineOpen Clinical Trial Data for All? A View from Regulators
107 Citations2012Hans‐Georg Eichler, Éric Abadie +3 more
Hans-Georg Eichler from the European Medicines Agency and colleagues provide a view from regulators on access to clinical trial data.
Circulation Cardiovascular Quality and OutcomesThe Importance of Clinical Trial Data Sharing
101 Citations2012Joseph S. Ross, Richard Lehman +1 more
By comparing published articles with trial protocols, 50% of efficacy and 65% of harm outcomes per trial have been shown to be incompletely reported and biased toward the reporting of statistically significant findings.
BMJThe new BMJ policy on sharing data from drug and device trials
75 Citations2012F. Godlee, Trish Groves
New England Journal of MedicineParticipant-Level Data and the New Frontier in Trial Transparency
60 Citations2013Deborah A. Zarin
Policies mandating the registration of trials and the reporting of summary results were instituted to provide greater transparency to ensure transparency in clinical trials.
BMJClinical trial data for all drugs in current use
58 Citations2012F. Godlee
This document would like to be made available for independent scrutiny on a case-by-case basis and should be able to be reviewed by a panel of experts.
JAMAA Model for Dissemination and Independent Analysis of Industry Data
43 Citations2011Harlan M. Krumholz, Joseph S. Ross
Current clinical research standards lack sufficiently strong requirements for transparency and availability, and there are no uniform international standards requiring that study protocols, statistical analysis plans, and study results be made available, nor that completed clinical trial data be posted for independent analysis.
SciencePharma Firms Push for Sharing of Cancer Trial Data
41 Citations2012Yudhijit Bhattacharjee
A consortium of pharmaceutical companies hopes to improve the success rate of experimental cancer therapies by getting cancer researchers to share data from clinical trials by creating a repository of data sets from cancer trials called DataSphere.
JAMARestoring Confidence in the Pharmaceutical Industry
34 Citations2013Howard Bauchner, Phil Fontanarosa
There is a need to restore confidence in pharmaceutical companies and the research they sponsor, and several options are available to pharmaceutical companies to help restore credibility and trust in their sponsored research.
BMJMissing clinical trial data: setting the record straight
34 Citations2010F. Godlee, Elizabeth Loder
Urgent action is needed to restore the integrity of the medical evidence base according to the independent review commissioned by the UK government.
JAMARegistering Clinical Trial Results
31 Citations2010James Dabney Miller
The NIH is currently developing this regulation, which will be the important next step in the registration of clinical trials and an important opportunity for the NIH to improve the quality and reliability of clinical research of drugs.
Nature Reviews Drug DiscoveryGlaxoSmithKline opens the door on clinical data sharing
22 Citations2012Charlotte Harrison
Moves to release more data from clinical trials could provide unprecedented opportunities to understand disease biology and drug effects.
ScienceDrug Watchdog Ponders How to Open Clinical Trial Data Vault
18 Citations2013Tania Rabesandratana
JAMAA New Look at an Old Therapy
10 Citations2012Robert M. Califf
The IMMEDIATE trial was designed as a large pragmatic effectiveness trial with the primary goal of examining the effect of GIK on the rate of total mortality at 30 days and at 1 year, but a combination of ambitious investigators and the particulars of the study mechanism combined caused the trial to fall far short of its enrollment goals.
BMJRoche says it will not relinquish control over access to clinical trial data
8 Citations2013Z. Kmietowicz
Campaigners for full transparency of all clinical trial data have responded with incredulity to a statement from the drug company Roche saying that it would continue to hold back certain information and results from research into its drugs.