Liberating the data from clinical trials

  title={Liberating the data from clinical trials},
  author={David Henry and Tiffany Fitzpatrick},
  journal={BMJ : British Medical Journal},
Liberated trial data have enduring potential to benefit patients, prevent harm, and correct misleading research 
Benefits of, and barriers to, reactivating dormant trials
The UK should follow Ontario and reactivate its treasure trove of dormant trials to generate new science through linkage with administrative data to monitor long term safety of drugs.
Data sharing is desirable, but benefits should not be exaggerated
On behalf of the Diabetes Control and Complications Trial/Epidemiology of Diabetes Interventions and Complications (DCCT/EDIC) research group, we thank Henry and Fitzpatrick for their praise of how
Assessment of Long-term Follow-up of Randomized Trial Participants by Linkage to Routinely Collected Data
The fate of patients after participation in clinical trials is a neglected topic, and the authors recommend that researchers routinely request permission from trial participants to study long-term treatment effects using linkage to routinely collected data.
Protocol for a scoping review of post-trial extensions of randomised controlled trials using individually linked administrative and registry data
This scoping review aims to characterise published post-trial extension studies, assess their value, and identify any potential challenges associated with this approach, to produce guidance for investigators on the conduct of post- trial extensions using routinely collected data.
Inauguration of the Journal of Emergency and Critical Care Medicine
Emergency and critical care medicine are specialties facing life-threatening emergencies such as stroke, acute myocardial infarction, and severe trauma and most practices in emergency room and intensive care unit (ICU) lack high-level evidence.
Antidepressants: Conundrums and Complexities of Efficacy Studies
  • R. Pies
  • Psychology
    Journal of clinical psychopharmacology
  • 2016
Despite the apparent failure of Study 329, the preponderance of research still supports modest-to-moderate efficacy—and overall safety—for several commonly used antidepressants, and influential meta-analyses suggesting that the efficacy of antidepressants for major depression is exaggerated and/or limited to severe depression.
[Pharmacovigilance in Germany : It is about time].
Without publicly funded large longitudinal healthcare databases and an amendment of Section 75, Book 10, of the Code of Social Law, the use of healthcare data in pharmacovigilance research in Germany will remain a rarity.
If you build it, they will come: unintended future uses of organised health data collections
The main purpose of this paper is to raise awareness of the potential for unforeseen and unintended consequences of the increased availability and development of health data collections for research, by providing a comprehensive review of documented and hypothetical non-health research uses of such data.
Investing in Endovascular Thrombectomy Programs: Saving Lives, Saving Money.
  • A. Kuczynski, M. Vyas
  • Economics
    The Canadian journal of neurological sciences. Le journal canadien des sciences neurologiques
  • 2021
This is a manuscript accepted for publication in Canadian Journal of Neurological Sciences. This version may be subject to change during the production process. Investing in Endovascular Thrombectomy
Repository Assessment of Long-term Follow-up of Randomized Trial Participants by Linkage to Routinely Collected Data : A Scoping Review and Analysis
A scoping review of randomized clinical trials extended by record linkage to characterize this literature and explore any additional insights into treatment effectiveness provided by long-term follow-up using record linkage found some benefits of treatment extend beyond the trial, and some harms of treatment only become apparent after the trial is complete.


The BMJ requires data sharing on request for all trials
Heeding calls from the Institute of Medicine, WHO, and the Nordic trial Alliance, the Nordic Trial Alliance is extending its policy to include cannabis use in clinical trials across Europe.
All trials must be registered and the results published
Academics and non-commercial funders are just as guilty as industry of misleading the public about the role of science in society.
Restoring invisible and abandoned trials: a call for people to publish the findings
Peter Doshi and colleagues call for sponsors and investigators of abandoned studies to publish (or republish) and propose a system for independent publishing if sponsors fail to respond.
Sharing clinical trial data: maximizing benefits, minimizing risk.
It is concluded that sharing data is in the public interest, but a multi-stakeholder effort is needed to develop a culture, infrastructure, and policies that will foster responsible sharing—now and in the future.
No correction, no retraction, no apology, no comment: paroxetine trial reanalysis raises questions about institutional responsibility
  • P. Doshi
  • Medicine
    BMJ : British Medical Journal
  • 2015
The resistance to action of a professional society, its journal, and an Ivy League university is examined as a new data analysis adds weight to calls for retraction of a paper on paroxetine in adolescents.
Reanalyses of randomized clinical trial data.
Thirty-five percent of published reanalyses of RCT data led to changes in findings that implied conclusions different from those of the original article about the types and number of patients who should be treated.
Effectiveness of public report cards for improving the quality of cardiac care: the EFFECT study: a randomized trial.
Whether the public release of data on cardiac quality indicators effectively stimulates hospitals to undertake quality improvement activities that improve health care processes and patient outcomes is evaluated.
Effect of telehealth on use of secondary care and mortality: findings from the Whole System Demonstrator cluster randomised trial
Telehealth is associated with lower mortality and emergency admission rates, and differences in emergency admissions were greatest at the beginning of the trial, during which the authors observed a particularly large increase for the control group.
Are Routinely Collected NHS Administrative Records Suitable for Endpoint Identification in Clinical Trials? Evidence from the West of Scotland Coronary Prevention Study
It is concluded that routinely collected data could be used for recording cardiovascular endpoints in clinical trials and would give very similar results to rigorously collected clinical trial data, in countries with unified health systems such as Scotland.
Outcomes of a randomized controlled trial of a clinical pharmacy intervention in 52 nursing homes.
This intervention improved nursing home resident outcomes related to changes in drug use and drug-related expenditure and suggests that the difference would have been more significant in a larger and longer study, and even more so using additional instruments specific for measuring outcomes related for changes indrug use.