Publication of Trials Involving Unsuccessful Interventions

by

Publication of Trials Involving Unsuccessful Interventions: An Empirical and Ethical Analysis

Lead Investigator: Jonathan Kimmelman
Software Engineer: Benjamin Carlisle
Research Assistants: Georgina Freeman, Amanda Hakala

 

INTRODUCTION

The clinicaltrials.gov public database is a great tool for encouraging data transparency in clinical research.  However, requirements for publication of registered clinical trial data only pertain to licensed drugs and studies investigating treatment of disorders identified within the labeling application. As a consequence, there are few incentives for researchers to publish trials either outside labeling, or for drugs that are not licensed.

In order to assess the effect of this lack of incentive, we planned a survey of publication practices for clinical trials outside of labelling and in unlicensed drugs.

 

DESIGN

We performed a systematic literature review to assess publication rates for cohorts of drugs that either received FDA licensure between 2000 and 2009 (translated drugs), or that stalled during this same time period (stalled drugs). In our study, stalled drugs are defined as drugs for which there is no FDA approval and no registered, or ongoing clinical trials after December 31, 2008, allowing a >3 year window with no further investigations or development of the drug.

We contacted investigators on registered clinical trials for which no publication could be found. Our short survey sought to identify barriers to publication, to help inform incentive structures in support of investigator reporting.

 

PROTECTION FOR SURVEY RESPONDENTS

Our protocol has been reviewed and approved by McGill’s Institutional Review Board (IRB). Questionnaires were sent by email. Positive responses will be interpreted as consent.

Questionnaire responses will be automatically uploaded into a password protected online database maintained by the STREAM research group. Access to the database can only be granted by our project software engineer (BC) and will only be granted to the primary investigator (JK), and research assistants (GF, AH). All electronic copies of responses will be anonymized. All original data from the questionnaires will be kept for five years as per the McGill Policy on Research Ethics. No demographic information about investigators will be collected. No identifying information will be published.

 

WHO WE ARE

This study is being led by Jonathan Kimmelman, a researcher in the Biomedical Ethics Unit / Social Studies of Medicine at McGill University and head of the STREAM research team. You can learn more about Dr. Kimmelman and the STREAM team at http://www.translationalethics.com/members/.

 

Questions

Should you have questions or concerns about our study, please contact jonathan.kimmelman@mcgill.ca or georgina.freeman@mcgill.ca.

 

BibTeX

@Manual{stream2013-450,
    title = {Publication of Trials Involving Unsuccessful Interventions},
    journal = {STREAM research},
    author = {Amanda Hakala},
    address = {Montreal, Canada},
    date = 2013,
    month = dec,
    day = 2,
    url = {http://www.translationalethics.com/publication-of-trials-involving-unsuccessful-interventions/}
}

MLA

Amanda Hakala. "Publication of Trials Involving Unsuccessful Interventions" Web blog post. STREAM research. 02 Dec 2013. Web. 11 Dec 2018. <http://www.translationalethics.com/publication-of-trials-involving-unsuccessful-interventions/>

APA

Amanda Hakala. (2013, Dec 02). Publication of Trials Involving Unsuccessful Interventions [Web log post]. Retrieved from http://www.translationalethics.com/publication-of-trials-involving-unsuccessful-interventions/


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