Clinical trials need to better protect participants and research integrity as data accumulate

An Essay by Susan Ellenberg from the University of Pennsylvania describes alternative approaches to the evaluation of clinical trials, with the objectives both of preventing undue risks to participants and protecting the integrity of data.

Writing in this week's , the author outlines the importance of methods for ensuring independence of those involved in analysis of interim data, and for ensuring that early stopping guidelines are clearly laid out before a trial starts.

However, the author emphasises that issues around liability for individuals who provide these functions are currently unclear, and concludes: "DMCs [data monitoring committees] have become expected components of many , and provide an important oversight function".

More information: Ellenberg SS (2012) Protecting Clinical Trial Participants and Protecting Data Integrity: Are We Meeting the Challenges? PLoS Med 9(6): e1001234. doi:10.1371/journal.pmed.1001234

Related Stories

Clinical trials often fall short

date May 01, 2012

Clinical studies registered in clinicaltrials.gov between 2007-2010 are dominated by small, single-center trials and contain significant heterogeneity (different in nature, difficult to compare) in methodological approaches, ...

Half of trials supporting FDA applications go unpublished

date Sep 23, 2008

Over half of all supporting trials for FDA-approved drugs remained unpublished 5 years after approval, says new research published in this week's PLoS Medicine. The most important trials determining efficacy, and those with s ...

Useful stroke trials left unpublished

date Apr 22, 2010

An investigation into unpublished stroke research data has revealed that 19.6% of completed clinical trials, which could potentially influence patient care, are not published in full. Researchers writing in BioMed Central's ...

Recommended for you

Game shows mosquito's-eye view of malaria

date Apr 24, 2015

A new game about the life cycle of malaria that can be played on Android smartphones has been created by an Oxford University developer, based on malaria research at the University's Nuffield Department of ...

DMV program can generate additional organ donors

date Apr 23, 2015

(HealthDay)—A brief, web-based training program for department of motor vehicles (DMV) employees that educates them about organ and tissue donation can increase the likelihood of customers registering as ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.