Featured Research

from universities, journals, and other organizations

Few Studies Consider The Appropriate Measurements For Assessing Clinical Trials In Children

Date:
April 28, 2008
Source:
Public Library of Science
Summary:
Very few studies have asked what the appropriate measurements are for assessing treatments in clinical trials in children, according to a systematic review of pediatric clinical research conducted since 1950.

Very few studies have asked what the appropriate measurements are for assessing treatments in clinical trials in children, according to a systematic review of paediatric clinical research conducted since 1950. The review by Ian Sinha and colleagues from the University of Liverpool also shows that few studies have involved parents and none have involved children in the process to select which measurements to use to assess clinical trials.

Related Articles


Before conducting a clinical trial of a new drug, researchers choose several "outcomes." These are measurements chosen in advance of the trial to ensure that as much information as possible is provided about the drug's safety, effectiveness and its impact on the patients' health and daily life. Children's bodies handle certain drugs very differently to adults -- it can't just be assumed that drugs effective in adults simply need to be scaled down to work for children -- and so paediatric clinical trials need to be designed with these differences in mind.

By using a search strategy and consulting experts in paediatric clinical research, the researchers identified all the studies since 1950 that have examined the selection of outcomes in clinical trials conducted in children. Their initial search was very wide to minimize bias, leading to the retrieval of 9,000 abstracts. Only twenty-five articles met the criteria established by the review and examined the selection of outcomes in clinical research in children. These studies came from thirteen groups researching different conditions -- including asthma, Crohn's disease and cystic fibrosis -- but for many paediatric areas there has been no work done into the selection of appropriate outcomes for clinical trials in children.

Reaching agreement on standard outcomes for clinical trials in children is important because it enables researchers and clinicians to compare and combine the results of clinical trials. Standardization also helps avoid selectivity and bias in the conduct of research. Several of the studies reviewed by Ian Sinha and colleagues used methods that had previously been used to select outcomes in clinical trials in adults. These include a technique in which individual opinions are sought and fed back into a group discussion before a final consensus agreement is reached, as well as a technique that involves face-to-face discussion followed by a vote. But although the groups selecting the appropriate outcomes in these studies included clinical experts and specialists in a particular paediatric condition, only three groups asked parents about the outcomes that should be included to assess the clinical trials and none of them asked children directly.

In an accompanying perspective, Mike Clarke of the UK Cochrane Centre and Trinity College, Dublin - not involved in the systematic review - suggests the approaches identified should "make it easier to plan, appraise and use initiatives that have already attempted to standardize outcomes." But as Ian Sinha and colleagues conclude, further research is urgently required to make this process easier and more uniform and to involve children and their parents in assessing which outcomes should be used in clinical trials.

Citation: Sinha I, Jones L, Smyth RL, Williamson PR (2008) A systematic review of studies that aim to determine which outcomes to measure in clinical trials in children. PLoS Med 5(4): e96.


Story Source:

The above story is based on materials provided by Public Library of Science. Note: Materials may be edited for content and length.


Cite This Page:

Public Library of Science. "Few Studies Consider The Appropriate Measurements For Assessing Clinical Trials In Children." ScienceDaily. ScienceDaily, 28 April 2008. <www.sciencedaily.com/releases/2008/04/080428200304.htm>.
Public Library of Science. (2008, April 28). Few Studies Consider The Appropriate Measurements For Assessing Clinical Trials In Children. ScienceDaily. Retrieved November 23, 2014 from www.sciencedaily.com/releases/2008/04/080428200304.htm
Public Library of Science. "Few Studies Consider The Appropriate Measurements For Assessing Clinical Trials In Children." ScienceDaily. www.sciencedaily.com/releases/2008/04/080428200304.htm (accessed November 23, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Sunday, November 23, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

Ebola-Hit Sierra Leone's Late Cocoa Leaves Bitter Taste

AFP (Nov. 23, 2014) The arable district of Kenema in Sierra Leone -- at the centre of the Ebola outbreak in May -- has been under quarantine for three months as the cocoa harvest comes in. Duration: 01:32 Video provided by AFP
Powered by NewsLook.com
Don't Fall For Flu Shot Myths

Don't Fall For Flu Shot Myths

Newsy (Nov. 23, 2014) Misconceptions abound when it comes to your annual flu shot. Medical experts say most people older than 6 months should get the shot. Video provided by Newsy
Powered by NewsLook.com
WFP: Ebola Risks Heightened Among Women Throughout Africa

WFP: Ebola Risks Heightened Among Women Throughout Africa

AFP (Nov. 21, 2014) Having children has always been a frightening prospect in Sierra Leone, the world's most dangerous place to give birth, but Ebola has presented an alarming new threat for expectant mothers. Duration: 00:37 Video provided by AFP
Powered by NewsLook.com
Could Your Genes Be The Reason You're Single?

Could Your Genes Be The Reason You're Single?

Newsy (Nov. 21, 2014) Researchers in Beijing discovered a gene called 5-HTA1, and carriers are reportedly 20 percent more likely to be single. Video provided by Newsy
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:

Breaking News:

Strange & Offbeat Stories


Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile: iPhone Android Web
Follow: Facebook Twitter Google+
Subscribe: RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins