WHO network and standards for existing trial registries
WHO network and standards for existing trial registries
Registries may help research participants
Fifty-two health ministers met in Mexico in May, 2005, at the 58th World Health Assembly and decided to establish a network of clinical trial registries and a single search portal.
Known as the Mexican Statement, the result was recommendations for registration and a voluntary platform that links clinical trial registries across the globe, says Davina Ghersi, MPH, coordinator of the World Health Organization's International Clinical Trials Registry Platform in Geneva, Switzerland.
One of the chief purposes behind clinical trial registries is to provide accountability and greater transparency to the research process, giving potential research participants and the public access to some basic information about trials from a study's beginning to its end.
"The key thing about WHO's effort is that we're not creating a trials registry, but creating a network of existing trials registries," Ghersi says. "And we're developing norms and standards for registries so they can all share information in a uniform way."
The registry platform is in an early stage, and WHO still doesn't know how many registries exist, although the key registries are in the United States (www.clinicaltrials.gov), the United Kingdom, and Australia, Ghersi says.
Also, the platform has created a list of 20 dataset items that should be included for every study on a registry.
Clinical trial registries are a small response to publication bias.
"Publication bias is when you select whether or not to publish your trial, and you select which information to publish in the study," Ghersi says. "We've known for a long time that you're more likely to publish your trial if it has significant, positive results."
But now with more of a focus on evidence-based medicine and the increased activism of consumer groups, the public wants better information with which to make informed decisions, Ghersi says.
"It's difficult to make a decision when you're only told one part of the story," Ghersi says. "And from the journals' perspective, there is limited space and they can't publish everything."
With the Internet and electronic publishing, there is the potential to make a great deal more information available to the public, and this is where open access, online journals, such as those published by the Public Library of Science come in handy, Ghersi notes.
Clinical trial registries are the second part to the solution because they let scientists and the public know about studies that were initiated but, perhaps, never reported at conclusion. Also, online journals that publish such registered studies can provide links to these initial registries and people can draw conclusions based on differences between what was initially presented versus what was finally reported.
"There are studies that would never be reported because they may not be significant, or they may be small," Ghersi says. "They're the ones we need to know about, and that's where registries can be useful."
In the long run, it will be consumers who dictate how much information will be made available with regard to research, Ghersi says.
"I think there will be pressure to register and make the results available," Ghersi says. "We're almost there -- people are accepting that we need to register clinical trials, and we have an obligation to people who take part in research."
Fifty-two health ministers met in Mexico in May, 2005, at the 58th World Health Assembly and decided to establish a network of clinical trial registries and a single search portal.Subscribe Now for Access
You have reached your article limit for the month. We hope you found our articles both enjoyable and insightful. For information on new subscriptions, product trials, alternative billing arrangements or group and site discounts please call 800-688-2421. We look forward to having you as a long-term member of the Relias Media community.