In reality, that recruitment function may be much more limited. "It will vary by condition," Bacon says. "Most expect that
it will prove a useful tool only for those who used it before: patients with orphan or life-threatening diseases who are motivated
to get on the Web and seek out clinical trials."
Most stakeholders agree that clinical trial registries are a good idea—they just don't agree on specifics. ICMJE wants companies
to register all "clinically-directive trials"—those whose primary purpose is to affect clinical practice—before they enroll
their first patient. And they're not the only ones. The Fair Access to Clinical Trials Act introduced to Congress in October
2004, requires companies to register research at clinicaltrials.gov/. In addition, the World Health Organization (WHO) has designated a registration advisory group to establish a clinically
meaningful trial registration process.
Some subscribers are taking the online-only subscription. That leads us to an interesting situation for advertising because,
so far, companies have not embraced the Web as an ad vehicle. –Lenne P. Miller, senior director of publications for the Endocrine
However, some say medical journal editors aren't the most appropriate gatekeepers: "Publishers certainly have cause for concern
if they feel the flow of manuscript submissions is being biased based on interference from grantors," says John Carter, vice
president of publishing operations for Slack. "But I'm not sure that a new entity formed by a group of publishers is the most
appropriate body to address these issues."
No nonsense ICMJE recently published an editorial updating the specifics of working with trial registries. Among other changes, the group
has adopted WHO's 20-item questionnaire to collect the basic information companies must provide to register a trial. Editors
emphasized that authors must fill out items completely and with relevant information.
If an article comes out of a registry so it is possible to trace the trial through its various stages, it would make the review
a lot easier. In theory, it would even make it faster and better. But we're a long way from having that. –George Lundberg,
MD, editor of Medscape General Medicine.
"Trial sponsors don't always enter useful information into the field called 'intervention,'" Sox says. "They say 'investigational
new drug' instead of Vioxx, for example. That's contrary to the spirit of the registry—it deliberately misleads people. Eventually,
authors and sponsors will get the word that if they don't input useful information into each field, we'll refuse to consider
Peer review "Peer review is where the rubber meets the road in journal publishing," Bacon says. But the question remains: Can the peer
review process use registries to make pharma-sponsored research truly transparent?
We know a large percentage of authors are willing and able to pay publication charges for open access. It's possible there
will be a general perception that costs will create more reliance on pharma companies for dollars to sponsor studies. However,
the solution to this is to adopt a policy of transparency. –Martin Richardson, director of Oxford Journals