Turn the Page - Pharmaceutical Executive


Turn the Page
Changes in ethics and expectations are driving the way pharma interacts with medical publishers.

Pharmaceutical Executive

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."

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 Society.
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.

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."

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.
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.

"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 the trial."

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
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?


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