UPenn's clinical trials registry going public
UPenn's clinical trials registry going public
Site follows same format as ClinicalTrials.gov
The University of Pennsylvania in Philadelphia rolled out its own on-line clinical trials registry nearly a year ago as a trials recruitment tool.
"We felt that if we could get information about studies out to all of our physicians at Penn's various hospitals and clinical care centers in the Philadelphia area, then they would find studies appropriate for their patients and mention them," says Adam P. Rifkind, Esq, associate director of corporate contracts in the office of research services.
The university's clinical trials registry was designed purposely to complement the Clinical Trials Data Bank, sponsored by the National Library of Medicine at ClinicalTrials.gov, he notes.
Both use the same data fields in the registration form. "We did that for several reasons, and the chief one is so that there will be a consistency as to what we put on our sites and as to what's put on clinicaltrials.gov," Rifkind says.
Eventually, investigators and clinical trials professionals will be able to send the registry information out to both sites without having to complete two separate forms. Currently, they can easily copy information from one form to the other, he says.
The goal is to have the web site, called ClinicalTrials@Penn, open to the general public, and when that happens it also will serve as a public recruitment tool, Rifkind says.
"People in the Philadelphia area are familiar with the university, and this will help them focus their search for a clinical trial," Rifkind says.
Another purpose behind the registry is to make clinical trial information more available to the general public in order to provide a meaningful discussion of results, Rifkind says.
"It's fundamental to the research purpose of this university to disseminate the information we gather from our research," Rifkind says. "We are very diligent in maintaining the ability to publish results of research regardless of the source of the sponsor, the funds, or the protocol."
University officials have been introducing new language in clinical trial agreements with industry sponsors to allow them to register information that would be found on ClinicalTrials.gov, Rifkind says.
"That's why we mimic the government registry site, because our sponsors are comfortable and familiar with what information is going on that web site," Rifkind says.
"Of course, with Penn-sponsored research we don't have to get sponsors' permission, but for industry-sponsored research, sometimes sponsors consider protocols and exclusion/inclusion criteria and primary and secondary endpoints to be confidential information," he adds.
This is why agreements have language to allow the institution's use of certain information on ClinicalTrials@Penn, he adds.
Once the information is put on ClinicalTrials.gov, it is no longer confidential, so the university is free to use the same data on its own registry, he adds.
Rifkind, who spent eight years of his career at a major pharmaceutical company, says he can see why industry sponsors desire confidentiality over clinical trials information, but he also understands why the public and medical journal editors are pushing for more transparency in research.
"I think it's better to have more openness and more transparency because in order to educate consumers they need a better idea of what information is out there, so they can self-educate," Rifkind says.
"Also, it helps the media and academia to disseminate information about what is known about a compound and class of compounds, if they know what trials have been run," Rifkind says.
For example, when people are considering participation for a particular drug X that will be used to treat one particular disease, they often do not know that the same drug X had been used to treat an entirely different disease, but was dropped because of safety concerns, Rifkind says.
However, drug X is revived because it's now intended to treat a more dangerous disease and its risk-benefits ratio is different, he explains.
With a clinical trials registry, potential participants in such a trial can more easily find out about previous research on any given therapy, and this will empower them to make a more educated decision about whether or not to participate.
"The informed consent can list all kinds of things that might happen to you, and it can say, 'And you might die,'" Rifkind says. "But if you knew about an earlier study in which a number of people who participated had died, then you might take that information in the informed consent a little more seriously."
Eventually, the Penn registry will be comprehensive. "Our goal is to have all clinical trials conducted at Penn put on the registry," Rifkind says.
The university used existing staff to design and implement the registry, and at this time, there are no ongoing data entry costs since the investigators and clinical trials staff put all of the information into the on-line registry form, Rifkind says.
"I think it's most accurate to say the data entry responsibilities fall on existing personnel," he says.
Investigators and clinical trials professionals easily accepted the registry since they already completed the same information for the NLM's registry, Rifkind adds.
"Our only problem now is ensuring the information is in a format that the layman will understand," Rifkind says.
The University of Pennsylvania in Philadelphia rolled out its own on-line clinical trials registry nearly a year ago as a trials recruitment tool.Subscribe Now for Access
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