2005 has seen a vigorous discussion around a document from CDISC on e-source, or clinical trials without paper "source" documents. CDISC's document could become the starting point for a regulatory guidance in coming years.
A few recent eCliniqua stories detailed vendor and sponsor views on the issue of how technology needs to conform to existing and anticipated regulation. Now it's time for the thoughts of an official who enjoys close access to the process by which CDISC volunteers and the FDA are examining both e-source technology and the role standards may play in facilitating the use of e-source.
eCliniqua is not in the habit of letting interviewees speak off the record. But then we got to chatting with this well-placed individual. This person is quite familiar with the internal thinking about e-source at the FDA. This individual periodically receives email with radioactivity at levels considered unsafe by the Nuclear Regulatory Commission. This time around, our source would like to avoid any re-inflammation of the e-source debate. It is the holidays, after all.
One factor underpinning the CDISC-FDA collaboration on e-source is time. Changing anything in any bureaucracy takes so long that all parties hoped to come up with something to facilitate the use of e-source and data standards now. "The FDA people want to encourage the use of e-source technology," our source says. "But they want to stay good on predicate rules, which they can't readily change."
CDISC's working group on e-source includes representatives of clinical sites, sponsors, validation experts, and CROs. It is also working with other industry task forces. One critique of the drafting of the CDISC e-source document is that some of the organizations that know the technology best-vendors-have been excluded from the process.
This isn't true. There are vendors involved. But they are discreet and not inclined to push one particular product or solution. Says our source: "The FDA has heard from the vendors on this topic for years. They tend to take over conversations. Then people that the FDA has not heard from don't talk."
One major issue is a requirement proposed in the CDISC document. To wit: Sponsors should not have exclusive control over source data. The CDISC document recommends that the investigator should be able to access the source data at all times. If changes to the data are necessary, investigators must be aware of the changes or make the changes themselves.
For people at FDA and in the CDISC e-source working group, there is wide agreement that the central role of the investigator should not be circumvented by technology. Rather, the role of the investigator is sacrosanct under current guidance. The FDA simply has no room to maneuver here. Clinical investigator access to his or her own data should supersede any shiny new bells and whistles the vendor community may offer.
"If the data flow to the sponsor and the investigator never sees these data, or only sees them at the end of the trial, that's not the way it should be done," our source says. "If the data is on some sponsor's system and the investigator can't access it, that's not a good thing."
CDISC received more than 500 comments on its currently posted e-source document. Another draft should be ready in the first quarter of 2006. The next version will more fully describe methods and scenarios through which e-source can be deployed within existing regulations and through the use of available industry standards.
And in the meantime? "If sponsors have the only source database in-house," says our contact, "they may need to make sure they provide appropriate controls and access for investigators. That's an issue. They should document their processes in light of the requirements listed in the e-source document. But this is fixable."
Online registration is now available for Bio-IT World's 2006 Life Sciences Conference + Expo, to be held this April 3-5, 2006, in Boston, Massachusetts. Registration details are here.