A Prescription for Transforming Clinical Trials

eClinical 2011: Remedies for the Clinical Trials Machine
The Advocate Becky Kush (CDISC)

By Allison Proffitt

February 3, 2011 | Becky Kush believes we still have work to do on clinical trials. The president and CEO of the Clinical Data Interchange Standards Consortium (CDISC) says, “We haven’t done the real transformational move yet that’s really new and different. And the process is broken.”

Despite many advances in the clinical data space as more trials move from paper records to digital, Kush believes that, “EDC alone is not transforming the process enough...so that we’re really seeing the benefits of some of the technology,” says Kush.

The next step is to use the electronic clinical data in a meaningful way to further research. “What we’ve been working on is what are called interoperability specifications and integration profiles to work with electronic health records (EHRs) to do research.”

Using EHRs for research and safety can be facilitated using an integration profile called Retrieve Form for Data Capture (RFD). The form is created by a remote manager—for example, an EDC company, CRO, or trial sponsor. The form pops up in a patient’s EHR on cue, maybe because the clinician entered an adverse event, or the patient meets an eligibility criterion to enroll in a trial. When it does so, many of the fields will be pre-populated. The doctor or clinician fills in the remaining required data and the form returns to its manager. Security and privacy settings ensure that the form manager only receives appropriate data, and pre-populated forms save clinicians time and decrease errors.

“You don’t have to transcribe the data in such a research study,” explains Kush. “We call it single source because you can enter the data once and it’s used for multiple purposes instead of transcribing everything.”

Surprisingly perhaps, RFD and integration between EHRs and research is already a function in many EHRs. “AllScripts, Cerner, GE, Greenway Medical, the vast majority of the larger EHR players are ready to do this because it allows them to use their EHR for research without configuring their entire EHR in a different way for every sponsor,” says Kush. “They’re all set and ready to go.” EHR vendors have already rigorously tested the process and it meets Title 21 CFR Part 11 regulations.

Unfortunately, there have only been a few trials worldwide to use this method and only one in the U.S.—a phase IV study in Georgia. “People are either not aware that it’s all teed up and ready to go or they’re afraid to do something new on a new study,” Kush says. She’s in discussions with FDA to evaluate a potential partnership to perform such a study as a follow on to the eSDI initiative, from which EMA has adopted the 12 requirements for eSource.

So who should do a trial with RFD? Kush is unequivocal: “Somebody who wants to transform the clinical research process because, right now, it is really in need of transformation.”

The technology isn’t untested. Pfizer and Harvard collaborated on the ASTER study, to look at the process of pulling essentially a MedWatch adverse event form into an EHR using RFD technology. In that study, when a clinician or doctor entered a discontinued drug into the patient’s EHR, the form popped up saying: Was this drug discontinued because of an adverse event? If so, here’s the MedWatch form.

Much of the form is filled with data from the patient’s EHR. The remainder needs to be completed and sent in, a process that took less than a minute (and was done from the patient’s EHR where the doctor was already working) whereas this process via paper took over 30 minutes (which meant it did not occur). During the study, 30 doctors submitted adverse events who had never reported an AE before.

Kush believes the technology could be just as transforming for research studies. “First, it’s eSource, so you’re not transcribing data. Then you’re opening [the clinical trial process] up to investigators who wouldn’t do a trial otherwise, because you’re making it easier for them. You’re expanding the capacity of your investigators, and then you’re collecting the data in a standard format so if you go downstream...you don’t have to convert data at the back end for [regulatory] submissions. You’re building in the quality up front. These are ways to expand the investigator pool and the patient pool in the U.S.”

The timing is crucial. Although still early, EHRs are being rolled out across the country with financial incentives for doctors to adopt and use them in a meaningful way.

“We are trying to keep research on the radar as this happens,” she says. “What we’re proposing is, get a good idea of how this could work and do a study where maybe only three or four sites have EHRs...the beauty of it is you don’t have to have every site on the same equipment.”

“Every trial is precious and they need to do it right,” Kush acknowledges, “but what if they streamlined the whole process and improved the data quality?... We’d like to at least try a trial in 2011 and see if it’s got all the promise we think it does.” •