Info & Opinion
July 21, 2019
With news about big data, Aetna, Covance, GNS, Scrip, Quintiles, PPD, Icon, BioClinica, Merge, Medidata and GSK.
With news about FDA, CTMS, PMG Research, Inclinix, EMA, Hemofarm, Parexel and the Korea Drug Development Fund
David Underwood of Quanticate says some firms are giving short shrift to the basics of clinical trials
With news about Roche, Quintiles, Allscripts, Janssen, SGS, Oracle, TriReme, OpenClinica and FDA
Most ClinPage readers have been to a conference where someone stands up and says, "Back in 1985, my company was doing some interesting things with computer punch cards. It was very close to what electronic data capture (EDC) became. We decided to unplug our system after a few years, but it worked well—better, in some ways, than today's EDC systems."
Over the years, your correspondent has heard variations on that message about 25 times. In the end, it took a decade or two to work out the kinks in EDC. Today, in 2009, the technology is finally a real industry.
The prospect of electronic health records (EHR) in the clinical trial environment thus presents something that historians don't see every day. There's a technical term for it: a do-over.
Will the industry begin experimenting with EHRs at the same pace, and with the same deliberate reserve, that it explored EDC? Or will it be different this time? Just as Japanese electronics companies faced first the VCR format issue and then the high-definition DVD format issue, pharma is poised to confront a second technology soon after it grudgingly accepted a similar tool.
The difference this time is that the two technologies will probably have to sync up. To become interdependent. Neither will be able to stand on its own. For those who traffic in such things, there are rumors of interesting EHR-EDC combinations at the upcoming Drug Information Association (DIA) meeting in San Diego.
Some observers believe EHRs could enter the landscape quickly, faster than EDC. They take heart that a new White House, confronting a shattered economy, is planning to spend ten or fifteen times the annual FDA budget on EHR subsidies for technology-averse hospitals and physicians who, we are assured, cannot afford computers without government help.
Catherine Celingant is a case in point. She's senior director, medical systems innovative technologies at the Millennium division of Takeda. Celingant is based in Boston and has been kind enough to point out a few initiatives from the Pharmaceutical Research and Manufacturers of America (PhRMA), none of which had crossed our desk. It's clear that the industry would prefer not to let the evolution of clinical trial ready EHR systems happen haphazardly. The sponsor community wants its vendors to link their EDC systems to the new embryonic EHRs that Washington will pay for.
Celingant reminded us about international standards or regulatory organizations trying to make EHR-EDC convergence happen. HL7 invited PhRMA's participation. EuroRec is getting involved. Other participants include HITSP, ANSI, CCHIT and CDISC. Which is in the driver's seat? That's not yet clear.
Celingant herself is part of a special PhRMA task force, the Electronic Health Records for Clinical Research functional profile project. It's a joint effort with the Eclinical Forum. The PhRMA-Eclinical Forum effort intends to help the industry shape and understand the potential of EHRs in clinical trials.
Crucial details still need to be worked out. One non-peripheral matter is whether the FDA will nudge the industry toward EHR usage and standards, as it helped advance the data standards of CDISC. Another issue: how EHR systems should supply so-called "source" data that will comply with all the layers of regulation affecting the clinical trial universe. The last thing the industry wants is an abundance of EHR systems that create legal or IT problems for pharmaceutical research.
Celingant is passionate and persuasive that the industry can learn about EHR systems and potentially expand their role into clinical trials. "There is a beautiful opportunity," she says.
Some EDC suppliers are worried about EHR systems displacing them. EHR vendors, for their part, may think the comparatively tiny clinical trials market is too small to bother with. Celingant believes the two technologies could work in harmony and that EHRs might never disrupt EDC suppliers at all. There simply might be a bit less visibility to EDC systems if electronic case report forms (CRF) started to appear inside EHR systems instead.
In general, Celingant says, the EHR-EDC convergence concept was fairly abstract until Landen Bain and others were able to demonstrate CRFs inside an EHR. (Here's a ClinPage article and podcast on Bain's efforts.) Then people in the industry could glimpse something transformative. That's the ability to no longer train investigative sites to use an endless array of different technologies in every trial.
For those who see EHR-EDC convergence as the holy grail, it would allow sites to use the same EHR systems with which they are already familiar. Reducing the hassle factor of industry trials, in turn, could significantly expand the numbers of U.S. sites willing to participate in commercial research. There is a lot to like here from a job-creation and national economic development perspective.
Having said that, the incentives for EHR and EDC vendors to work together remain murky. Will any sponsors ever require their colleagues to use EHR-friendly EDC systems? Beyond that, the technical and legal issues are nontrivial. Celingant does not shy away from the knottiest questions. "How can we clean it?" she says of source data. "Under what circumstances would we clean it?" Such things are being worked out.
The PhRMA team has already come up with a handy checklist to help EHR suppliers and clinical trial technology vendors determine if their combined systems can legally supply source data for clinical trials. (It's at the end of this PDF from the PhRMA task force.) Each item in the checklist has an associated U.S. or European regulation requiring it. The PhRMA-Eclinical Forum team didn't just base its checklist on personal preferences.
In some cases, we were interested to see that the checklist references the case report guidelines from CDISC. At the risk of stating the obvious, the pharmaceutical industry's past efforts to use data standards should position it well to interoperate with health care systems. Why? Because the people at CDISC have been thinking about connections between clinical trials and health care since the inception of the organization. For years.
Still, we wonder whether some of the items on the PhRMA checklist could be challenging for firms new to clinical trials. Here are two examples from page 14 of the checklist: "System will have an audit trail to include recording date/time/author of any data creation, change, or deletion" and "System will not allow new audit trail information to overwrite existing (previous) information."
Not being an EHR expert, your correspondent has no idea if EHR system providers would be able to glance at that language and say: "No big deal, our software has done that for years." Or, instead, would they mutter, "Never! That is impossible and out of the question!"
A lot is hanging on the answers to those questions. They could determine whether large numbers of EDC and EHR systems can be linked with each other with relative ease—or whether such connections are a bit more fraught and tenuous.