Info & Opinion
June 26, 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
Let’s be as polite about this as possible. The American physician has not been keenly interested in using computers outside of a reimbursement context. Many doctors in the U.S. remain perplexed about whether computers in their exam rooms and offices are worth the investment. Some doctors feel electronic health record (EHR) systems cost them money and waste time.
Our new president and a docile Congress are about to adjust that calculus. To the tune of perhaps $20 billion, Barack Obama is planning to subsidize EHR purchases. It might represent a mind-boggling increase of one thousand fold over the funding unsuccessfully sought by the last administration, which also believed in greater investment in medical IT infrastructure. The goal: to eliminate unneeded care and gather data about existing care.
Of course, even without federal encouragement, many physician practices and hospitals are splurging on EHRs on their own. (ClinPage’s own internist spends most of his time looking at his EHR screen, not our aging body.) Many types of EHR have arisen to meet the demands of physicians. The industry is booming. There are systems to electronically generate lab tests, prescriptions. There are systems for specific therapeutic areas. There are systems for big practices and small ones.
Could these new systems be robust and ubiquitous enough to help recruit physicians and patients into industry-sponsored research? If so, when? Today? In 2012? Some of the federal planning for EHR usage projects that all doctors will have a minimal EHR by the middle of the next decade. Will any research-oriented physicians ever be bold enough to stamp their feet and say “I’m not participating in your trial until you connect your system to the one I use” ?
Beyond that, to what extent do research-oriented technologies and processes need to be reengineered to exchange data with EHRs? Will EHR vendors see EDC as a sweet, juicy little appetizer to be swallowed whole? Or as the grim bag of turkey organs tucked into every bird—giblets that theoretically could be used in the cooking process, but probably won’t be?
Last week, the Society for Clinical Data Management did a webinar on the coming role of the EHR in the research process. Your correspondent was on the call. Our role was to serve as a moderator to allow the brilliance of an EHR executive, Steve Schwartz of Allscripts, to shine. Schwartz is wiser than most when it comes to discussing the potential synergies between the EHR and EDC realms.
On this week’s webinar (on Thursday at noon eastern time) Schwartz will be back, and there will be a new guest to discuss the EDC industry’s perspective on the issue. Anthony Costello is a past chair of the SCDM and a former executive at Nextrials, an EDC firm in the San Francisco area. The goal this week is to explore the nitty-gritty details of how to connect EHR and EDC systems.
Here’s what’s clear to us already.
1. The technical and regulatory work to connect EHRs and EDC systems is more advanced than most people recognize. The soil has been tilled. In isolated pilot projects, at this trade show or that one, EDC and EHR systems have been easily connected. HIPAA-regulated EHR data pipes can be connected to 21 CFR Part 11-regulated data pipes. It can be done.
The rules are coming along, too. One organization to watch is HITSP, a public-private hybrid. Within the past few weeks, with this notice in the Federal Register, the U.S. government finalized guidelines for health care interoperability. Some 600 organizations participated, donating 23,000 hours of labor. Here’s some background from the notice: “Under a contract with the Department of Health and Human Services, the American National Standards Institute (ANSI) established HITSP following a neutral and inclusive governance model. The HITSP standards harmonization process was built by vendors, standards development organizations (SDOs), consumers, payers, providers, and other sectors of the industry.”
If you want to accelerate EDC-EHR interoperability research, throw a little money in the general direction of CDISC or Landen Bain. They have been worrying about this stuff longer than anyone. They have never seen the pharmaceutical industry’s research systems as islands (even if that is how most sponsors build them).
2. There is a massive upside here. There is no question the EHR would be viewed as a quantum improvement over EDC to many of the sites now doing research. Having a single user interface, used all day, would be better for clinical research associates and investigators than having to learn the nuances of umpteen EDC systems. If an EHR system could populate the basic demographic data and vital signs into 21 CFR Part 11-validated systems, site workloads will be lightened. For that reason alone, the pharmaceutical industry must seriously explore the usage of EHR: the technology could keep some investigators in the industry in the U.S.
3. We ain’t there yet. Even our cursory and typically breezy journalistic “research” turned up no fewer than three organizations purporting to certify standards in the EHR industry. We have no idea which group matters most. Connecting one EHR system to one EDC system at a trade show is an important first step. Connecting any EHR system to any EDC system is what is going to be necessary. No sponsor of a clinical trial would enjoy getting a message like: We’d love to participate in your trial, but your electronic data capture system won’t talk to our EHR system.
Full interoperability will depend, in part, on two separate industries—EDC and EHR—reorienting themselves toward each other. We cannot think of any historical precedent for such an alignment. Generally, industries devour each other. What would be needed, in very simple language, is an EDC system that can interoperate with any EHR system, and an EHR system that can interoperate with any EDC system. Right now, those don’t exist. It’s not clear that the business case exists for each industry to make those changes.
4. If such systems were built, the contract research industry might be more adversely impacted than the EDC industry. EHRs could overturn the existing approach to identifying patients and investigators in clinical trials. Today, as readers know, that process is an ad hoc one. For every project, every time out of the gate, each team locates a new, unique network of physician-scientists. Those investigators get a spiffy, custom-built system that is used for 12-36 months, and then shut down. This makes perfect sense to most of the readers of this website. It works well enough. But in a world in which clinical trials are gathering data from EHR systems, it might be possible to find all of the U.S. sites through a few clicks of the mouse. Over the next decade or two, it’s possible EDC systems would remain mission-critical systems. Or they could morph into divisions of much larger EHR companies, ceasing to exist as separate entities.
5. The international landscape for EHR-EDC integration is murky. EHRs are an outgrowth of a fragmented, Balkanized health care system in the U.S. It’s not clear how easily single-payor systems in other countries could be connected to the EHR systems used by the pharmaceutical industry. Even if the technical details could be solved, politics could be an issue in some countries. My fellow Ukrainians, our nation’s health records will now all be shared with the pharmaceutical industry. Are you OK with that? Theoretical privacy protections such as deidentification will not matter unless the industry’s larger reputation has been repaired.
6. It is not clear if enough EHR vendors will care about delivering systems for industry-sponsored research. To companies like GE and Cerner, clinical trials are a negligible market. A yawn. A lack of interest on the part of EHR suppliers to provide clinical trial-related functionality will preserve the status quo. Complying with HIPAA is a challenge unto itself, and EHR legal teams may take a look at 21 CFR Part 11 and say, “Um, no thank you.”
Another scenario might work in the industry’s favor. EHRs could change the economics of physician practices. Support from clinical trials has transformed the economic picture for more than one Allscripts customer. In one case, described in this CDISC PDF document, the Greenway EHR system populated an impressive 75 percent of the data needed for a trial for which Outcome provided the underlying EDC technology. For those doctors, the reduced workload in an era of EHRs provided a tipping point, leading them to participate in industry-sponsored research for the first time.
The EHR-EDC synergies could be a golden marketing opportunity for any participants in the EHR industry smart enough to seize them. Especially in the current economic climate. That argument goes something like this. Investments in EHR technology will keep massive R&D budgets and thousands of high-paying jobs in the dear old U.S.A. Perhaps the new guy in the White House is onto something after all.