Download EHR Clinical Research Value Case Workgroup Call

EHR Clinical Research Value Case Workgroup
Summary of the conference call on Wednesday December 17th, 2008
Attendees: Jonathan Andrus, Robert Annechiarico, Kate Blenner, Perry Cohen, Elaine Collier, Jeffrey
David, Peggy Devine, Gregory Downing, Jennifer Garvin, Steven Hirschfeld, Charles Jaffe, Michael
Kahn, Linda King, Judith Kramer, Rebecca Kush, Michael Lincoln, Jessica Nadler, Armando Oliva,
Rachel Richesson
Purpose:

To finalize the Vision Document and the November Meeting Summary

To discuss the framework for the core dataset value case
SUMMARY
Key Outcomes:
The workgroup provided additional comments to finalize the Vision Document and discussed scenarios
for the prototype Value Case, data flow from EHR through clinical research system to a variety of endusers and data flow from EHR to databases or registries for observational/quality research.
Action Items:

Revisions and comments on the draft Value Case Prototype that will be distributed on or before
January 6th, 2009. Comments are requested by or before Thursday January 15th, 2009.

Members were asked to explore funding opportunities at their companies and/or the organizations
they represent on the Workgroup.
Issues:
It is important to focus on the value of healthcare and clinical research standards that support
interoperability to enhance the performance of clinical research, rather than the value of the clinical
research itself.
KEY TOPICS:
MINUTES/SUMMARY FROM 11/10/08 MEETING
Participants wanted to re-review the meeting summary/minutes as some had not seen them. These will be
reviewed at the next meeting. Others asked that work group members be listed on the meeting summaries.
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DISCUSSION OF THE 12/05/08 DRAFT VISION DOCUMENT
Judy Kramer suggested that the academic research institution needs to be mentioned specifically in the
research organization perspective. She also indicated that the payer perspective is absent from the Vision
Document. Greg Downing clarified that, in regards to clinical research, payers operate from a
perspective of the research organization. Elaine Collier asked whether there was enough specificity
about privacy and confidentiality. Michael Kahn mentioned that specifications on who should see what
data will be important, such as for IRB permissions. He also supported the concern mentioned by Dr.
Kramer about specifying that academic research institutions are key stakeholders; what is meant by
research organizations should be clarified.
Judy Kramer asked about the ultimate audience for the Vision Document, and whether this document
served more as a vision statement or a backgrounder. Greg Downing responded that the audience is
HITSP and the purpose of the document is to paint a picture of clinical research at a high level to facilitate
the HITSP standards harmonization process. The primary purpose of this is to shape in a broad context
the way in which EHRs are currently used and can be used in the future for supporting clinical research.
SUMMARY OF INFORMATION FLOW DURING CLINICAL RESEARCH
To help set the context for the discussion on the value case, Jessica Nadler introduced Linda King
and Judy Kramer, to provide a brief overview of information flow during clinical research from an
industry and academic standpoint, respectively.
Linda King mentioned that there is a flow chart in the eClinicalForum’s White Paper illustrating this data
flow. This will be distributed to the workgroup members. She started her description of the information
flow at the EDC system of the research site, which is becoming more typical as a data collection point
(although there are still sites that collect research data on paper). The site is required to maintain patient
records for the clinical study. These source records have been paper-based and necessitated manual data
entry (essentially transcription) into the EDC. The EDC submits clinical research data to a web-based
database hosted by a third party that can be accessed by the investigator and study coordinator (or there
could be a ‘thick client’ at the site). Ancillary data and data from a central reader (e.g. in the case of
ECGs or imaging) are also submitted to the database. The sponsor then reviews the data from the
database and communicates with the site if there are queries. Through the course of data
clarification/verification queries come from the sponsor back to the site through the EDC system. Finally,
once the database is locked and analyses are done, the sponsor sends reports, tables, figures and listings
from their analysis (integrated with those from other such studies) to the regulatory agency.
Michael Kahn pointed out that it is important to consider when patient identifiers are replaced by subject
IDs and who is able to link the two.
Judy Kramer said that an academic research institution sometimes follows a very similar workflow to
the industry workflow described above, but at times has a different model. Bob Annechiarico mentioned
investigator-initiated trials (IIT) as one case where they differ. Judy Kramer agreed that the IIT differs
and is often single-site, but such studies can also lead to an application for an investigational new drug.
The Clinical Trials Transformation Initiative (CTTI), however, focuses on coordination of data from
multi-site clinical research. She further described an institution-based database that can receive endpoint
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data directly from an EHR, thus obviating the need for EDC. Access to data in this fashion facilitates
site-based research, IIT and multi-site sponsored trials. Michael Kahn also pointed out that chronic
disease research would benefit from data-sharing agreements that allow long-term follow-up from disease
registries.
Peggy Devine asked who would have access to such a database. If there were access across therapeutic
areas to this type of data, it would accelerate the pace of clinical research. Judy Kramer mentioned that
clinicaltrials.gov is the nearest database to this idea, but it houses aggregate data rather than individual
data. She further stated that databases like this are proprietary when the data is collected by a private
sponsor. Mike Lincoln indicated that this speaks to the problem/existing bias of non-publication of
negative studies. Peggy Devine emphasized the utility of being able to pool data across trials. Linda
King said that the ability to pool data is entirely dependent on harmonized standards. Judy Kramer
mentioned the Sentinel Initiative, which is not a single database, but is aggregated private data held by
numerous different organizations.
DISCUSSION OF THE VALUE CASE
Greg Downing reviewed the prioritization activities that the group engaged in at its first meeting and that
the top priority was the identification of a core dataset of elements in EHR that are common to the
majority of clinical research studies. In this regard, not all of the points raised in the vision document are
captured in this particular value case. The broad needs of clinical research will require additional work on
other priorities such as patient enrollment/notification of clinical trial eligibility, and adverse events.
Judy Kramer asked that payers be added as a stakeholder in the Value Case. Greg Downing suggested
that the payers often function as CRO or sponsor, in regard to information flow. Elaine Collier said that
the Centers for Medicare & Medicaid Services need the results of clinical research, but cannot fund it.
Michael Kahn asked that the core dataset also include information about IRB permissions for the use of
the specific entry. Elaine Collier indicated that the NIH and other Federal funders should be a
stakeholder, as they are not regulatory agencies. Peggy Devine asked that there be an ability to determine
which studies have ended with negative results, but not been published.
Becky Kush asked that we focus our discussion on Core Dataset Value Case.
Rachel Richesson asked whether there was a description of how study information is integrated back into
the EHR. Greg Downing said that there have been previous HITSP Use Cases addressing quality and
performance that illustrate this workflow. This Value Case can leverage previous work from these
existing Use Cases (Biosurveillance, Best Practices, etc.)
Elaine Collier asked what the substance use domain encompassed. Becky Kush defined it as substances
such as tobacco and alcohol. The domains mentioned in the Value Case Outline leverage existing
standards and provide a foundation for the other priority areas that were discussed at the November
meeting. Elaine Collier mentioned that the standards for concomitant medications may be problematic.
However, there was general agreement that the list of domains in the Value Case outline would be a good
set as a starting point (the core set), since these will leverage standards work that has already been done.
There was a brief discussion of the value piece of the Value Case and it was decided that this is best
discussed after a draft of the Value Case has been distributed. Becky Kush commented that the
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individual calls that Jessica has been having with the Workgroup members have been providing very
good information for this session.
Bob Annechiarico suggested that another stakeholder could be treatment organizations, such as affiliate
health care and hospitals. Perry Cohen added that this could include any number of community-based
health providers and support groups, even groups like Meals On Wheels.
Greg Downing suggested we move on to the scenarios in the Value Case Outline and indicated that these
needed to capture the value that will be provided to clinical research by the implementation of
harmonized standards around a Core Dataset. Jessica Nadler described two scenarios for the Value Case
(to replace those in the initial outline) that capture the two main types of workflow that have been
discussed on this call, as well as some of the calls with individual group members. First, the scenario
outlined by Linda King earlier in the call, where data moves from EHR to a clinical research system to a
number of downstream users (sponsor, regulatory agency, IRB, biosurveillance, etc.). Second, the
workflow brought up by Michael Kahn where data moves from EHR to a registry or database that
facilitates observational and quality research, in addition to the aforementioned research into chronic
diseases.
TIMELINE
Becky Kush laid out a timeline for the production of the Value Case to give to the use case team by early
February. The draft of the Value Case will be distributed to the Workgroup for revision on or before
January 6th. We will also need to schedule a 90 minute call for either January 15 th or 16th to discuss the
Value Case.
Becky Kush also gave an update on her fundraising efforts for the HITSP process for this Value Case.
She has several commitments, but given the poor economy, donors are giving at a lower level than they
may have a year ago. She asked that Workgroup members explore possible funds through their
companies and the organizations they represent as members of the HER Clinical Research Value Case
Workgroup. Mike Lincoln reiterated that HITSP is committed to this Value Case.
Becky Kush thanked the Workgroup for their participation and closed the call.
APPENDIX
1. Final Draft of November Meeting Summary
2. Final Draft of Vision Document
3. Outline of Prototype Value Case
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