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9 Jul 2012

For those of you who were unable to attend the DIA 2012 Annual Meeting in Philadelphia at the end of June (or those of you who may have missed this session), there was an excellent set of presentations from FDA representatives. Here is my summary; I would welcome additions and/or comments.

 

The session was chaired by Dr. Chuck Cooper. Mary Ann Slack spoke first on the topic of CDER Data Standards. She opened: “We cannot improve efficiency or innovate without standards.” CDER is working, with other FDA centers, on end-to-end standards to support a standards-based review environment. They have posted a list of therapeutic area standards that they would like to have developed, to add to the existing standards (which pertain to all research studies); they have also created a ‘notional timeline’ for these. However, she stated clearly that FDA should not drive the standards development; CDISC and the Critical Path Institute, with patient advocacy groups, are working on these, with nine of the therapeutic area standards already in progress. “CDISC, C-Path and FDA collaborate constantly.” (See the CDISC-C-Path Press Release from 23 June 2012 about CFAST).

 

Questions and comments are welcome here!  

11 Jun 2012

In early May, Bron Kisler (CDISC VP, Strategic Initiatives) and I
spent 5 days (Saturday through Wednesday) at JIC and ISO meetings in
Vancouver, Canada---okay, there are far worse places to spend a weekend
working, and the food there was wonderful, especially since the locals
were talking us to their favorite places. Most importantly, there were
important goals to accomplish for CDISC: 1) to enhance the governance
of the JIC and 2) to get BRIDG through the entire process to become an
ISO/CEN standard. I will provide a bit more detail on each of these,
but suffice it to say that it was a productive week and we are indebted
to many wonderful CDISC friends from around the globe.

 

The Joint Initiative Council (JIC) began as a group of
3 SDOs, i.e. Standards Developing Organizations, namely ISO, CEN and
HL7. They added CDISC (after a 6 month probation period) when we proved
to be 'good citizens' working with the other three, particularly in
areas that relate to clinical research. Two more SDOs were then
included-GS 1 and IHTSDO. After leadership from HL7 and CEN, CDISC was
asked to Chair the JIC, and Bron has filled this role for over a year
now.

11 Jun 2012

The Learning Health System Summit took place on 17-18 May at the
National Press Club in Washington, DC. It was the culmination of
intense planning that occurred via phone several times monthly from the
time of the CDISC Interchange in October 2011 (and even before, but that
is when CDISC learned about this initiative). Dr. Charles Friedman
gave a keynote address on his vision of the Learning Health System (LHS)
at the CDISC International Interchange in Baltimore in October 2011 and
spoke afterwards with then Board Chair, Dr. Frank Rockhold and myself
about his plans to take this concept forward. [He had recently left his
position as chief scientist in the Office of the National Coordinator to
assume a position at the University of Michigan.] Chuck has published
about the LHS in Science Translational Medicine (10 November 2010);
directly aligned with the CDISC Vision, the LHS focuses on the fact that
research data comes from healthcare and, in turn, should inform
clinical care decisions. This cycle is said to take 17 years currently
(for research results to end up in clinical decision support). As Chuck
would say, we would like to see this go to 17 months, weeks or minutes!

 

The opportunity that took place last month was
afforded by Mr. Joe Kanter of the Kanter Family Foundation and Kanter
Health. He funded the LHS Summit; the Summit Planning Committee
(including Frank Rockhold and myself) and was led by Dr. Friedman,
assisted by Josh Rubin (Executive Director of Kanter Family Foundation)
and students from the University of Michigan.

17 May 2012

David Moner, Clinical Trials Powered by Electronic Health Records

 

David Moner of Universitat Politecnica de Valencia was first to present during the Electronic Health Record (EHR) session on the second day of the European Interchange. Mr. Moner began his presentation by summarizing the current status of EHR use in the healthcare industry; he detailed that, while a great deal of effort and investment has been put toward the adoption of EHR systems, and although this has benefitted healthcare delivery, so far it has not been as clearly beneficial for clinical research. Specifically, the concept of EHR data reuse remains an unresolved issue.  Read More.

 

Kiyoteru Takenouchi, Japanese Sentinel and MIHARI Project

 

Kiyoteru Takenouchi of CMIC was next introduced, and began his discussion by describing how the EHR is currently in use in Japan. At this time, 90% of large hospitals in Japan have Computerized Physician’s Order Entry (CPOE). The PMDA’s (Japan’s FDA) MIHARI Project focuses on having four working groups for each information source: 1) reimbursement claims and Diagnosis Procedure Combination (DPC)/Diagnosis Related Group (DRG), 2) hospital information system, 3) spontaneous adverse events reported to PMDA, and 4) post market surveillance collected by pharmaceutical companies. Data is changed to a standard format when it is sent to storage, which allows reuse for many purposes, such as referrals to other clinics and hospitals.  Read More.

 

 

Pierre-Yves Lastic, Report from the EHR4CR Project

 

Pierre-Yves Lastic of Sanofi Aventis followed Mr. Takenouchi, and presented on the Innovative Medicine Initiative’s (IMI) EHR4CR Project, a four-year project (2011-14) with a budget of over 16M euros with the objective of promoting the wide-scale reuse of EHR data to accelerate regulated clinical trials across Europe (although now that the FDA is a part of the advisory committee this is anticipated to expand). The project works with 10 pharmaceutical companies, 22 public partners from academia, hospitals and SMEs (including CDISC), and five subcontractors. To date, this project is one of the largest public-private partnerships working on reuse of EHR data for clinical research. Reuse of EHR data offers opportunities to advance medical research, improve healthcare and enhance patient safety. 

16 May 2012

Presented by Sonia Araujo, Medidata Solutions
and Gary Walker, Quintiles


“The idea of the CDASH E2B project initiated ten years ago, but just
until 2010 it started taking effect” said Barry Burnstead, a member of
the CDISC European Coordinating Committee (E3C) and chair of the CDASH
session at the CDISC European Interchange in Stockholm.

 

Sonia Araujo of Medidata was the first presenter on the CDASH-E2B session

 

Sonia Araujo declared that the purpose of the
project is to identify and describe the International Conference on
Harmonization (ICH) E2B fields that are collected at investigational
sites for serious adverse event reporting. Hence, a CDASH-E2B team was
formed by CDISC and led by Rhonda Facile.

 

Members of the CDASH E2B group represent a good cross section from the
healthcare industry coming from both Europe and U.S.A. The E2B group
consists of representatives of biopharmaceutical companies along with
software vendors, CRO representatives, sponsor companies as well as
independent organizations such as the U.S. Office for Policy.

8 May 2012

FDA Presentation at the CDISC European Interchange
We were very fortunate to have Dr. Chuck Cooper, FDA/CDER, join us at
the CDISC European Interchange last month! (Mary Ann Slack, also of
FDA, had also planned to present in this session; however, she was
unable to travel to Stockholm at the last minute. Dr. Cooper combined
her slides with his and spoke for both of them.) As the E3C Chair,
Pierre-Yves Lastic, commented…the attendees were very pleased to have an
FDA representative there ‘in flesh and blood’ to talk with them and

8 May 2012

Novo Nordisk Presentation during the CDISC Interchange Europe 2012


Gitte Frausing of Novo Nordisk presented on her CDISC SEND experience
during the CDISC European Interchange in Stockholm on 18-19 April. The
focus of her presentation was on lessons learned from the FDA-SEND
Phase 2 Pilot, in which Novo Nordisk participated. The value of a close
collaboration among the SEND team, the CDISC Terminology team and the
FDA was readily apparent from this presentation.

 

Gitte described how different terms with varied
definitions may cause inconsistencies and inaccurate results within the
non-clinical analysis. She illustrated her point of view with some
examples of inconsistencies within the area of microscopic findings: one
of the findings showed a liver having a 3 millimeter pale area with
surrounding hemorrhage, which is actually considered two findings in
SEND and should not be included in the same record. Gitte also
mentioned that having no place to incorporate certain data in the SEND
domains caused loss of information due to the lack of standardization in
the data capture phase. This was one of the ‘lessons learned’ that the
FDA agency has found during their analysis of the submitted data.

 

Another example Ms. Frausing provided was that FDA asked Novo Nordisk to
test the terminology for the severity variable in SEND standard; the
outcome was to ensure the validity of the terminology already created by
the SEND terminology team.

 

8 May 2012

Still resonating for me are quotes from ACRO Executive Director, Dr.
Doug Peddicord, at a recent FDA public hearing entitled "Modernizing the
Regulation of Clinical Trials and Approaches to Good Clinical
Practice." On behalf of the Association of Clinical Research
Organizations (ACRO), Dr. Peddicord proposed a Chief Innovation Officer
for FDA, among other recommendations.

 

Cited below is a segment from the ACRO press release on this topic:

 

Peddicord expressed concern about the slow progress
that has been made since the release of the FDA's "Critical Path"
whitepaper in 2004. He noted that while some FDA-supported efforts, such
as the C-Path Institute and the Clinical Data Interchange Standards
Consortium (CDISC) have had success developing tools to advance drug
development, other efforts have fallen short. Notably, Peddicord
singled-out the Clinical Trials Transformation Initiative (CTTI).

 

"While CTTI is well-intentioned, it has not taken on
projects that have the potential to be 'transformative,’" said
Peddicord. "Every effort at innovation that the FDA supports, directly
or through the funding of public-private collaborations, should be
measured against three objectives: does it make the drug development
process faster, cheaper or more productive."

 

8 May 2012

“Ask the Expert” session of the CDISC European Interchange 2012 was
quite remarkable. Stimulating questions related to the CDISC
achievements and other issues grabbed the attention of the audience. In
fact, this was arguably the best session of 2012 CDISC Interchange
since the two excellent Plenary Sessions had not allowed time for
Q&A, while this session gave the audience plenty of opportunity to
ask many of these Plenary speakers about issues they really wanted to
understand.

 

The panel was formed of international experts in the
healthcare/research industry: Charles Cooper of FDA, Bernard De Bono of
the European Bioinformatics Institute, Bron Kisler and Wayne Kubick of
CDISC and Pierre-Yves Lastic of Sanofi and the E3C answered inquiries
from the attendees.

 

 

1. Does the FDA expect the community to use the latest SDTM Implementation Guide and how is this going to be approached?

 

8 May 2012

I had the opportunity to listen for the first three presentations of
Session 5 at the 2012 Europe Interchange in Stockholm. Dr. Philippe
Verplancke of X-Clinical (and also a CDISC ODM Instructor) chaired this
Session, which centered around ODM and XML.

 

Jozef Aerts, Multipurpose Usage of the New “Study
Design Model in XML” (SDM-XML)
Jozef Aerts of University of Applied Sciences FH Joanneum, Vienna,
Austria presented on the multipurpose usage of the new Study Design
Model in XML (SDM-XML)