# Presentation: 198401

- caBIG CTMS Workspace F2F
- San Francisco, August 29-30, 2005
- Lab Interface SIG

## Agenda

- Introduction (15 minutes)
- Three concurrent breakouts (40 minutes)
- Units of Measure
- ebXML hub solution
- Lab-to-toxicity mapping
- Possible report back on Units of Measure (5 minutes)

## Lab SIG background

- A lab interface to clinical trials databases was identified as one of the “top four” cancer center clinical trials needs at the caBIG kick-off meeting (February 2004)
- Center need: simplify the process of building a data pipeline from clinical lab systems to clinical trials systems
- Lab data constitutes the majority of clinical trial data
- Rekeying especially time-consuming and error-prone
- caBIG need: make the data presentable in a standard, shareable, interoperable form

## caBIG Need – a Data Standard

- Identified, evaluated and selected:
- HL7v3 Clinical Trials Laboratory (CT Lab) message
- derived from the Clinical Data Interchange Standards Consortium (CDISC) LAB team’s laboratory data transmission standard
- developed to facilitate the transmission of clinical trial laboratory data from local and central laboratories to the pharmaceutical company and/or Contract Research Organization (CRO) that is managing a drug development clinical trial

## Centers’ Need – Clinical Lab Feed

- Institutional political/cultural issues
- Security, privacy concerns (real or perceived)
- Especially acute where feeds from affiliate institutions are desired
- Clinical lab systems are heterogeneous
- To get a data feed from clinical lab systems, a custom interface has to be developed at both ends
- Development and maintenance are non-trivial
- Not viable at institutions that cannot corral significant software engineering resources

## Breakout #1 – Units of Measure

- Request received from caBIG caDSR Context Administrators
- HL7v3 implies the use of Logical Observation Identifier Names and Codes (LOINC)
- most labs identify tests by internal non-standard code values; LOINC is a standard code set
- >40,000 universal identifiers for laboratory and other clinical observations
- Maintained by Regenstrief Institute (Indiana University)

## Breakout #1 – Our Input Required

- Focus of Units of Measure:
- Lab, Pharmacy, Radiology, Other Diagnostics
- Granularity of Units of Measure:
- Bulk (one general list)
- Categories of Units
- per Use Case

## Breakout #1 – What’s Next

- Supply your input today
- Bear in mind that CTMS has to interoperate beyond cancer center/NCI community
- Pharma, regulatory bodies
- A proposal will be brought to next Lab SIG call
- Solicit CTMS Workspace opinion
- Pass to VCDE Workspace
- Will become a caBIG standard

## Breakout #1 – Audience, Significance

- Those interested in standards, ontologies and the CDE curation process
- Significance beyond the lab SIG
- this will introduce the CTMS workspace to the CDE curation process
- CTMS input on other areas will surely be solicited in the future
- I would encourage you to comment on the process _as well as_ the issue at hand

## Breakout #2 – Integration Hub Solution

- Clinical lab systems are heterogeneous
- Misys, Cerner are most common in cancer centers, many others
- Most (incl. Misys, Cerner) talk HL7 v2.x
- High degree of optionality - there is no guarantee that any two lab systems will be interoperable
- To get a data feed from clinical lab systems, a custom interface has to be developed at both ends
- Development and maintenance are non-trivial

## Breakout #2 – The Problem Space

- Clinical lab systems will not go HL7v3 for several years
- Most HL7v3 lab messages are not yet ready
- Without HL7v3, a standard end-to-end solution is impossible
- Can we take centers half way and lower the burden?
- Provide a lab system integration hub solution
- ebXML suggested as a possible technology

## Breakout #2 – ebXML Questions

- What is it about ebXML that can lower the burden for cancer centers seeking to hook up heterogeneous lab systems?
- What do we need to know in order to prepare an SoW/RfP for the development of a hub for the transfer of lab data to clinical trials systems?
- How can we write the spec so it can be reusable in other areas of caBIG and beyond?
- Can we leverage the efforts of other groups that have implemented, or are implementing, ebXML solutions? In other words, how are our needs different?

## Breakout #2 – Adopter Characteristics

- What would be the characteristics and/or responsibilities for an early adopter of a pilot system?  For instance:
- Minimal cultural/political issues around access to lab data by clinical trials, e.g., access to data by affiliates
- Should be able to instantiate a clinical trials lab database around the HL7v3 standard
- Doesn’t preclude centers using commercial vendors

## Breakout #2 – Audience, Significance

- Those with an interest in software engineering and XML
- The solution can provide a model for other areas within caBIG and beyond
- Transmission of data from _any_ clinical system to a clinical trials system
- EMR, Billing, Order Entry, Decision Support, etc.
- CRIX is looking at ebXML also

## Breakout #3 – Lab-to-toxicity

- NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0, formerly Common Toxicity Criteria (CTC) v2.0, is NCI’s system for ensuring uniform grading of toxicities
- Some of the grading criteria use lab values as their basis
- absolute (e.g., above a value of N)
- relative (e.g., double the maximum normal range)
- We can take lab values and use CTC/CTCAE as algorithms to map them to toxicities automatically
- Note: a toxicity does not necessarily mean an adverse event; someone has to determine if an AE has occurred

## Breakout #3 – Issues

- Define toxicities, adverse events and serious adverse events
- Who has a system we can leverage?
- What proportion of CTC criteria map to a lab value?
- Are there other scales than CTC?
- Do we do this only for lab values downloaded automatically?
- What if there are multiple values for the same patient on the same day? What if a lab value is deleted or updated?
- Are there opportunities to provide further automation?
- Can we use baseline values to automatically determine when an adverse event is “expected”?

## Breakout #3 – Audience, Significance

- Clinical Trial Domain Experts
- caAERS looks like being the first caBIG application out of the gate
- This is a chance to add further functionality quickly
- There are existing systems to leverage
- City of Hope, MSKCC, others?

## That’s it!

- Three breakouts (upstairs):
**Units of Measure: Room 202**
**Integration hub solution: Room 261**
**Lab-to-toxicity mapping: Room 271**
- Questions?