# Presentation: 613415

## ICRi

***A Progress Report***

- David Steffen
**August 13, 2008**

## ICRi Background

**ICRi = ICR interoperability**
**Founded this year (March 7, 2008 to February 14, 2009 )**
**Has an especially inexperienced leader (me)**
**The (NCI) Plan: CTMSi, ICRi, TBPTi, IMAGi**

## The ICRi Charter

** **_**[https://gforge.nci.nih.gov/docman/index.php?group_id=512&selected_doc_group_id=3458&language_id=1](https://gforge.nci.nih.gov/docman/index.php?group_id=512&selected_doc_group_id=3458&language_id=1)**_
**“...****identify, understand, and facilitate responses to informatics needs to support integrative and translational cancer research.“**
**“...****define use cases for interoperability and identify gaps limiting interoperability.”**
**Work with the ICR Workflow and Information Representation working groups to develop a comprehensive inventory list of ICR supported projects and applications (extended to all caBIG applications.)                ****-DONE-**
**Develop a high level list of use cases, focused on but not exclusively limited to translational use cases****.  ****(Two “special” translational use cases were provided by ##.)     (October 27)**
**Develop report  identifying interoperability opportunities & gaps.**** **
**Help other groups as requested.**

## ICRi Task 1: Tool List

** **_**[https://gforge.nci.nih.gov/docman/index.php?group_id=512&selected_doc_group_id=3458&language_id=1](https://gforge.nci.nih.gov/docman/index.php?group_id=512&selected_doc_group_id=3458&language_id=1)**_**(This is a snapshot.  Being developed on Google Docs.)**
**Joint effort of ICRi, Information Representation, Work Flow**
**Did the work: Grace Stafford, Uma Chandran, Lalitha Viswanath**
**Watched: David Steffen, Kiran Keshav, Baris Suzek**
**~60-70 “tools” identified**
**~30 attributes for each tool listed (but not all used)**
**As we are beginning to work with this data, we expect to refine and add data to this spreadsheet**

## ICRi Task 2: Use Cases

**This was to be our Deliverable #2**
**However, the caBIG Leadership requested feedback on two use cases they were developing to guide future caBIG directions**

## ICRi WG Feedback on  caBIG Enterprise Use Cases

**ICRi WG Feedback on  caBIG Enterprise Use Cases**

***July 23, 2008***

## ICRi UC Review Process

- ICRi WG Lead met with ICR WS leadership.
- Written presentation and initial comments went out to ICRi participants
- Convened an ICRi teleconference. UC were reviewed in detail considering process and language
- Shared written commentary
- Convened an ICRi teleconference. UC reviewed again for process and language followed by a discussion of levels
- Written commentary

## Revised Clinical UC

**Assumptions:**
- Look at process of clinical information from a clinical trial where, based on available information, a doctor assigns a patient to particular arm of a clinical trial.
- Assume tooling exists or works with tools available in the community.
**Revised Scenario:**
- A clinician consents a patient to participate in a breast cancer clinical trial.
- Clinician sends patient for baseline imaging to radiologist.
- Patient goes to an imaging center, and gets an MR image for her breast cancer.
- Radiologist report is sent back to the clinician.
- Patient provides bio sample to the pathologist.
- Pathologist sends sample to molecular lab service.
- Lab service runs labs and sends the results back to the pathologist (FSH. IHC, GxP, SNP, et al.).
- Pathologist collates result from labs and his/her analysis of the tissue and send the pathology report back to the clinician.
- Research coordinator uses pathology report and radiology report to determine eligibility.

## Summary of Challenges

- Some of ICRi not comfortable considering caBIG tools supporting clinical care, but were for clinical research
- Others saw the distinction and wanted a clinical care component to be included with clinical research
- It was very important to ICRi to distinguish roles for each actor and use agreed upon terms to reflect accurately what each does
- ICRi is going to add a multi-center trial scenario**.**
- Levels
- Not able to be sufficiently expressive. More description and/or more levels are needed.
- Currently an incredible range of how different centers do the same tasks.

## Level Commentary- Clinical Scenario

- A clinician consents a patient to participate in a breast cancer clinical trial. (Adds at Level 0 & 1a, and several at Level 4)
- Clinician sends patient for baseline imaging to radiologist. (add at Level 0)
- Patient goes to an imaging center, and gets an MR image for her breast cancer. (Level 3) (one decrease to Level 2)
- Radiologist report is sent back to the clinician. (Level 2) (moves to Level 3, 4)
- Patient provides bio sample to the pathologist. (Level 0)
- Pathologist sends sample to molecular lab service. (Adds Level 0)
- Lab service runs labs and sends the results back to the pathologist (FSH. IHC, GxP, SNP, et al.). (Level 3) (one increase to Level 4)
- Pathologist collates result from labs and his/her analysis of the tissue and send the pathology report back to the clinician. (Level 2) (moves to Level 3 and 4)
- Research coordinator uses pathology report and radiology report to determine eligibility. (Adds at Level 0 and several at Level 4)

## Translational Use Case

**Use Case 2: “Translational Research Use Case”**
- Drew much more consensus.
- Address hypothesis generation and querying of electronic databases to assess feasibility. When IRBs are engaged varies.
- Different actors

## Revised Translational UC

- Clinical Researcher D creates a hypothesis based on bench research, clinical research, and population research (this is from survey of the literature, searches of electronic databases, and interactions with colleagues.)
- A retrospective query is performed on a research data repository (with IRB approval if necessary) to determine feasibility of the study.
- D writes a clinical protocol for validation of a biomarker as predictive of tumor shrinkage in the context of treatment and submits it to the sponsor.
- The protocol is approved and the trial is initiated.
- Patients either apply for a study or are recruited by a clinician.
- Participants are screened on the basis of eligibility.  Screening data and sample are supplied to clinic trial coordinator (coordinator) by patient for enrollment evaluation.
- Coordinator sends sample to the basic scientist for biomarker screening.
- Basic scientist sends the result of biomarker screening to the coordinator.
- Based on eligibly criteria and biomarker results, the coordinator sends the enrollment notification to patient.
- Clinical coordinator refers patient to radiologist for imaging.

## ICRi: What Else?

_**More Use Cases**_
- Based on the tools list, volunteers from the ICRi membership (e.g. the “biologists”) are developing a selection of use cases.
_**The LSD Browser**_
- We have been providing feedback for the LSD (Life Sciences Distribution) Browser Development Team

##  The End

** **