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Domain Expert F2F Meeting

Domain Expert F2F Meeting. January 19 & 20, 2011. caBIG® Clinical Information Suite. Patient Trial Finder. Patient Trial Finder Review. Use Cases & Descriptions : Identify Scope of Analysis Discuss Use Case Relationships Confirm Descriptions and Conditions Primary Event Flow

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Domain Expert F2F Meeting

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  1. Domain Expert F2F Meeting January 19 & 20, 2011

  2. caBIG® Clinical Information Suite Patient Trial Finder

  3. Patient Trial Finder Review Use Cases & Descriptions : • Identify Scope of Analysis • Discuss Use Case Relationships • Confirm Descriptions and Conditions • Primary Event Flow • Requirements • Review & Confirm

  4. This diagram shows all the use cases and actors touched on in our discussions and research. The actors here represent roles. The Information Source Role (system role) represents the collection of registered trials including those which a site has approval to offer. The boundary (PatientTrialFinder) shows the scope of our topic by differentiating those use cases for which we believe our reference implementation should be supporting.

  5. Diagram - Select Clinical Trial • 1.07.04 Manual search, often for a single known trial. • 1.07.03 Exhaustive search, retrieving all trials that fit the sum of currently known medical data for the patient. • 1.07.01 The act of comparing a particular trial to a particular set of patient data (ranking) • 1.07.02 Organizing the set of all possible trials by various criteria (type, treatment, distance, etc) Note: Numbering is just for identification and not meant to represent sequence.

  6. Diagram - Select Clinical Trial

  7. Diagram- Select Clinical Trial «actor» ACT10.01: Information 1. Source PTF-UC01.07.04 Retrieve single trial detail 2. ACT02.01: Health 3. Care Provider PTF-UC01.07.01 Compare PTF-UC01.07.03 Retrieve trial and patient criteria «include» list of trial detail 4. «extend» Note: Numbering is just for identification and not meant to represent sequence. PTF-UC01.07.02 Organize results ACT03.01: Patient

  8. 1. Retrieve Single Trial Detail • The title and/or unique identifier of the trial is known • Unique keyword is known • The details of a specific trial are sought • Unique identifiers are attributed to trials in several schemes. • Clinical Trials.gov (e.g. NCT00032890) • National Cancer Institute ( e.g. NCI-02-C-0052, discontinued as registry in 2010) • Sponsor-assigned unique ID (e.g. Merck-023) • US NIH Grant/Contract Award Number (e.g. R01DA013131) • European Union Drug Regulatory Authorities Clinical Trial System • Universal Trial Number (WHO International Clinical Trials Registry Platform) The aim of the UTN is to facilitate the unambiguous identification of clinical trials. The UTN is not a registration number. • Pre-conditions: • A unique trial identifier can be specified • Post-conditions: • Trial details are provided «actor» ACT10.01: Information 1. Source PTF-UC01.07.04 Retrieve single trial detail ACT02.01: Health Care Provider

  9. 2. Retrieve List of Trial Detail • The list of appropriate trials is formed by matching patient medical data with trial treatment and inclusion/exclusion specifications. As more medical data is collected, the list may be refined. • Pre-requisites: • A repository of clinical trials is available to search • Post-conditions: • A list (possibly empty) of clinical trials for which the patient may qualify is provided • The query used to create the list is available to inspect and/or save. 2. 3. PTF-UC01.07.01 Compare PTF-UC01.07.03 Retrieve trial and patient criteria «include» ACT02.01: Health list of trial detail Care Provider 4. «extend» PTF-UC01.07.02 Organize results

  10. 3. Compare Trial and Patient Criteria • To match any trial with the given medical data of a patient, a consideration of the trial criteria has to be assessed for similarity to the patient medical profile • Pre-conditions: • A description of the trial inclusion/exclusion criteria is available • A description of the trial protocol is available • A medical history of the patient is available • Any current treatment plan for the patient is available • Post-conditions: • The trial is recommended or not. • If recommended, some rank ordering is assigned. «actor» ACT10.01: Information Source PTF-UC01.07.01 Compare 3. PTF-UC01.07.03 Retrieve trial and patient criteria «include» list of trial detail

  11. 4. Organize Results • The list of appropriate clinical trials can be arranged by ordinality of one or more attribute value sets. Phase, size, (alphabetical) treatment, costs. • Pre-condition: • A collection of trials in some initial order • Post-condition: • A collection of trials presented in order by selected attribute 2. PTF-UC01.07.03 Retrieve list of trial detail 4. «extend» PTF-UC01.07.02 Organize results

  12. Event Flow – Search Clinical Trials Consider trial Collect the personal and medical information for the patient. This should include any current treatment or proposed treatment. [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no search Interpret patient data in terms translatable to trial attributes. PTF-AM01.02 Examine patient record Consider all the trials in collection and retrieve those matching the query attributes. PTF-AM01.03 Retrieve matching trials The list of trial references are organized by goodness of fit. Indicate those trials that are already offered by the practice. PTF-AM01.04 Organize matching trials Trial found

  13. Requirement Review Consider trial FRQ-PTF-026 - The system shall automatically initiate a query for clinical trials when the minimal required patient information is captured. [insufficient data] Minimal patient info has been established as: -Patient Demographic information. PTF-AM01.01 INF-PTF-032 - The system shall allow the user to configure the minimal set of patient data used to automatically trigger a clinical trial search. Collect patient information [sufficient data] no search PTF-AM01.02 Examine patient record FRQ-PTF-033 - The system shall provide for ad-hoc (manual) search where clinical trial attributes can be manually entered. PTF-AM01.03 Retrieve matching trials PTF-AM01.04 INF-PTF-034 - The system shall provide the ability to view clinical trial attributes automatically generated from patient data Organize matching trials Trial found

  14. Requirement Review –Part 2 Consider trial [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no search PTF-AM01.02 Examine patient record • The alert may be one of: • visual cue presented with patient data • email to designated health care provider FRQ-PTF-023 - The system shall generate an alert if a patient matches one or more clinical studies. PTF-AM01.03 Retrieve matching trials PTF-AM01.04 Organize matching trials Trial found

  15. Requirement Review- Part 3 FRQ-PTF-002 - The system shall indicate the total number of matching trials for any submitted query FRQ-PTF-003 - The system shall provide for the sorting of trials by distance from specified zip code FRQ-PTF-004 - The system shall provide for the sorting of trials by sponsor Consider trial [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no An intervention can be drugs, devices, procedures, or vaccines used in a trial. FRQ-PTF-006 - The system shall provide for the sorting of trials by trial type. search PTF-AM01.02 Examine patient record FRQ-PTF-007 - The system shall provide for the categorization of trial qualification under NCD. (National Coverage Decision) for routine costs in clinical trials (310.1 – CMS guideline). PTF-AM01.03 Retrieve matching trials FRQ-PTF-010 - The system shall provide estimates of out-of-pocket costs for patient participation in a clinical trial. PTF-AM01.04 Organize matching trials Trial found

  16. Requirements Review – Part 3A Treatment setting refers to the intent of treatment e.g. curative, supportive, correlative (correllation?), pedigree, etc FRQ-PTF-012 - The system shall provide a list of offered trials sorted first by diagnosis, then by treatment setting Consider trial The business rules would account for - site resources required by trial protocol - regulatory effort to participation - coverage estimate given current patient population FRQ-PTF-017 - The system shall provide for business rules that can determine an estimate of cost to site for trial participation [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no search FRQ-PTF-019 - The system shall have the capability to aggregate trial descriptions from multiple sites PTF-AM01.02 Examine patient record FRQ-PTF-020 - The system shall have the capability to distinguish trials offered by the practice already from those that are not. The local trial repository is typically those trials for which the site has already gained approval to run PTF-AM01.03 Retrieve matching trials FRQ-PTF-029 - For every item in result set, system shall provide reference to entries additional entries in other repository sites that offer additional content PTF-AM01.04 Organize matching trials

  17. Requirements Review – Part 3b We need to assemble list of important trial aspects to make this testable. Common complaints with existing search sites is that not enough information is returned to typically make a decision The specific content inventory: o inclusion criteria o exclusion criteria o consent forms o protocol synopsis o sites administered o investigators INF-PTF-022 - The system shall provide a detailed and succinct description of most useful trial aspects (decisionable content) Consider trial PTF-AM01.01 Collect patient information [sufficient data] no search PTF-AM01.02 Examine patient record INF-PTF-025 - The system shall provide the ability to capture and display at least two protocol/clinical trial identifiers associated with a patient's treatment regimen. (this is referring to different identifiers for the same trial. A functional requirement for ONC, but could be cast as informational requirement as part of clinical trial description that must be retrieved and/or queried on PTF-AM01.03 Retrieve matching trials PTF-AM01.04 Organize matching trials

  18. Requirements Review – Part 4a The actor initiating the retrieval of the trial information may know the trial by an an id other than the unique id used by clinical trials site. Match the trial name and/or unique identifier or keyword(s) Obtain the details of trial eligibility criteria, protocol, and consent Review the trial description and other details

  19. Requirements Review – Part 4b FRQ-PTF-018 - The system shall have the capability for natural language query formulation FRQ-PTF-030 - The system shall allow for manual search in addition to automatic search FRQ-PTF-009 - The system shall provide access to the protocol synopsis for a particular trial

  20. Requirements Review – Part 5a Review the more detailed full-study synopsis and the detailed description of the methodology, investigators, locations and other specifics of the trial For each trial, determine a measure of how close it matches the medical information and personal preferences To match any trial with the given medical data of a patient, a consideration of the trial criteria has to be assessed for similarity to the patient medical profile Provide additional information to refine search

  21. Requirements Review – Part 5b FRQ-PTF-014 - The system shall compare for match any new trial offered against all existing patients14, FRQ-PTF-015 - The system shall compare for match any new patient against all existing trials FRQ-PTF-028 - System shall use clinicaltrials.gov as primary source FRQ-PTF-001 - The system shall provide for the ability to label, store and retrieve any formulated query FRQ-PTF-016 - The system shall possess the capability for encoding of patient data and trial eligibility in a shared, unambiguous semantic framework FRQ-PTF-013 - The system shall aid construction of a trial query by prompting user to provide patient data when relevant data is missing 27FRQ-PTF-027 - System shall notify user of missing patient information that would refine search

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