W3C Life Sciences: Clinical Observations Interoperability: EMR + Clinical Trials
Use-case for EMR + Clinical Trials Interoperability
Background:
The key issue is to investigate whether some of the data collected in a clinical encounter can be re-used in the context of a clinical study.
Constructs of particular interest to the W3C working group from July 2007 include:
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Vital Signs
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Chemistry Panel (Labs)
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Problems and Diagnoses
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Imaging Biomarker
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C-Reactive Protein
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Scenario:
Examine patient data from EMR, and compare with protocol eligibility information to screen for potential research subjects or to estimate possible # of potential research subjects.
Approach: Have a protocol in mind first, scan EMR records with that eligibility criteria in mind.
Research Protocol
Eligibility Criteria:
Inclusion
Constructs & Logic/values…
Exclusion Constructs & Logic/values…
EMR Data
Clinical Data Model

query
Examples of Trials and Eligibility Criteria from ClinicalTrials.gov
Trial #1:
Prophylactic Irradiation to the Contralateral Breast for BRCA Mutation Carriers Undergoing Treatment for Breast Cancer
http://www.clinicaltrials.gov/ct/show/NCT00496288?order=2
Eligibility
Ages Eligible for Study: 30 Years - 90 Years, Genders Eligible for Study: Female
Criteria
Inclusion Criteria:
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Female patient diagnosed with stage I-III breast cancer (AJCC 6), undergoing breast irradiation as part of her adjuvant therapy.
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The patient must be a carrier of a deleterious mutation in BRCA 1/2.
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Age above 30 years.
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The patient may receive any regimen of adjuvant chemotherapy, according to the treating physician. All cycles of chemotherapy must be completed at least 3 weeks prior to the start of radiation therapy.
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The patient may be treated with hormonal therapy before, during or after study entry, according to the guidelines of her treating center.
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The patient must have negative gadolinium based MRI of the contralateral breast, no more than 6 months prior to study entry.
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The patient refused prophylactic contralateral mastectomy.
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The patient is aware that subsequent breast cancer in the irradiated breast will probably mandate mastectomy.
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The patient consent for contralateral prophylactic irradiation. -
Exclusion Criteria:
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Metastatic breast cancer.
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Previous irradiation of the breast or chest wall.
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Pregnancy.
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No concurrent chemotherapy is allowed
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Patients with active connective tissue diseases are excluded due to the potential risk of significant radiotherapy toxicity.
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Patients who are unable to lie on their back and raise their arms above their heads in the treatment planning position for radiotherapy are excluded -
Trial #2:
Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole
http://www.clinicaltrials.gov/ct/show/NCT00316836?order=4
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Criteria
DISEASE CHARACTERISTICS:
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Histologically confirmed invasive breast cancer
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Completely resected disease
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One intact, noncancerous breast with no prior breast surgery in that breast except breast biopsy
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Estrogen receptor- and/or progesterone receptor-positive tumor
PATIENT CHARACTERISTICS:
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Female
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Postmenopausal
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Agrees to retrieve and digitize mammograms taken prior to registration (within 12 months prior to study entry) and at approximately 1 and 2 years post-registration to this study
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Agrees to have an additional blood banking specimen drawn at the same time as pre-treatment specimens are drawn for parent protocol CAN-NCIC-MA27
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Agrees to have blood sample taken at 12 months post-registration on this study
PRIOR CONCURRENT THERAPY:
Trial #3:
Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
http://www.clinicaltrials.gov/ct/show/NCT00445445?order=13
Eligibility
Ages Eligible for Study: 50 Years and above, Genders Eligible for Study: Female
Accepts Healthy Volunteers
Criteria
DISEASE CHARACTERISTICS:
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Meets 1 of the following criteria:
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Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system AND meets the following criteria:
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Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
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Healthy participant who is receiving routine medical care (e.g., screening mammograms) at the University Hospitals Health System
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Underwent ≥ 4 prior screening mammograms at the Breast Center since 1994
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No known carriers of BRCA1 or BRCA2 genes
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Hormone receptor status:
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Known estrogen and/or progesterone receptor status
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Future Steps:
Approve overall scenario.
Determine which constructs of most interest.
Identify protocol(s) with those information types.
Landen comment on relationship of CDISC standards to this use case…. (CDISC Protocol Representation Standard..?) |