AU2019273572A1 - Subject candidate extracting method, and subject candidate extracting system - Google Patents
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- G16H10/20—ICT specially adapted for the handling or processing of patient-related medical or healthcare data for electronic clinical trials or questionnaires
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Abstract
The objective of the present invention is to provide a subject candidate extracting method with which it is possible for a subject candidate matching a clinical trial plan document to be extracted in a short time period and with a high degree of accuracy.
This subject candidate extracting method includes: a step of acquiring input data in an extraction format, created on the basis of electronic medical record information, from a database in which the electronic medical record information is recorded; a step of inputting reference information defined in a clinical trial plan document; a step of extracting a subject candidate matching the clinical trial plan document from among a plurality of patients, by subjecting the input data to an extraction process using the reference information; and a step of outputting the results of the extraction process as output data in a list format.
Description
Description
Title of Invention: SUBJECT CANDIDATE EXTRACTING METHOD,
Technical Field
[0001]
The present invention relates to a subject candidate
extraction method and a subject candidate extraction
system for extracting subject candidates matching a
clinical trial protocol from multiple patients.
Background Art
[0002]
When a pharmaceutical company conducts a clinical
trial, the task of finding subject candidates matching a
clinical trial protocol of the pharmaceutical company is
conventionally done at medical institutions. However, no
system has existed in the past that can extract subject
candidates matching a clinical trial protocol in a short
time and with high accuracy.
[0003]
There has been a proposal of a system in which
patient information extracted from medical service fee
claiming systems of hospitals and the like is registered
as a database at a website on the Internet and
registration is made from a medical institution at a patient's wish before emergence of a clinical trial drug
(see Patent Literature 1, for example).
Citation List
Patent Literature
[0004]
Patent Literature 1: Japanese Patent Laid-Open No. 2003
337864
Summary of Invention
Technical Problem
[0005]
However, such a conventional system is still not
able to extract subject candidates matching a clinical
trial protocol in a short time and with high accuracy.
[0006]
In view of the challenge above, an object of the
present invention is to provide a subject candidate
extraction method that can extract subject candidates
matching a clinical trial protocol in a short time and
with high accuracy.
Solution to Problem
[0007]
A subject candidate extraction method according to
the present invention is a subject candidate extraction
method performed in a subject candidate extraction system for extracting subject candidates matching a clinical trial protocol from a plurality of patients for whom electronic health record information has been registered, the subject candidate extraction method including the steps of: acquiring input data in extraction format created based on the electronic health record information from a database in which the electronic health record information is registered; receiving an input of criteria information defined in the clinical trial protocol; extracting subject candidates matching the clinical trial protocol from the plurality of patients by performing an extraction process with the criteria information on the input data; and outputting a result of the extraction process as output data in list format.
[0008]
This allows easy extraction of subject candidates
matching the clinical trial protocol from multiple
patients. Here, subject candidates can be extracted in a
short time and with high accuracy even with an extremely
large number of patients as a population of subject
candidates.
[0009]
In the subject candidate extraction method of the
present invention, the criteria information may include
selection criteria, and in the extraction process,
subject candidates who match the selection criteria may
be selected from the plurality of patients.
[0010]
This makes it possible to appropriately select
patients who should be selected (patients satisfying the
selection criteria) as subject candidates from multiple
patients in conformance with the selection criteria
defined by the clinical trial protocol.
[0011]
In the subject candidate extraction method of the
present invention, the criteria information may include
exclusion criteria, and in the extraction process,
subject candidates who match the exclusion criteria may
be excluded from the plurality of patients.
[0012]
This makes it possible to appropriately exclude
patients who should be excluded (patients satisfying the
exclusion criteria) among multiple patients from subject
candidates in conformance with the exclusion criteria
defined by the clinical trial protocol.
[0013]
A subject candidate extraction system according to
the present invention is for extracting subject
candidates matching a clinical trial protocol from a
plurality of patients for whom electronic health record
information has been registered, the subject candidate
extraction system including: an input data acquisition
unit that acquires input data in extraction format
created based on the electronic health record information from a database in which the electronic health record information is registered; a criteria information input unit to which criteria information defined in the clinical trial protocol is input; an extraction processing unit that extracts subject candidates matching the clinical trial protocol from the plurality of patients by performing an extraction process with the criteria information on the input data; and an output unit that outputs a result of the extraction process as output data in list format.
[0014]
This system also facilitates extraction of subject
candidates matching a clinical trial protocol from
multiple patients as with the method above. Here,
subject candidates can be extracted in a short time and
with high accuracy even with an extremely large number of
patients as a population of subject candidates.
[0015]
In the subject candidate extraction system of the
present invention, the criteria information may include
selection criteria, and in the extraction process,
subject candidates who match the selection criteria may
be selected from the plurality of patients.
[0016]
This makes it possible to appropriately select
patients who should be selected (patients satisfying the
selection criteria) as subject candidates from multiple patients in conformance with the selection criteria defined by the clinical trial protocol.
[0017]
In the subject candidate extraction system of the
present invention, the criteria information may include
exclusion criteria, and in the extraction process,
subject candidates who match the exclusion criteria may
be excluded from the plurality of patients.
[0018]
This makes it possible to appropriately exclude
patients who should be excluded (patients satisfying the
exclusion criteria) among multiple patients from subject
candidates in conformance with the exclusion criteria
defined by the clinical trial protocol.
Advantageous Effect of Invention
[0019]
The present invention can extract subject candidates
matching a clinical trial protocol in a short time and
with high accuracy.
Brief Description of Drawings
[0020]
[Figure 1] Figure 1 is a block diagram of a subject
candidate extraction system in an embodiment of the
present invention.
[Figure 2] Figure 2 shows a first example of a subject
candidate extraction process in an embodiment of the
present invention.
[Figure 3] Figure 3 shows a second example of a subject
candidate extraction process in an embodiment of the
present invention.
[Figure 4] Figure 4 shows a third example of a subject
candidate extraction process in an embodiment of the
present invention.
[Figure 5] Figure 5 shows a fourth example of a subject
candidate extraction process in an embodiment of the
present invention.
[Figure 6] Figure 6 shows an example of output data in
list format in an embodiment of the present invention.
[Figure 7] Figure 7 is a flow diagram illustrating
operations of the subject candidate extraction system in
an embodiment of the present invention.
Description of Embodiments
[0021]
A subject candidate extraction method according to
an embodiment of the present invention is described below
with drawings. This embodiment illustrates a case of a
subject candidate extraction method which is used with a
subject candidate extraction system.
[0022]
A configuration of the subject candidate extraction
system according to an embodiment of the present
invention is described with reference to a drawing.
Figure 1 is a block diagram showing the subject candidate
extraction system in this embodiment. As shown in Figure
1, a subject candidate extraction system 1 is connected
with a database 3 of a medical information system 2. In
the database 3, electronic health record information for
a multitude of patients has been registered. The
database 3 also has the functions of creating and
outputting input data in extraction format (e.g., CSV
format) based on electronic health record information.
[0023]
The subject candidate extraction system 1 includes
an input data acquisition unit 4, a criteria information
input unit 5, an extraction processing unit 6, and an
output unit 7. The input data acquisition unit 4 has a
function of retrieving input data in extraction format
created based on electronic health record information
from the database 3 of the medical information system 2.
[0024]
The criteria information input unit 5 is a user
interface to which criteria information defined by a
clinical trial protocol of a pharmaceutical company is
input. The criteria information defined by the clinical
trial protocol is input by a user (such as a person in
charge at a medical institution). The criteria information includes selection criteria and exclusion criteria.
[0025]
The extraction processing unit 6 extracts subject
candidates matching the clinical trial protocol from
multiple patients by performing an extraction process
with the criteria information on input data.
Specifically, the extraction processing unit 6 selects
subject candidates who match the selection criteria and
excludes subject candidates who match the exclusion
criteria among multiple patients.
[0026]
Figures 2 to 5 show examples of the extraction
process. Figure 2 shows an example of a clinical trial
that targets diabetes patients. In the example of Figure
2, Condition 1: "taking diabetes drug DPP4", Condition 2:
"being diagnosed with diabetes", Condition 3: "HbAlc
being 8-10", and Condition 4: "being 40 to 80 years old"
are the selection criteria, and Condition 5: "not being a
cancer patient" is the exclusion criteria.
[0027]
Figure 3 shows an example of a clinical trial that
targets mild Alzheimer's dementia patients. In the
example of Figure 3, Condition 1: "having mild
Alzheimer's dementia" and Condition 2: "being 50 to 85
years old" are the selection criteria, and Condition 3:
"not being a patient using Memary" and Condition 4: "not
being a cancer patient" are the exclusion criteria.
[0028]
Figure 4 shows an example of a clinical trial that
targets multiple sclerosis patients. In the example of
Figure 4, Condition 1: "having multiple sclerosis" and
Condition 2: "being 16 to 75 years old" are the selection
criteria, and Condition 3: "not being a cancer patient"
is the exclusion criteria.
[0029]
Figure 5 shows an example of a clinical trial that
targets atrial fibrillation patients who have renal
dysfunction and are being treated with Apixaban. In the
example of Figure 5, Condition 1: "being an atrial
fibrillation patient", Condition 2: "being 75 years old
or above", Condition 3 "being a patient prescribed with
Apixaban", and Condition 4: "Cre being 1.0 or higher or
eGFR being 50 or lower" are the selection criteria, and
Condition 5: "not being a cancer patient" is the
exclusion criteria.
[0030]
The output unit 7 outputs a result of the extraction
process as output data in list format. Figure 6 shows an
example of output data for the extraction result in the
case of the clinical trial that targets diabetes patients
(the example of Figure 2). As shown in Figure 6, the
output data for the extraction result includes items such as "patient code", "type 2 diabetes patient", "alive",
"taking diabetes drug DPP4", "HbAlc of 8-10", "40 to 80
years old", and "not being a cancer patient". Of course,
other items than those described above may be included in
the output data for an extraction result.
[0031]
The "patient code" is an identification code for
identifying a patient. With the patient code, the
patient can be specified and also the personal
information of the patient can be protected. A "Type 2
diabetes patient" is data indicating whether the patient
is a type 2 diabetes patient or not at the time of
extraction. In the example of Figure 6, "0" is indicated
if the patient is a type 2 diabetes patient at the time
of extraction. "Alive" is data indicating whether the
patient is alive or not at the time of extraction. In
the example of Figure 6, "0" is indicated if the patient
has a clinic appointment at the time of extraction.
[0032]
"Taking diabetes drug DPP4" is data indicating
whether the patient is taking diabetes drug DPP4 or not
in a predetermined period (in the example of Figure 6,
from February 1 to May 1, 2018). In the example of
Figure 6, "0" is indicated if the patient is taking
diabetes drug DPP4 in that period. "HbAlc of 8-10" is
data indicating whether the HbAlc of the patient is 8-10
in a predetermined period (in the example of Figure 6, from December 1, 2017 to May 1, 2018). In the example of
Figure 6, the HbAlc value in the period is indicated.
[0033]
"40 to 80 years old" is data indicating whether the
patient is 40 to 80 years old or not at the time of
extraction. In the example of Figure 6, the patient's
age at the time of extraction is indicated. "Not being a
cancer patient" is data indicating whether the patient is
a cancer patient or not at the time of extraction. In
the example of Figure 6, "0" is indicated if the patient
is not a cancer patient at the time of extraction.
[0034]
The subject candidate extraction system 1 thus
configured is described for its operation with reference
to the flow diagram of Figure 7.
[0035]
To extract subject candidates matching a clinical
trial protocol from multiple patients for whom electronic
health record information has been registered using the
subject candidate extraction system 1 according to this
embodiment, first, input data in extraction format
created based on electronic health record information is
acquired from the database 3 of the medical information
system 2 (Si). Then, upon input of criteria information
(the selection criteria and the exclusion criteria)
defined by the clinical trial protocol (S2), an extraction process with the criteria information is performed on the input data (S3).
[0036]
As a result, subject candidates matching the
clinical trial protocol are extracted from the multiple
patients. For example, with an extraction process using
the conditions (the selection criteria and the exclusion
criteria) of Figure 2, subject candidates matching the
clinical trial protocol targeting diabetes patients (e.g.,
73 subject candidates out of all the diabetes patients)
are extracted.
[0037]
With an extraction process using the conditions (the
selection criteria and the exclusion criteria) of Figure
3, for example, subject candidates matching the clinical
trial protocol targeting mild Alzheimer's dementia
patients (e.g., 63 subject candidates out of all the
Alzheimer's disease patients) are extracted.
[0038]
With an extraction process using the conditions (the
selection criteria and the exclusion criteria) of Figure
4, for example, subject candidates matching the clinical
trial protocol targeting multiple sclerosis patients
(e.g., 23 subject candidates out of all the multiple
sclerosis patients) are extracted.
[0039]
With an extraction process using the conditions (the
selection criteria and the exclusion criteria) of Figure
, for example, subject candidates matching the clinical
trial protocol targeting atrial fibrillation patients who
have renal dysfunction and are being treated with
Apixaban (e.g., 32 subject candidates out of all the
atrial fibrillation patients) are extracted.
[0040]
Then, the result of the extraction process is output
as output data in list format (see Figure 6) (S4). In
this manner, subject candidates matching the clinical
trial protocol can be extracted from multiple patients
for whom electronic health record information has been
registered.
[0041]
The subject candidate extraction system 1 according
to this embodiment enables easy extraction of subject
candidates matching a clinical trial protocol from
multiple patients. Here, subject candidates can be
extracted in a short time and with high accuracy even
with an extremely large number of patients as a
population of subject candidates.
[0042]
This embodiment can appropriately select patients
who should be selected (patients satisfying the selection
criteria) as subject candidates from multiple patients in conformance with the selection criteria defined by the clinical trial protocol.
[0043]
This embodiment can also appropriately exclude
patients who should be excluded (patients satisfying the
exclusion criteria) among multiple patients from subject
candidates in conformance with the exclusion criteria
defined by the clinical trial protocol.
[0044]
As described above, while embodiments of the present
invention have been described by way of illustration, the
scope of the present invention is not limited thereto;
alterations or modifications may be made within the scope
set forth in the claims according to an object.
Industrial Applicability
[0045]
As described above, the subject candidate extraction
method according to the present invention has the effect
of being able to extract subject candidates matching a
clinical trial protocol in a short time and with high
accuracy, and is advantageously used with a subject
candidate extraction system.
Reference Signs List
[0046]
1 subject candidate extraction system
2 medical information system
3 database
4 input data acquisition unit
criteria information input unit
6 extraction processing unit
7 output unit
Claims (6)
- Claims[Claim 1]A subject candidate extraction method to beperformed in a subject candidate extraction system forextracting subject candidates matching a clinical trialprotocol from a plurality of patients for whom electronichealth record information has been registered, thesubject candidate extraction method comprising the stepsof:acquiring input data in extraction format createdbased on the electronic health record information from adatabase in which the electronic health recordinformation is registered;receiving an input of criteria information definedin the clinical trial protocol;extracting subject candidates matching the clinicaltrial protocol from the plurality of patients byperforming an extraction process with the criteriainformation on the input data; andoutputting a result of the extraction process asoutput data in list format.
- [Claim 2]The subject candidate extraction method according toClaim 1, wherein the criteria information includes selection criteria, and in the extraction process, subject candidates who match the selection criteria are selected from the plurality of patients.
- [Claim 3]The subject candidate extraction method according toClaim 1 or Claim 2, whereinthe criteria information includes exclusion criteria,andin the extraction process, subject candidates whomatch the exclusion criteria are excluded from theplurality of patients.
- [Claim 4]A subject candidate extraction system for extractingsubject candidates matching a clinical trial protocolfrom a plurality of patients for whom electronic healthrecord information has been registered, the subjectcandidate extraction system comprising:an input data acquisition unit that acquires inputdata in extraction format created based on the electronichealth record information from a database in which theelectronic health record information is registered; a criteria information input unit to which criteria information defined in the clinical trial protocol is input; an extraction processing unit that extracts subject candidates matching the clinical trial protocol from the plurality of patients by performing an extraction process with the criteria information on the input data; and an output unit that outputs a result of the extraction process as output data in list format.
- [Claim 5]The subject candidate extraction system according toClaim 4, whereinthe criteria information includes selection criteria,andin the extraction process, subject candidates whomatch the selection criteria are selected from theplurality of patients.
- [Claim 6]The subject candidate extraction system according toClaim 4 or Claim 5, whereinthe criteria information includes exclusion criteria,andin the extraction process, subject candidates whomatch the exclusion criteria are excluded from theplurality of patients.
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JP2018098405A JP6974256B2 (en) | 2018-05-23 | 2018-05-23 | Subject candidate extraction method and subject candidate extraction system |
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PCT/JP2019/020390 WO2019225678A1 (en) | 2018-05-23 | 2019-05-23 | Subject candidate extracting method, and subject candidate extracting system |
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JP6974256B2 (en) * | 2018-05-23 | 2021-12-01 | シミックヘルスケア・インスティテュート株式会社 | Subject candidate extraction method and subject candidate extraction system |
KR102251778B1 (en) * | 2020-07-07 | 2021-05-14 | 울산대학교 산학협력단 | Apparatus, method, computer-readable storage medium and computer program for sorting clinical trial subject |
JP6887194B1 (en) * | 2020-09-14 | 2021-06-16 | 株式会社Arblet | Information processing systems, servers, information processing methods and programs |
JP6869584B1 (en) * | 2020-09-14 | 2021-05-12 | 株式会社Arblet | Information processing systems, servers, information processing methods and programs |
KR102397234B1 (en) * | 2020-09-17 | 2022-05-12 | 가천대학교 산학협력산 | Method and system for assessing medication adherence |
KR102536431B1 (en) * | 2022-10-12 | 2023-05-26 | 주식회사 사이클룩스 | Method And Systems for Managing Clinical Trial Based on Gait Analysis |
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JP2006323864A (en) * | 2000-04-28 | 2006-11-30 | Mebix Kk | Clinical test performance management system |
JP2003337864A (en) | 2002-05-17 | 2003-11-28 | Ogawa Masanori | Business model for registration and collation of candidate subject of clinical trial |
JP3840481B2 (en) * | 2003-05-15 | 2006-11-01 | 嘉久 倉智 | Clinical trial management system and method using case database |
JP2004348271A (en) * | 2003-05-20 | 2004-12-09 | Sanyo Electric Co Ltd | Clinical trial data outputting device, clinical trial data outputting method, and clinical trial data outputting program |
JP2006107055A (en) * | 2004-10-04 | 2006-04-20 | Gunma Univ | Clinical test protocol execution system, clinical test protocol execution method and clinical test protocol execution program |
JP2006215820A (en) * | 2005-02-03 | 2006-08-17 | Gunma Univ | Clinical trial management system and clinical trial management method |
EP2044431B1 (en) * | 2006-07-17 | 2019-04-24 | H. Lee Moffitt Cancer Center & Research Institute, Inc. | Computer systems and methods for selecting subjects for clinical trials |
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JP6135241B2 (en) * | 2013-03-28 | 2017-05-31 | 富士通株式会社 | Program, clinical trial candidate extraction method, and clinical trial candidate extraction apparatus |
JP6338957B2 (en) * | 2014-07-22 | 2018-06-06 | 株式会社メディカルフロント | Clinical trial compatible patient selection device, system and method |
CN106980767A (en) * | 2017-03-31 | 2017-07-25 | 上海森亿医疗科技有限公司 | A kind of data search method and system based on structured medical database |
CN107480456A (en) * | 2017-08-22 | 2017-12-15 | 浙江大学医学院附属第医院 | clinical trial management method and system |
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KR20210015767A (en) | 2021-02-10 |
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