WO2018190479A1 - Method for matching clinical trial information between clinical trial volunteers and medical institution conducting clinical trial - Google Patents

Abstract

Disclosed in the present invention is a method for matching clinical trial information between clinical trial volunteers and a medical institution conducting a clinical trial, comprising the steps of: a clinical trial information integration server collecting and categorizing clinical trial volunteer recruitment notices; generating a basic digital medical examination chart and providing same to a terminal of the clinical trial volunteers; comparing and determining eligible medical examination charts from among medical examination charts of the clinical trial volunteers and notifying eligibility through the terminal of the clinical trial volunteers. As a result, limitation to access to clinical trial information, which is limited by medical institutions conducting a clinical trial or by region, can be resolved, work efficiency can be increased by significantly reducing excessive inquiry calls made by clinical trial volunteers regarding clinical trial eligibility, and appropriate medical ethics can be observed by transparently managing clinical trial volunteer information.

Description

Clinical trial information matching method between clinical trial volunteer and clinical research institute

The present invention relates to a clinical trial information matching technology, and more particularly, to a method for matching clinical trial information between a clinical trial volunteer and a clinical research institute or a research institute.

As is well known, it takes considerable time and effort to develop a medicament for the treatment or prophylaxis of a particular disease, and the development of a therapeutic agent necessitates a clinical trial to confirm the efficacy and side effects of the candidate substance studied.

On the other hand, in order to obtain meaningful clinical trial data, the process of recruiting the candidates suitable for the clinical trial is preceded, and offline recruitment of volunteers for unspecified trials or unilateral recruitment of volunteers using the Internet is being made. .

However, it is very difficult to recruit suitable candidates within the period of validity because of limited access to information due to the regional limitations of the clinical institution in charge of the study. Waste is present

In addition, the recruitment announcement of clinical trial volunteers through the Internet can overcome local limitations, but there is a problem that filtering of duplicate volunteers is impossible due to the confidentiality of clinical trial volunteer information between the clinical trial supervisors.

The present invention has been made to solve the above-mentioned problems of the prior art, collects the clinical trial volunteer recruitment provided from the clinical institution in charge of the investigation online, and the basic digital questionnaire information and clinical trial volunteer questionnaire information required for the clinical trial The task is to provide a method for matching clinical trial information between clinical trial volunteers and clinical research institutes that can be digitally matched and screened and filtered eligible or ineligible subjects.

The technical problem to be solved by the present invention does not need to be limited to the technical problem mentioned above, and other technical problems that are not mentioned are clearly to those skilled in the art from the following description. It can be understood.

In order to achieve the above object, an embodiment of the present invention is to receive and install the clinical trial support app from the clinical trial information integrated server to the clinical trial volunteer terminal and the clinical trial information integrated server, from the clinical trial volunteer terminal Receiving and storing basic personal and physical information of a clinical trial volunteer; searching and collecting the clinical trial volunteer recruitment notice announced by the clinical research institute; and classifying the collected clinical trial volunteer recruitment notice. And generating and storing the basic digital questionnaire corresponding to the clinical trial volunteer recruitment information, and providing the clinical trial volunteer recruitment announcement and the basic digital questionnaire to the clinical trial volunteer terminal. The basic digital provided to the test volunteer terminal Generating a clinical trial volunteer questionnaire according to the information inputted from the questionnaire and transmitted from the clinical trial volunteer terminal, and comparing the basic digital questionnaire information and the clinical trial volunteer questionnaire information to determine eligibility or ineligibility of the clinical trial subject Between the clinical trial volunteer and the clinical trial management institution, comprising: informing the clinical volunteer volunteer terminal whether the clinical trial candidate is eligible or ineligible; and providing the clinical trial volunteer questionnaire information to the primary clinical research institute. Provide clinical information matching method.

Preferably, the collected clinical trial volunteer recruitment notification may be classified by disease name, medical department, body part, and region to generate the clinical trial volunteer recruitment information.

Preferably, the method may further include generating an additional digital questionnaire requested by the clinical trial management institution and providing it to the qualified volunteer terminal.

Advantageously, said additional digital questionnaire may comprise a short answer questionnaire.

Preferably, the method may further include transmitting the interview request information requested from the clinical trial management institution to the qualified volunteer terminal.

Preferably, the method may further include translating and providing a domestic clinical trial information provided in a foreign language to a foreign clinical trial information site in a Korean language.

Preferably, the clinical trial volunteer questionnaire may be analyzed to further filter the clinical trial overlap support within a specific period of time to further determine the eligibility or ineligibility of the clinical trial subject.

Preferably, the method may further include the step of receiving registration and management of clinical trial subject medical institution information and clinical trial volunteer recruitment information from the clinical trial subject medical institution.

Preferably, for a specific clinical trial not announced by the clinical trial supervisory medical institution, the trial volunteer information for the specific clinical trial is first received and stored from the clinical trial volunteer terminal, and subsequently, the clinical trial administration When the clinical trial volunteer recruitment notice for the specific clinical trial is registered from a medical institution, the clinical trial volunteer recruitment notification is notified to the clinical trial volunteer terminal, and the clinical trial volunteer information received in advance transmits the specific clinical trial registration notification. It may include a period of validity information, and further comprising the step of notifying the clinical volunteer volunteer terminal whether the extension of the validity of the specific clinical trial registration notification at the end of the validity period and to stop or extend the registration notification for this; have.

According to the present invention, by collecting the clinical trial volunteer recruitment announcement announced by the pharmaceutical company, each medical organization, medical institution or clinical trial conducting institution to digitally match the basic digital questionnaire information required for the clinical trial and the corresponding clinical trial volunteer questionnaire information Afterwards, the most appropriate clinical trial volunteers for the clinical trial can be easily selected as qualified and ineligible candidates, and among the qualified persons, the overlapping clinical trial volunteers are filtered within a specific period of time, and the personnel involved in the recruitment of clinical trial volunteers and the clinical trial process. And by reducing the cost significantly, there is an effect that can contribute to the health promotion of the clinical trial volunteers.

In addition, it is possible to remove the restriction of clinical trial volunteers 'access to clinical trial information limited by the clinical institution or region, and to improve work efficiency by significantly reducing the number of clinical trial volunteers' inquiries about eligibility for excessive clinical trials. In addition, transparent and sound management of clinical trial volunteer information has the effect of achieving good medical ethics.

Here, since the effects of the present invention described above are naturally manifested by the configuration of the described contents irrespective of whether or not the inventor recognizes them, the above-described effects are only some effects according to the described contents, and all the effects grasped or actual by the inventors. It should not be accepted that it is listed.

1A is a schematic flowchart of a method for matching clinical trial information between a clinical trial volunteer and a clinical trial supervising medical institution according to a preferred embodiment of the present invention.

FIG. 1B is a schematic flowchart of an unregistered clinical trial processing step of the clinical trial information matching method of FIG. 1A.

Hereinafter, with reference to the accompanying drawings will be described in detail an embodiment of the present invention having the features described above.

1A is a schematic flowchart of a method for matching clinical trial information between a clinical trial volunteer and a clinical trial supervising medical institution according to a preferred embodiment of the present invention.

Referring to Figure 1a, the clinical trial information matching method between the clinical trial volunteer and the clinical trial host medical institution according to the preferred embodiment of the present invention, clinical trial support app transmission step (S110), volunteer information storage step (S210), the collection step (S220), classification step (S230), generation step (S240), the basic digital questionnaire providing step (S250), clinical trial volunteer questionnaire generation step (S260), determination step (S270) and eligible questionnaire providing step 280 do.

First, in the clinical trial support app transmission step (S110), the clinical trial volunteer terminal 100 receives and installs the clinical trial support app from the clinical trial information integration server 200 (S110).

Thereafter, in the volunteer information storage step (S210), the basic personal information and body information of the clinical trial volunteer are received and stored from the clinical trial volunteer terminal 100. For example, basic personal information includes gender, age (date of birth), contact information (email or mobile phone), and local information (volunteer address). Physical information includes past and current medical history, weight, height, weight and height, BMI index, Blood type information, whether they have participated in the trial, whether they have participated in the trial within a specific time period (eg, within the last three months), or whether they smoked and drank, and how much and how much they smoked.

Then, in the collection step (S220), the clinical trial subject medical institution 300, that is, the search for the clinical trial volunteers announced from the pharmaceutical company, each medical group, medical institution or clinical trial conduct online search and collect the DB (not shown) Store in

Subsequently, in the classification step (S230), the collected and stored clinical trial volunteers are classified, and the collected clinical trial volunteers are classified into disease names, medical departments, body parts, and regions (by clinical trial subject medical institution location). Recruitment announcement information can be generated.

For example, in the classification step S230, cancer (detailed lung cancer, non-small cell lung cancer, adenocarcinoma, gastric cancer, breast cancer, rectal cancer, lymphoma or multiple myeloma), diabetes, arthritis, hepatitis, leukemia, high blood pressure, Alzheimer's disease, ulcer or asthma By disease name, family medicine, internal medicine (in detail, infectious medicine, endocrine medicine, endocrine metabolism or rheumatology), surgery, neurology, anesthetic pain medicine, urology, radiation oncology, gynecology, radiology, ophthalmology, otolaryngology, rehabilitation medicine , Head / face (eyes, ears, nose, teeth, oral cavity, tongue, gums or jaw), neck / chest, abdomen, pelvis or arm /, by treatments such as mental health medicine, dentistry, dermatology, pediatric adolescents or clinical pharmacology. By body parts, such as legs, it can be classified to generate recruitment information for clinical trial volunteers.

Subsequently, in the generation step (S240), a basic digital questionnaire table for questioning the necessary items comprehensively corresponding to the clinical trial volunteer recruitment announcement information generated above is generated and stored.

Here, the basic digital questionnaire is a pre-test questionnaire, and includes gender, age (date of birth), local information (volunteer address), weight, height, BMI index according to weight and height, blood type information, participation in clinical trials, and recent specific period ( For example, within the last three months), multiple-choice questions about whether or not you have participated in clinical trials, or whether smoking and drinking, and how much and how much you smoke.

Subsequently, in the basic digital questionnaire providing step (S250), the detailed clinical trial volunteer recruitment announcement and basic digital questionnaire provided by the clinical trial supervising medical institution 300 are classified by disease name, medical department, body part, and region. 100) can be provided in the form of clinical trial support app, but can also be provided in the form of web services.

Then, in the clinical trial volunteer questionnaire generation step (S260), the clinical trial volunteer questionnaire is generated according to the questionnaire content information inputted according to the basic digital questionnaire provided to the clinical trial volunteer terminal 100 and transmitted from the clinical trial volunteer terminal 100. do.

Subsequently, in the determination step (S270), the basic digital questionnaire information and the clinical trial volunteer questionnaire information are compared to determine whether the clinical trial volunteer is eligible or ineligible for the clinical trial volunteer suitable for the clinical trial request. Here, the basic digital questionnaire information includes information on qualified or ineligible conditions for basic essential items that are comprehensively applicable to the clinical trial.

On the other hand, in the determination step (S270), by analyzing the clinical trial volunteer questionnaire to filter (screen) whether or not overlapping clinical trial support within a specific period of time, it is possible to further determine the eligibility or ineligibility of the clinical trial subjects.

Thereafter, in the notification step (S270), the clinical trial volunteer terminal 100 to promptly send by SNS, text or e-mail whether the clinical trial subjects qualified or ineligible.

Then, in the qualifying questionnaire providing step (S280), the qualified clinical trial volunteer questionnaire information is sent to SNS, text or e-mail to the clinical investigation subject medical institution 300 is provided quickly.

Meanwhile, the interview request information transmitting step S291 may be further performed to transmit the interview request information requested from the clinical trial administration medical institution 300 to the qualified volunteer terminal 100.

Here, in the interview request information transmission step (S291), the call center for the subsequent services to the clinical trial volunteers and the clinical trial host medical institution may be on behalf of the processing of the work.

In addition, an additional digital questionnaire providing step (S292) may be further provided to generate an additional digital questionnaire requested by the clinical trial administration medical institution 300 and provide it to the eligible volunteer terminal 100.

Here, in the additional digital questionnaire providing step (S292), it is possible to provide an additional digital questionnaire including an additional or detailed subjective questionnaire according to the request of the clinical trial supervisor.

In other words, the basic digital questionnaire can quickly filter clinical trial volunteers to basic or standard questionnaire information that is comprehensively applied to clinical trials with low or low frequency of registration, thus preventing duplication of clinical trial volunteers within a specific period of time. Participation can be prevented, and the additional digital questionnaire transmits the interview request information to the qualified volunteer terminal 100 so that the candidates who are more optimized for the clinical trial can be selected.

In addition, it may further include a translation step (S293) for translating the domestic clinical trial information provided in a foreign language to the overseas clinical trial information site in Korean.

For example, in the translation step S293, as an artificial intelligence specialized for translation, the clinical trial information should be announced to the Korea Food and Drug Administration or related overseas site according to the clinical trial disclosure principle. In order to improve the accessibility and understanding of the translation into Korean may be provided to the clinical trial volunteer terminal (100).

In addition, the clinical trial subject medical institution 300 may further include a registration and management step (S294) of directly receiving and registering the clinical trial subject medical institution information and clinical trial volunteer recruitment information without separate collection steps.

FIG. 1B is a schematic flowchart of an unregistered clinical trial processing step of the clinical trial information matching method of FIG. 1A.

Referring to FIG. 1B, in a non-registered clinical trial processing step (S295), for a specific clinical trial not announced by the clinical trial supervisory medical institution 300, a clinical trial volunteer for a specific clinical trial from the clinical trial volunteer terminal 100. Receive prior information and store the information, and if the clinical trial volunteer recruitment announcement for a specific clinical trial is registered in the future clinical trial supervision medical institution 300, and informs the clinical trial volunteer recruitment registration to the clinical trial volunteer terminal 100 (S295-1), the clinical trial volunteer information received in advance includes the expiration date information of the specific clinical trial registration notification, and the clinical trial volunteer terminal 100 whether to extend the validity period of the specific clinical trial registration notification at the end of the validity period (S295-1). To notify and to stop or extend the registration notification (S295-2).

For example, unlike a general disease, the clinical trial information integration server 200 receives the clinical trial volunteer information from the clinical trial volunteer terminal 100 in advance for a rare disease or a desired clinical trial having a very low frequency of clinical trial volunteer notification. After storing in the DB, the clinical trial volunteer recruitment announcement for the rare disease or desired clinical trial described above is registered from the clinical institution administering the clinical trial 300, the clinical trial information integrated server 200 is the clinical trial volunteer terminal 100 As a result, SNS, a text message, or an e-mail notification of the registration notification of clinical trial volunteer recruitment and the notification of clinical trial volunteer recruitment (S295-1).

In addition, the clinical trial volunteer information received in advance includes information on the validity period of a specific clinical trial registration notification, and the clinical trial information integration server 200 determines whether to extend the validity period of the specific clinical trial registration notification at the end of the validity period. It may be transmitted to the volunteer terminal 100 and the corresponding registration notification may be stopped or extended (S295-2).

Therefore, by configuring the clinical trial information matching method as described above, the restriction on access to the clinical trial information limited by the clinical trial supervising medical institution or region is eliminated, and a significant number of clinical trial volunteers' inquiries about eligibility for clinical trials are significantly increased. Reduce the efficiency of related tasks and implement correct medical ethics with transparent clinical trial volunteer information management.

On the other hand, clinical trials and (biological) bioequivalence tests are strictly distinguished concepts, but only the matching techniques related to the clinical trials have been described in detail above, but the matching method according to the present invention may be equally applicable to bioequivalence studies, and The bioequivalence test may further include the steps of collecting, classifying, generating, storing, providing, selecting, judging and informing the bioequivalence test.

In addition, it may be understood that the clinical institution managing the study encompasses the relevant server of the clinical research institution or the terminal of the clinical research institution.

Configurations shown in the embodiments and drawings described herein are only one of the most preferred embodiments of the present invention, and do not represent all of the technical spirit of the present invention, various equivalents that may be substituted for them at the time of the present application It should be understood that there may be water and variations.

The present invention collects the recruitment announcement of clinical trial volunteers announced by pharmaceutical companies, medical organizations, medical institutions or clinical trial institutes, and digitalizes the basic digital questionnaire information required for the clinical trial and the corresponding clinical trial volunteer questionnaire information. To make it easier to select the most appropriate clinical trial volunteers for the clinical trial as eligible and ineligible, and to filter the duplicated clinical trial volunteers within a specific period of time, the human resources and costs involved in recruiting the clinical trial volunteers and proceeding of the clinical trial Significant savings can be made to contribute to the health promotion of clinical trial volunteers, eliminating the restriction of clinical trial volunteers' access to clinical trial information limited by the clinical institution or region. Clinical trial eligibility It can significantly reduce improve work efficiency, and transparency and it is industrially very useful as it can implement the preferred medical ethics in the right clinical trial volunteers information management.

Claims (9)

A clinical trial volunteer terminal receiving and installing a clinical trial support app from an integrated clinical trial information server; And The clinical trial information integration server, receiving and storing basic personal information and physical information of the clinical trial volunteer from the clinical trial volunteer terminal, and searching and collecting the clinical trial volunteer recruitment notice announced from the clinical research institute. And classifying the collected clinical trial volunteer recruitment announcement, generating and storing a basic digital questionnaire corresponding to the clinical trial volunteer announcement information, and storing the clinical trial volunteer recruitment announcement and the basic digital questionnaire. Providing to the clinical trial volunteer terminal, generating a clinical trial volunteer questionnaire according to the information transmitted from the clinical trial volunteer terminal inputted according to the basic digital questionnaire provided to the clinical trial volunteer terminal, and Digital Questionnaire Information Comparing the clinical trial volunteer questionnaire information to determine whether the clinical trial candidate is eligible or ineligible; notifying the clinical trial volunteer terminal whether the clinical trial candidate is eligible or ineligible; and the qualified clinical trial volunteer questionnaire information. Providing to the host medical institution; Clinical trial information matching method between the clinical trial volunteer and the clinical trial host medical institution, characterized in that consisting of. The method of claim 1, The method for matching clinical trial information between the clinical trial volunteer and the clinical institution in charge of the clinical trial volunteer is characterized in that the clinical trial volunteer recruitment notification information is generated by classifying the collected clinical trial volunteer recruitment notification by disease name, medical department, body part and region. The method of claim 1, Method for matching clinical trial information between the clinical trial volunteer and the clinical trial host medical institution, characterized in that it further comprises the step of transmitting the interview request information requested from the clinical trial host medical institution to the qualified volunteer terminal. The method of claim 1, Generating an additional digital questionnaire requested by the clinical trial host medical institution and providing to the eligible volunteer terminal terminal, clinical trial information matching method between the clinical trial volunteer and the clinical trial host medical institution. The method of claim 4, wherein The additional digital questionnaire includes a subjective questionnaire, clinical trial information matching method between the clinical trial volunteer and the clinical trial host medical institution. The method of claim 1, The method for matching clinical trial information between a clinical trial volunteer and a clinical institution in charge of a clinical trial further comprising the step of translating the domestic clinical trial information provided in a foreign language into a foreign clinical trial information site. The method of claim 1, The method for matching clinical trial information between the clinical trial volunteer and the clinical institution in charge of the clinical trial characterized in that the clinical trial volunteer questionnaire is analyzed to further filter the clinical trial overlap support within a specific period to further determine whether the trial candidate is eligible or ineligible. The method of claim 1, The clinical trial information matching method between the clinical trial volunteer and the clinical trial host medical institution further comprising the step of receiving and registering the clinical trial subject medical institution information and clinical trial volunteer recruitment information from the clinical trial host medical institution. The method of claim 1, Regarding a specific clinical trial not announced by the clinical trial supervisory medical institution, the clinical trial volunteer information for the specific clinical trial is preliminarily received and stored from the clinical trial volunteer terminal, and later, the specific clinical trial is managed by the clinical trial supervising medical institution. When the clinical trial volunteer recruitment notice for the clinical trial is registered, the clinical trial volunteer recruitment notification is notified to the clinical trial volunteer terminal, The clinical trial volunteer information received in advance includes information on the validity period of the specific clinical trial registration notification, and at the end of the validity period, notify the clinical research volunteer terminal whether the specific clinical trial registration notification is extended. Stopping or extending the registration notification for the clinical trial information matching method between the clinical trial volunteer and the clinical trial host.

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