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Pavel Rozhkov
Clinical Trial Matching Platform
Practical aspects & implementation details of Trial Management
The Challenge
Every year the amount of medical information is growing. Each branch of medicine synthesizes a large amount of personal and medical data. Electronic patient records, medical devices, wearable electronics: they all generate gigantic amounts of data. Modern computer science is trying to solve the issues of storing, processing and transferring information between hospitals, clinics and medical service providers.

Main challenges in software development are related to the collection, processing and analysis of medical data. The challenges are relevant due to the large number of medical data sources such as information systems and aggregators, each has its own characteristics and implementation details.

Through the analysis of medical data, researchers and doctors can test hypotheses, conduct experiments, develop new types of drugs, and develop new ways to screen for diseases. Everything is complicated by only one thing: how to collect this information.

The Sovereignty Network (TSN) turned to us to extend their system to allow researchers to create clinical trials of any complexity. TSN is a healthcare data marketplace that enables patients to compile and own their own healthcare records in one place with the ability to participate in clinical trials. Researchers should be able to recruit participants into trials depending on the enrollment criteria that can be easily fine-tuned.
Solution concept using FHIR resources
The following diagram reflects the "typical" state machine for ResearchStudy.
This paper shows how we fulfilled requirements using the ResearchStudy FHIR resource as the core of the clinical trial feature. This resource may be used to store basic information about the research, such as: name, description, reference to researcher, status, reference to plan definition. The PlanDefinition resource was used for storing the questionnaire. The Group resource was used for storing criteria of selected patients and their current number. As the main behavior template we decided to use the proposed FHIR documentation for the states of the Research Study resource. In this way we don't need to create new scenarios; just implement an already considered solution.
Personal demographic and clinical data management
One of the main functions of the system is the storage and processing of the patient's personal medical data. The patient can enter any diseases, allergies, surgeries, medicines that are provided by the SNOMED CT reference system.
Demographic and personal healthcare data management
designed by open source FHIR SDC implementation by beda.software
Clinical trial
The researcher can use several criteria for searching, which will be combined under one group. This method implements a logical AND for the search. In addition, the researcher can add a second search group; this will mean a logical OR. Any criterion other than biological sex can be specified as exclusive.

Diagnoses, procedures, and allergic reactions can be selected in two ways:
1. By drop-down list with all items;
2. By ECL expression if you are a specialist of SNOMED CT.

An important additional feature in the system is that in the form for creating criteria, you can save each group for later use. In this case, the system will prompt you to enter a name for the group, show the categories you used, the number of potential study participants, and the date when the group was saved.
New clinical trial creation by researcher
designed by open source FHIR SDC implementation by beda.software
Active phase of the clinical trial
If patients meet some of the parameters specified by the researcher, then they will be asked to participate in a clinical trial. If patients do not want to participate in the study. then they can simply ignore the offer to participate.

Forms for the trials are implemented by FHIR SDC guidance. That means we are transforming the FHIR Questionnaire resource into a form on the Web UI. All logic is stored in a questionnaire resource. This is a near zero-coding solution on the client side.

All forms for each resources are developed with our open source SDC implementation.
Active phase of the clinical trial for the participant
designed by open source FHIR SDC implementation by beda.software
The result
Each participant's response is stored in a Questionnaire Response Resource. With a single click, the researcher can get the results in CSV format. The researcher can download them directly or receive the results by email.

As a result, the researcher receives a data set in the CSV format. This format allows you to analyze the results without unnecessary manipulations, make assumptions, build hypotheses, and build machine learning models.
The result of the research in the CSV format
developed by beda.software
  • Reference
    FHIR is a standard for health care data exchange, published by HL7®.
  • Reference
    The base FHIR specification defines these resources but doesn't provide much guidance around how they should be used, nor does it set minimal expectations for interoperation.
  • Description
    SDC spec implementation as Aidbox application
  • Reference
    SNOMED International determines global standards for health terms, an essential part of improving the health of humankind.
Designed and implemented by the team of passionate health IT experts for practitioners, clinicians & researchers
  • Vadim Laletin
    Feature Lead
    Architecture/DevOps/Fullstack development
  • Elena Grednikova
    Senior Developer
    Fullstack development
  • Pavel Rozhkov
    Senior Developer
    Architecture/Fullstack development
Get free consultation
If you already have a project in mind or just want to talk about an idea you have, just drop us a line to hi@beda.software and we'll be happy to chat.