матолінець

New Clinical Research Center Established

Introduction to the New Center

• The new clinical research center opened on November 28 at the university hospital, providing Ukrainian patients access to advanced treatment methods and medications before they are widely available. This initiative aims to enhance opportunities for scientific development and medical practice.

Purpose of the Clinical Research Center

• Professor Natalia Matolinec from Lviv National Medical University explains that the center is part of a pilot project initiated by the Cabinet of Ministers of Ukraine aimed at creating a university hospital. This transition allows for better integration of education, science, and clinical practice in medicine.

Structure of the University Hospital

• The Lviv National Medical University now operates a unified university clinic with over 100 beds, combining two campuses: one previously belonging to the railway system and another that was an oblast clinical hospital. This structure supports comprehensive educational processes alongside practical medical applications.

Goals of the Research Center

• The center's primary goal is to establish a closed-loop cycle for developing new drugs, innovative technologies, and medical devices that require clinical trials before becoming available for general use. It serves as a critical link in providing potentially life-saving treatments to patients ahead of broader market availability.

Clinical Trials Process Explained

Patient Selection for Trials

• Patients will be selected based on specific criteria aligned with various medical programs; this ensures that only suitable candidates participate in trials conducted at the university clinic in collaboration with pharmaceutical companies seeking to test new products.

Collaboration with Pharmaceutical Companies

• The center acts as a hub where international pharmaceutical companies can conduct clinical trials under strict regulatory compliance, ensuring ethical standards are met throughout the process. Contracts are established between these companies and the research center for conducting trials on-site while adhering to Ukrainian legislation.

Current Status of Clinical Trials

• As of now, approximately 60 active or partially suspended clinical trials exist due to ongoing military actions in Lviv, focusing primarily on oncology but also covering endocrinology, rheumatology, gastroenterology, and pulmonology among other specialties within medicine. The aim is to expand participation in more global-level studies moving forward.

Research Focus Areas

Types of Diseases Under Investigation

• A significant number of studies focus on cancer treatment innovations as well as antimicrobial and antiviral drug efficacy due to their relevance as global health issues today—particularly concerning antibiotic resistance which complicates treatment options for many infections. Additionally, research includes systemic connective tissue diseases and orphan diseases affecting smaller patient populations but requiring urgent attention due to their severity.

Addressing Patient Disability and Research Participation

Challenges in Treating Complex Diseases

• The discussion highlights the ongoing global efforts to find solutions for treating severe conditions such as systemic lupus erythematosus and Wilson's disease, which are complex hematological disorders.

• There is a strong emphasis on the need for collaboration within the international medical community to tackle these challenging health issues.

Becoming a Participant in Clinical Research

• The process of becoming involved in clinical research is described as intricate, requiring regulatory approvals from multiple companies involved in the study. This includes the sponsor company and intermediary organizations.

• A significant aspect of this process involves obtaining Good Laboratory Practice certification to ensure compliance with testing standards, which is crucial for maintaining patient safety and data integrity.

Structure and Personnel of the Research Center

• The center aims to integrate various scientific disciplines, employing qualified professionals including doctors, interns, researchers with advanced degrees (PhDs), and administrative staff to facilitate clinical trials effectively.

• It consists of specialized units such as molecular design labs, toxicology labs, microbiological research centers, and epidemiology institutes that work together under one organizational structure.

Involvement of Students and Interns

• Students and interns will play an active role in both theoretical learning at academic departments (pharmacy, pharmacology) and practical applications at clinical sites where patient care occurs. Their involvement will be closely supervised by faculty members to ensure quality control during trials.

• The university hospital provides a comprehensive platform for students to gain hands-on experience while contributing meaningfully to clinical research initiatives under expert guidance.

Impact of War on Clinical Research Opportunities

• The conversation touches upon how ongoing conflict has affected the ability to conduct clinical studies effectively, indicating that this remains a sensitive yet critical topic for discussion among healthcare professionals today.

Clinical Trials in Ukraine During War

Impact of War on Clinical Research

• The onset of war has led to a significant decrease in clinical trials, with new studies halting due to safety concerns.

• Despite the challenges, there has been an annual increase of 15-20% in companies returning to Ukraine and resuming operations over the past four years.

Ministerial Insights on Clinical Trials

• Health Minister Viktor Lyashko emphasized the importance of trust and capability in conducting clinical trials during wartime at a forum held on November 28, 2022.

• He acknowledged that security concerns remain critical but highlighted ongoing efforts to demonstrate reliability and commitment to continuing research activities.

Unique Opportunities for Medical Research

• Ukraine's unique experiences during the war provide valuable opportunities for advancing medical science, particularly regarding treatment mechanisms and innovative methodologies.

• The country aims to leverage its situation to potentially discover new drugs or treatment methods based on extensive patient experiences, including those injured by the conflict.

Focus Areas in Military Medicine

• There is a strong focus on researching PTSD, rehabilitation, and various injuries related to military conflicts as part of ongoing studies.

• The forum attracted numerous international partners interested in mental health research related to war trauma and rehabilitation strategies.

Strategic Plans for Rehabilitation Research

• The Lviv National Medical University prioritizes mental health, military trauma, and rehabilitation within its strategic plan for the next two years while also addressing global health challenges like oncology and antimicrobial resistance.

• There is significant interest from communities and organizations wanting to study treatment methods specifically tailored for patients affected by war injuries.

Patient Participation in Research Studies

• Individuals can participate in open studies or propose their cases directly without needing prior recommendations from doctors; this process is being developed further.

• Information about participation will be available through Lviv National Medical University's website under the Clinical Trials Coordination Center section starting next week.

Future Success Metrics for Research Center

• A successful first year would involve practical integration between university hospital units into cohesive clinical structures rather than just theoretical collaboration.

• Goals include increasing existing trial numbers while launching new initiatives focused on mental health issues stemming from military trauma among other areas of concern such as outpatient care requests directly from patients seeking help.

International Collaboration in Experimental Medicine

Current State of International Partnerships

• The discussion highlights the establishment of a comprehensive query base to explore experimental treatment methodologies, particularly in oncology, which is currently experiencing unprecedented global interest.

• Despite the ongoing war in Ukraine, numerous international companies remain committed to collaboration, with over 20 agreements signed between Lviv National Medical University and various global partners since early 2023.

Key Collaborations and Initiatives

• Active partnerships include significant contributions from French companies that facilitated the launch of an orthotic center, now operational and conducting research in prosthetics.

• A virtual children's hospital platform named "Nadiya" has been developed with international partners focusing on child mental health research related to wartime experiences.

Research Focus Areas

• Collaborative efforts extend to surgical simulation centers for war trauma and preclinical research involving new drug trials with partners from Poland, the Baltic states, Germany, the USA, and Canada.

Inclusion Criteria for Patients

• There are no legal age restrictions for patient participation in experimental programs; thus, researchers can work with various age groups as permitted by Ukrainian law. Plans are underway to study child mental health starting from two years old.

Vision for Regional Impact

• The conversation shifts towards the broader implications for Lviv and its region. The aim is to achieve leadership status in medical education and healthcare by integrating tradition with innovation.

• Emphasis is placed on developing empathy and compassion within medical practice while advancing clinical trials and new technologies that will benefit both patients and students alike.

Aspirations for Future Leadership

• The goal articulated is to position Lviv as a leading hub for medical education and innovative research within a global scientific framework.

• A heartfelt wish is expressed for successful outcomes not only for patients but also for all involved stakeholders as they navigate through treatments at these advanced facilities.