RESEARCH STUDY OF MEDICINES USING THE HUMAN BODY AFTER HIS/HER DEATH.

OBJECTIVE: The aim of this paper is to determine the legal nature and basis for the research of medicines using the human body after establishing the fact of his/her biological death. PATIENTS AND METHODS: Materials and methods: This research study is based on an analysis of the norms of international law and legislation of some states on the admissibility of the research of medicines using the human body after establishing the fact of his/her biological death. The research was carried out using the methods of dialectical and formal logic, general scientific and special legal research methods. CONCLUSION: Conclusions: The possibility of organizing and conducting research using the human body after ascertaining the fact of his/her biological death as a scientific study distinguishes such studies from related types of medicines research, proposed standardization of these studies within the preclinical research of medicines, and examination of materials funds.

CONTRACTUAL REGISTRATION OF ORGANIZATIONAL AND LEGAL RELATIONS BETWEEN SUBJECTS INVOLVED IN THE CONDUCT OF CLINICAL TRIALS OF MEDICINAL PRODUCTS.

OBJECTIVE: The aim: Determination of features of contractual registration of organizational and legal relations between the subjects involved in carrying out clinical trials of medicinal products; justification of proposals on improvement of law enforcement practice in this field. PATIENTS AND METHODS: Materials and methods: This research is based on the analysis of the norms of international law and legislation of particular states, practice of contractual registration of organizational and legal relations between the subjects of clinical trials of medicinal products. The research was carried out using the methods of dialectical and formal logic, general scientific and special legal research methods. CONCLUSION: Conclusions: Two models of contractual registration of organizational and legal relations between the subjects involved in clinical trials of medicinal products were justified, and law enforcement recommendations for the contractual registration of such relationships, ensuring that the clinical trial is in compliance with international regulations and ethics in this field, were given.

Special features of the legal status of the research subject in clinical testing of medicines.

OBJECTIVE: Introduction: The issue of the content of the legal status of the research subject in clinical testing of medicines and its distinction from the patient's legal status is of practical importance, related to the observance of ethical standards in the field of clinical trials, as well as ensuring the balance of public and private interests in this field. Although the subject of this study and the patient being treated are usually united in the intention to overcome the disease, these processes have different essence. The regulation of the legal status of the research subject should be done by legal means that are relevant to the nature of such trials and ensure the effective protection and security of the interests of these subjects. Normative regulation of the legal status of the research subject, unlike the patient, is insufficiently structured and characterized by fragmentation thus requires the doctrinal elaboration. The aim: The aim is to determine specific features of the legal status of the research subject and its difference from the patient's legal status being provided with medical care; to reason about the necessity and content of propositions to amend the current legislation of Ukraine in order to ensure the rights and legitimate interests of the research subjects. PATIENTS AND METHODS: Materials and methods: The authors used the judgements of the European Court of Human Rights (ECHR) on medical research, international and national regulatory acts, publications of scholars in the field of medical law. The research was carried out on the basis of the systematic approach using the methods of dialectical and formal logic, general scientific and specific legal methods of research. CONCLUSION: Conclusions: With the aim to ensure the proper legal protection of the rights and legal interests of the subjects of clinical trials the authors provided arguments for the need to amend the current legislation of Ukraine in order to correspond the international legal acts and ethical standards.

Etiology and efficacy of anti-microbial treatment for community-acquired pneumonia in adults requiring hospital admission in Ukraine.

BACKGROUND AND AIM: Empiric therapy of community-acquired pneumonia (CAP) remains the standard care and guidelines are mostly based on published data from the United States or Europe. In this study, we determined the bacterial etiology of CAP and evaluated the clinical outcomes under antimicrobial treatment of CAP in Ukraine. METHODS: A total of 98 adult subjects with CAP and PORT risk II-IV were recruited for the study. The sputum diagnostic samples were obtained from all patients for causative pathogen identification. Subjects were randomly assigned in a 1:1 ratio to receive delafloxacin 300 mg (n=51) or moxifloxacin 400 mg (n=47) with blinding placebo. The switch to oral treatment was after a minimum of 6 IV doses according to clinical criteria. The total duration of antibacterial treatment was 5-10 days. In vitro susceptibility of pathogens to delafloxacin and other comparator antibiotics was determined. RESULTS: The most frequently isolated pathogens in adults with CAP were S. pneumoniae - 19.5%, M. pneumoniae - 15.3%, H. influenzae - 13.2%, S. aureus - 10.5%, K. pneumoniae - 10.1%, and H. parainfluenzae - 6.4%. All isolates of S. pneumoniae, S. aureus, M. pneumoniae had sufficient susceptibility to appropriate antibiotics. 9.0% of H. influenzae strains were susceptible to azithromycin. 94.8 % of patients had a successful clinical response to delafloxacin at the end of treatment and 93.9 % - at test-of-cure. CONCLUSIONS: In Ukraine, the major bacterial agents that induced CAP in adults were S. pneumoniae, M. pneumoniae, H. influenzae, S. aureus, K. pneumoniae, H. parainfluenzae, E. cloacae, L. pneumophila. Delafloxacin is a promising effective antibiotic for monotherapy for CAP in adults and could be used in cases of antimicrobial-resistant strains.

Results of a Phase 2b Trial With GB001, a Prostaglandin D2 Receptor 2 Antagonist, in Moderate to Severe Eosinophilic Asthma.

BACKGROUND: Prostaglandin D2 receptor 2 (DP2) antagonists inhibit prostaglandin D2-induced effects, including recruitment and activation of cells driving asthma pathogenesis. However, challenges identifying target population and end points persist. RESEARCH QUESTION: What is the effect of the DP2 antagonist GB001 on asthma worsening in patients with moderate to severe eosinophilic asthma? STUDY DESIGN AND METHODS: In this phase IIb, randomized, double-blind, placebo-controlled, dose-ranging, parallel-group, multicenter study, GB001 or placebo was added to standard-of-care treatment in patients with moderate to severe asthma with a blood eosinophil count ≥ 250 cells/µL. Patients aged ≥ 18 years to < 75 years received one of four once-daily treatments (GB001 20 mg, 40 mg, or 60 mg or placebo). The primary end point was the proportion of patients who experienced asthma worsening by 24 weeks. Efficacy analyses were performed for the intention-to-treat population and safety analyses for patients who received at least one dose of study treatment. RESULTS: A total of 480 patients were treated. The ORs for asthma worsening for GB001 20 mg, 40 mg, and 60 mg vs placebo were 0.674 (95% CI, 0.398-1.142), 0.677 (95% CI, 0.399-1.149), and 0.651 (95% CI, 0.385-1.100), respectively. Analysis according to baseline blood eosinophil levels and/or fractional exhaled nitric oxide did not show greater treatment effects with higher values. Elevated liver aminotransferase levels and adverse events leading to discontinuation were more frequent for GB001 60 mg than with placebo, GB001 20 mg, and GB001 40 mg. INTERPRETATION: Although GB001 did not significantly reduce the odds of asthma worsening, reductions favoring GB001 were observed. Treatment effects were consistent regardless of high/low type 2 phenotype. The overall safety profile was acceptable, although GB001 60 mg was associated with risk of liver injury. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT03683576; URL: www. CLINICALTRIALS: gov.