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1
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Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE

100%
Czarny P.
Zeszyty Prawnicze BAS
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2012
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issue 4(36)
149-158
EN
The main point of the legal opinion is the question of conformity with Poland’s Constitution of the proposal for regulation of the European Parliament and of the Council [COM (2012) 369 final]. In provides an in-depth analysis of matter presented (only in general terms) in the opinion dated 27 August 2012. The author claims that Article 30(1) of the proposed regulation should be declared to be partly (i.e. in relation to the scope of regulation) inconsistent with Article 39 of the Constitution. He points out that the Constitution establishes a prohibition against medical experimentation on the human subject (and this notion includes clinical trials referred to in the proposed regulation) without his personal and prior consent. No limitation of this right is allowed, except for when it collides with other “equivalent” constitutional values, especially the right to life protection (Article 38 of the Constitution) and the right to health protection (Article 68 of the Constitution).
2
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Opinia na temat projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE

100%
Wróbel W.
Zeszyty Prawnicze BAS
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2012
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issue 4(36)
99-106
EN
The main subject of the analysis is the question of conformity with Poland’s Constitution of the possibility of carrying out clinical trials on minors. The author concludes that the provisions of Article 31 of the proposed regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, providing for the possibility of conducting clinical trials on minors, which are not aimed to be delivered for health benefit of those persons, are inconsistent with Article 39 of the Constitution of the Republic of Poland.
3
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Journey so far with COVID 19 – a comprehensive review

100%
Sayak Roy S.
European Journal of Clinical and Experimental Medicine
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2020
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issue 4
303-317
EN
Introduction. The occurrence of the severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has emerged as a global pandemic with huge death tolls. Coronavirus disease 2019 (COVID-19) may progress from minimal infection to serious respiratory failure mandating treatment for a continuum of developed disease condition. Aim. The purpose of this review is to summarize the findings related to epidemiology, clinical manifestations, modes of transmission, diagnosis and the treatment modalities (both experimental and repurposed) for COVID-19. Material and methods. Literature were searched using various search engines like PubMed, SCOPUS, EMBASE, J-Gate, Google Scholar to look for review articles, randomized controlled trial results, prospective studies and, retrospective studies done on COVID-19 for the purpose of this comprehensive review. Analysis of the literature. The transmission seems to be occurring through droplet, fomite and aerosols (rarely). Currently there is no specific/targeted vaccine available. Priority is highly placed to identify possible treatment approaches to circumvention this disease. Conclusion. Till we find a vaccine, we have to strategize to optimally use the existing evidence of the indirect effects of these various available drugs for therapy and maintain a strict protocol for prevention and we must use triage system to admit only those critically ill or having severe disease.
4
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LEGAL ASPECTS OF CLINICAL TRIALS IN POLAND

100%
Syroka-Marczewska K.
Review of European and Comparative Law
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2017
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vol. 28
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issue 1
67-84
EN
A clinical trial is each trial conducted in humans to discover or confirm the clinical, pharmacological, including pharmacodynamic, effects of action of one or more investigational medicinal products, or to identify the adverse reactions to one or more investigational medicinal products, or to monitor absorption, distribution, metabolism and excretion of one or more investigational medicinal products, taking into consideration their safety and efficacy. It ought to be remembered that clinical trials may be conducted with the use of medicinal products. Clinical trials must be conducted in a way which is in line with the primary principle that clinical trial participants’ rights, safety, health, and welfare override the interest of science and society.
5
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Opinia prawna w sprawie zgodności z Konstytucją RP projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi

100%
Banaszak B.
Zeszyty Prawnicze BAS
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2012
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issue 4(36)
107-117
EN
The purpose of the opinion is not to examine thoroughly the proposal for a regulation but only to assess the legal basis for its issue, and to provide an analysis of those provisions of the proposal that may raise doubts about their conformity with the Constitution of the Republic of Poland. The main conclusions of the opinion relate to the lack of grounds for delegation by the Republic of Poland to the bodies of the European Union of the competence to regulate the issue of clinical trials on medicinal products for human use under primary law of the EU. Such delegation would infringe Article 90(1) of the Constitution. The author claims that the time limits specified in the proposal for regulation for action of the State make it impossible for Polish public authorities to implement obligations resulting from the preamble to the Constitution and their duties relating to protection of individual’s rights referred to in its Article 30.
6
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From business to clinical trials: a systematic review of the literature on fraud detection methods to be used in central statistical monitoring

88%
Fronc M., Jakubczyk M.
Przegląd Statystyczny
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2022
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vol. 69
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issue 3
1-22
EN
Data-driven decisions can be suboptimal when the data are distorted by fraudulent behaviour. Fraud is a common occurrence in finance or other related industries, where large datasets are handled and motivation for financial gain may be high. In order to detect and the prevent fraud, quantitative methods are used. Fraud, however, is also committed in other circumstances, e.g. during clinical trials. The article aims to verify which analytical fraud-detection methods used in finance may be adopted in the field of clinical trials. We systematically reviewed papers published over the last five years in two databases (Scopus and the Web of Science) in the field of economics, finance, management and business in general. We considered a broad scope of data mining techniques including artificial intelligence algorithms. As a result, 37 quantitative methods were identified with the potential of being fit for application in clinical trials. The methods were grouped into three categories: pre-processing techniques, supervised learning and unsupervised learning. Our findings may enhance the future use of fraud-detection methods in clinical trials.
7
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Karta praw osób starszych dotycząca ich udziału w badaniach klinicznych

75%
Szczerbińska K., Zalewski Z., Oristrell Salvà J.
Zdrowie Publiczne i Zarządzanie
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2011
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vol. 9
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issue 1
119-127
EN
The results of initial literature review indicate that elderly persons are underrepresented in the clinical trials on which clinical recommendations are based. This gave stimulus to perform the ‘Increasing the PaRticipation of the ElDerly In Clinical Trials’ (PREDICT) project, financed by the EU within the FP7. The goal of the PREDICT was to study reasons why older people are excluded from clinical trials based on age-related criteria and development of the charter including recommendations to prevent their exclusion. The project gathered investigators from 11 institutions in 9 countries: Czech Republic, Israel, Italy, Lithuania, the Netherlands, Poland, Romania, Spain, and the UK. Within the scope of PREDICT, first, to assess the scope of the problem the systematic review of literature was performed, then the opinion shared by the health care professionals, ethicists, and representatives of pharmaceutical industry on the possible reasons of underrepresentation of old people in trials was examined, then finally the opinion of elderly patients and their caregivers were assessed. The analysis of gathered data enabled creation of PREDICT charter which contains recommendations aiming to increase the participation of elderly people in clinical trials
8
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Opinia w sprawie projektu rozporządzenia Parlamentu Europejskiego i Rady w sprawie badań klinicznych produktów leczniczych stosowanych u ludzi oraz uchylenia dyrektywy 2001/20/WE

75%
Bosek L., Olejniczak D.
Zeszyty Prawnicze BAS
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2012
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issue 4(36)
118-148
EN
The purpose of the opinion is to examine thoroughly the proposal for a regulation of the European Parliament and of the Council on clinical trials on medicinal products for human use. Presently, the issue of clinical trials is regulated differently in particular EU member states, due to their different legal traditions and constitutional standards. By allowing for experimentation on human beings without their knowledge or consent, the proposed regulation substantially infringes the principles of subsidiarity, proportionality and conferred competences, as well as human dignity and the right to integrity of the person guaranteed by Articles 1 and 3 of the Charter of Fundamental Rights of the European Union. These circumstances sufficiently justify initiation by the Polish Sejm of the procedure specified in Article 6 of Protocol 2 on the application of the principles of subsidiarity and proportionality annexed to the Lisbon Treaty.
9
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Ubezpieczenie odpowiedzialności cywilnej jako metoda zarządzania rynkiem w badaniach klinicznych produktu leczniczego

75%
Piechota A., Uniwersytet Łódzki K. U.
Acta Universitatis Lodziensis. Folia Oeconomica
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2013
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vol. 296
EN
According to polish legislation, regulations concerning clinical trials are different for therapeutic products than for medical products, equipment of the medical device or active implantable medical devices. This article discusses the regulations concerning the registration of medicines, particularly the civil liability of the researcher’s and the sponsorʼs responsibility in case of conducting the clinical trials of the therapeutic product. Also, there are presented the risks and threats for the agents involved in the clinical trial, including the clinical trial participant, as this person takes the risk for unwanted of medical product intake.
PL
W ustawodawstwie polskim regulacja badań klinicznych jest odrębna dla produktów leczniczych oraz dla wyrobów medycznych, wyposażenia wyrobu medycznego lub aktywnego wyrobu medycznego do implantacji. W niniejszym artykule omówione zostały regulacje dotyczące rejestracji leków, w szczególności odpowiedzialności cywilnej badacza i sponsora w przypadku przeprowadzania badań klinicznych produktu leczniczego. Ponadto przybliżone zostały ryzyka i zagrożenia stron badania klinicznego, w tym uczestnika badania klinicznego jako podejmującego ryzyko związane z ewentualnym wystąpieniem zdarzeń niepożądanych badanego produktu leczniczego.
10
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Wpływ przepisów prawa Unii Europejskiej o badaniach klinicznych produktów leczniczych na polskie prawo karne

75%
Gałązka M.
Forum Prawnicze
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2020
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issue 2 (58)
56–75
EN
The article raises the question of the influence of the EU clinical trials of medicinal products legislation on the Polish criminal law. Although this issue does not fall within the scope of the Article 83 of the Treaty on Functioning of the European Union, its significant importance results from the expected beginning of application of the Regulation No. 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC. The impact of the EU legislation on member states’ criminal law in the field of clinical trials is based on the principle of pri- macy. Three directions of this impact can be distinguished concerning Regulation No. 536/2014. The first is the exclusion of the unlawfulness of the acts prohibited by the chapter 19 of the Polish Criminal Code within the scope of the prerequisites for the admissibility of clinical trials. The second is the de facto depenalisation of the behaviors described by in Article 126a (1) (3–5) of Pharmaceutical Act. The indicated two effects may take place ex lege with the beginning of application of Regulation No. 536/2014, if there is no change in the Polish law beforehand. The realisation of the third direction depends on the decision of the Polish legislator, who is required to introduce effective, proportionate and dissuasive penalties applicable to infringements of the Regulation No. 536/2014. The type of these measures is left to the discretion of the member states, but the current legal situation combined with the principle of assimilation prompts us to suppose that the choice of criminal penalties will be sustained.
11
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Badania kliniczne wyrobów medycznych wykorzystujących inteligentne algorytmy – wstęp do dyskusji

63%
Stelmasiak K., Świerczyński M., Więckowski Z.
Prawo w Działaniu
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2022
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issue 50
112-129
EN
The authors of the paper carry out a preliminary assessment of the new regulation on clinical trials of medical devices in the context of software based on intelligent algorithms (so-called AI systems). The primary source of law here is the EU Medical Device Regulation (MDR). The study highlights the need to take into account the regulations on artificial intelligence systems when conducting clinical trials. It is justified by their close relationship with the EU provisions on medical devices. The main difficulty in making a legal and ethical assessment of new solutions used in medical devices is the application of various, sometimes divergent, regulations in the field of new technologies and medical law. The study contains preliminary, necessarily balanced and careful, bearing in mind the need to protect patients - research participants (and other people), conclusions on the application of the above provisions in the conduct of clinical trials.
PL
Autorzy przeprowadzają wstępną ocenę nowej regulacji o badaniach klinicznych wyrobów medycznych w kontekście oprogramowania opartego na inteligentnych algorytmach (tzw. systemów AI). Podstawowym źródłem prawa jest unijne rozporządzenie o wyrobach medycznych (Medical Device Regulation). W opracowaniu zwrócono uwagę na potrzebę uwzględnienia regulacji dotyczących systemów sztucznej inteligencji przy prowadzeniu badań klinicznych. Jest to uzasadnione ich ścisłym związkiem z przepisami unijnymi o wyrobach medycznych. Podstawową trudność przy dokonaniu oceny prawnej oraz etycznej nowych rozwiązań stosowanych w wyrobach medycznych sprawia zastosowanie różnych, czasem rozbieżnych przepisów z dziedziny nowych technologii oraz prawa medycznego. Opracowanie zawiera wstępne, z konieczności zbalansowane i ostrożne, z uwagi na potrzebę ochrony pacjentów – uczestników badań (oraz innych osób), wnioski w zakresie stosowania powyższych przepisów podczas prowadzenia badań klinicznych.
12
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Rola firm farmaceutycznych w udostępnianiu tanich leków dobrej jakości w krajach rozwijających się

51%
Soniewicka M.
Prakseologia
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2012
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issue 153
315-336
EN
Using the example of a global pharmaceutical industry, I examine the role of private companies in fulfilling social aims. I address the problem of aid in the context of availability of affordable and safe medicines in developing countries, which is one aspect of fulfilling the right to health. Are the mechanisms of free market and philanthropic actions of pharmaceutical companies sufficient to guarantee essential medicines to the most vulnerable inhabitants of the world? Are international pharmaceutical concerns obliged to guarantee human rights only or to deliver human rights, in particular the right to health, as well? The article presents the conflict of interests between profit-driven pharmaceutical industry and ethically-driven public health, which can be fully addressed only by certain legal regulations. The thesis argued in the article is that free market itself cannot solve its failures (such as undersupply of innovations, undersupply of non-beneficial medicines, monopolistic policies and pricing); to solve the problem it is required to set up public institutions and legal regulations of both local and global scope. Neither free market, nor benevolent aid actions of pharmaceutical companies can address the problem of health care in developing countries, where the lack of medicines is a small aspect of a much broader and intricate problem of poverty and the weakness of state institutions which are not responsive to the basic needs of its citizens.
13
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Leki weterynaryjne jako produkty lecznicze w rozumieniu ustawy – Prawo farmaceutyczne. Zagadnienia wybrane

38%
Kaczan D.
Studia Prawnicze
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2019
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issue 2 (218)
45-64
EN
The principles of conducting clinical trials, the marketing authorization procedure, manufacturing, importing, advertising and marketing of veterinary medicinal products are often secondary subjects of interest of pharmaceutical law doctrine’s representatives. It is difficult to criticize it, because of the priority importance of patients’ protection and the significant similarity of relevant regulations to regulations governing the functioning of the market of medicines for people. However, this problem should not be ignored. Medicines used in veterinary medicine may pose a threat not only to animals, but also to people applying them, consumers of food of animal origin and the environment. The aim of the article is to research mentioned matter in this context, taking into account the requirement of conciseness of the legal text. The following methods were used: dogmatic, axiological and comparative.
PL
Zasady prowadzenia badań klinicznych, postępowania w sprawie dopuszczenia do obrotu, wytwarzania, importu, reklamy i obrotu weterynaryjnymi produktami leczniczymi często stanowią drugorzędny przedmiot zainteresowania przedstawicieli doktryny prawa farmaceutycznego. Trudno to krytykować ze względu na priorytetowe znaczenie ochrony życia i zdrowia pacjentów oraz znaczne podobieństwo stosownych unormowań do przepisów regulujących funkcjonowanie rynku leków przeznaczonych dla ludzi. Problematyki owej nie należy jednak pomijać. Medykamenty stosowane w weterynarii mogą zagrażać nie tylko zwierzętom, ale i aplikujących je osobom, konsumentom żywności pochodzenia zwierzęcego oraz środowisku naturalnemu. Celem artykułu jest zbadanie wybranej materii w tym kontekście z uwzględnieniem postulatu zwięzłości tekstu prawnego. Wykorzystano w związku z tym metody: dogmatyczną, aksjologiczną i prawno-porównawczą.
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