PROFILING IN THE RECRUITMENT OF SUBJECTS FOR CLINICAL TRIALS IN THE LIGHT OF GDPR
| Autor: | Natalia Domagała, Bartłomiej Oręziak, Marek Świerczyński |
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| Jazyk: | English<br />Italian<br />Polish |
| Rok vydání: | 2020 |
| Předmět: | |
| Zdroj: | Zeszyty Prawnicze, Vol 20, Iss 2 (2020) |
| Druh dokumentu: | article |
| ISSN: | 1643-8183 2353-8139 |
| DOI: | 10.21697/zp.2020.20.2.14 |
| Popis: | Highly specialized methods of selecting participants for clinical trials have been in use for a long time in the medical sciences. An example is offered by oncological pre-profling, which involves the use of genetic biomarkers for a preliminary identification of oncological patients for clinical trials. We should expect further developments in this area, due to the rapid progress being made in e-health technologies and patients’ growing use of mobile applications. Failure to use new technologies in recruitment could even lead to failure in carrying out a clinical trial due to a shortage of participants. This issue is particularly important due to the regulatory framework for profiling adopted under GDPR (the General Data Protection Regulation). GDPR is of crucial importance for the R&D activities pursued by the pharmaceutical industry and in personalized medicine, and one of the biggest challenges is the practical application of its rules in profiling activities. Te same applies to the use of data obtained during clinical trials at the stage when the medical product is about to be launched on the market. The aim of this paper is to present the GDPR rules to facilitate the use of profiling tools for the recruitment of participants for clinical trials. It includes a proposal for the amendment of the EU pharmaceutical law to introduce statutory grounds for profiling. |
| Databáze: | Directory of Open Access Journals |
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