PROFILING IN THE RECRUITMENT OF SUBJECTS FOR CLINICAL TRIALS IN THE LIGHT OF GDPR

Natalia  Domagała; Bartłomiej Oręziak; Marek Świerczyński

doi:10.21697/zp.2020.20.2.14

Opublikowane: 2020-07-30

Tom 20 Nr 2 (2020)

PROFILING IN THE RECRUITMENT OF SUBJECTS FOR CLINICAL TRIALS IN THE LIGHT OF GDPR

Natalia Domagała

, Bartłomiej Oręziak

, Marek Świerczyński

Zeszyty Prawnicze

Dział: Artykuły

https://doi.org/10.21697/zp.2020.20.2.14

Abstrakt

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.

Słowa kluczowe:

clinical trials; personal data; profling; recruitment; GDPR.

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Zasady cytowania

Domagała, N. ., Oręziak, B., & Świerczyński, M. (2020). PROFILING IN THE RECRUITMENT OF SUBJECTS FOR CLINICAL TRIALS IN THE LIGHT OF GDPR. Zeszyty Prawnicze, 20(2), 265–280. https://doi.org/10.21697/zp.2020.20.2.14

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Bibliografia

Barta, P., Kawecki., M., and Litwiński , P., Rozporządzenie UE w sprawie ochrony osób fizycznych w związku z przetwarzaniem danych osobowych i swobodnym przepływem takich danych. Komentarz, Warszawa: Wydawnictwo C. H. Beck, 2018.
Google Scholar

Blume, P., Data Protection and Privacy – Basic Concepts in a Changing World, «Scandinavian Studies in Law» 56/2010, p. 151-164.
Google Scholar

Bygrave, L., Data Protection Law: Approaching Its Rationale, Logic and Limits, The Hague: Kluwer, 2002.
Google Scholar

Bygrave, L., Data Privacy Law: An International Perspective, Oxford: O.U.P. 2014.
Google Scholar

Caduff-Janosa, P., Lost in Regulation, [in] Pharmacovigilance. Critique and Ways Forward, I. Edwards, and M. Lindquist (eds.), Basel: Springer 2017, p. 9-19.
Google Scholar

Chomiczewski, W., Czerniawski, M., Drobek, et al., RODO. Ogólne rozporządzenie o ochronie danych. Komentarz, Warszawa: Wolters Kluwer, 2017.
Google Scholar

Chowdhury, A., and Gaigl, A., Te Economics of Competition Law and of Pharmaceutical Patents, [in] Competition and Patent Law in the Pharmaceutical Sector: An International Perspective, G. Pitruzzella and G. Muscolo (eds.), Alphen aan den Rijn: Wolters Kluwer, 2016, p. 5-14.
Google Scholar

Crossley, S., EU Regulation on health information technology, software and mobile apps, [in] Life Sciences: A Global Guide from Practical Law, ed. S. Fellows, I, 2016, https://uk.practicallaw.thomsonreuters.com/26195533?transitionType=Default&contextData=(sc.Default)&frstPage=true&bhcp=1 (accessed 3 January 2019).
Google Scholar

Ferraris, V., Bosco, F., Cafiero, G., D’Angelo, E., Suloyeva, Y., and Koops, B.J., Defining profiling, https://papers.ssrn.com/sol3/papers.cfm?abstract_id=2366564 (accessed 5 February 2020).
Google Scholar

Gayo, M., Protección de datos personales e innovación: (in)Compatibles? Madrid: Editorial Reus S.A., 2016.
Google Scholar

Härting N., Big Data und Profling nach der DSGVO, «ITRB» 2016, p. 209-211.
Google Scholar

Hildebrandt, M., Profling and the rule of law, «Identity in the Information Society» 1.1/2008, p. 55-70.
Google Scholar

Ince , B., Cuijpers, P., Hof, E., and Riper, H., Reaching and recruiting Turkish migrants for a clinical trial through Facebook: A process evaluation, «Internet Interventions» 1.2/2014, p. 74-83.
Google Scholar

Laurie, F., L’innovation et l’échange de données numériques, [in :] L’innovation a l’épreuve de la mondialisation, ed. P. Cervetti, Marseille: P.U.A.M., p. 87-106.
Google Scholar

Reyes, F., Recherche clinique et prise en compte l’innovation, [in] Traité de santé publique,. F. Bourdillor, G. Brucker, and D. Tabuteau (eds.), Paris: Bayard, 2007,p. 263-273.
Google Scholar

Różyńska, J., Ocena ryzyka i korzyści badania biomedycznego, [in] Badania naukowe z udziałem ludzi w biomedycynie. Standardy międzynarodowe, J.Różyńska and M. Waligóra (eds.), Warszawa: Lex a Wolters Kluwer business, 2012, p. 65-85.
Google Scholar

Rustici, C., GDPR Profling and Business Practice, «Computer Law Review International» 2/2018, p. 34-43.
Google Scholar

Servent, A., Protecting or Processing?, [in:] Data Protection and Cybersecurity in Europe, W. Schünemann and M. Baumann (eds.), Cham: Springer, 2005, p. 115-130.
Google Scholar

Stempel, D., What the ISCHEMIA Controversy Tells Us About Patient Recruitment in Clinical Trials, Medical Marketing Insights https://www. mdconnectinc.com/medical-marketing-insights/ischemia-controversy-patient-recruitment-clinical-trials (accessed 3 January 2019).
Google Scholar

Wnukiewicz-Kozłowska, A., Eksperyment medyczny na organizmie ludzkim w prawie międzynarodowym i europejskim, Warszawa: ABC, 2004.
Google Scholar

Voigt, P., and von dem Bussche, A., The EU General Data Protection Regulation (GDPR). A Practical Guide, Cham: Springer, 2017.
Google Scholar

Yu, H., Achieving Proof of Concept in Drug Discovery and Development, Cheltenham: Elgar, 2017.
Google Scholar