Abstract
Original language | English |
---|---|
Pages (from-to) | 386-395 |
Number of pages | 10 |
Journal | Public Health Genomics |
Volume | 18 |
Issue number | 6 |
DOIs | |
Publication status | Published - 2015 |
JEL classifications
- i18 - "Health: Government Policy; Regulation; Public Health"
Keywords
- Clinical trials
- Data protection
- EU regulations
- Patient empowerment
- Article
- clinical trial (topic)
- computer security
- confidentiality
- data protection
- doctor patient relation
- empowerment
- Europe
- health care policy
- health literacy
- health personnel attitude
- health practitioner
- human
- medical information
- medical research
- patient information
- patient right
- personalized medicine
- priority journal
- privacy
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In: Public Health Genomics, Vol. 18, No. 6, 2015, p. 386-395.
Research output: Contribution to journal › Article › Academic › peer-review
TY - JOUR
T1 - Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations
AU - Negrouk, A.
AU - Horgan, D.
AU - Gorini, A.
AU - Cutica, I.
AU - Leyens, L.
AU - Schee Genannt Halfmann, S.
AU - Pravettoni, G.
N1 - Export Date: 25 May 2016 CODEN: COGEF Correspondence Address: Negrouk, A.; Department of International Policy Office, EORTC IRB, Avenue E. Mounier 83/11, Belgium; email: anastassia.negrouk@eortc.be References: (2015) Research and Innovation, , http://ec.europa.eu/research/index.cfm, European Commission; (2015) Table of Pharmacogenomic Biomarkers in Drug Labeling, , http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm, US Food and Drug Administration; (2013) Personalized Medicine-The Path Forward, , McKinsey & Company; European Council Regulation (EU) 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 (2014) Off J Eur Union, 57, pp. 1-76. , European Parliament; Clinical trials clearer rules, better protection for patients (2014) European Parliament News, , http://www.europarl.europa.eu/news/en/news-room/content/20140331IPR41186/html/Clinicaltrials-clearer-rules-better-protection-forpatients, European Parliament April; Hirschler, B., (2014) Europe Backs More Transparent, Simpler Clinical Trial Rules, , Reuters; (2014) European Medicines Agency Policy on Publication of Clinical Data for Medicinal Products for Human Use, , http://www.ema.europa.eu/docs/en_GB/document_library/Other/2014/10/WC500174796.pdf, European Medicines Agency. London, European Medicines Agency; (2014) Joint EFPIAPhRMA Principles for Responsible Clinical Trial Data Sharing Become Effective, , http://www.efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Responsible-Clinical-Trial-Data-Sharing-Become-Effective-Today, European Federation of Pharmaceutical Industries and Associations; (2013) European Medicines Agency Receives Interim Decisions of the General Court of the EU on Access to Clinical and Non-clinical Information, , http://www.ema.europa.eu/docs/en_GB/document_library/Press_release/2013/04/WC500142837.pdf, European Medicines Agency. London, European Medicines Agency; (2012) Access to Clinical-trial Data and Transparency: Workshop Report, , http://www.ema.europa.eu/docs/en_GB/document_library/Report/2012/12/WC500135841.pdf, European Medicines Agency; Council Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (2001) Off J Eur Commun, 44, pp. 43-48. , European Parliament European; Rules for the implementation of regulation (EC) No 1049/2001 (2006) London, European Medicines Agency, , http://www.ema.europa.eu/docs/en_GB/document_library/Other/2010/02/WC500070829.pdf, European Medicines Agency; (2014) Annual Reports and Work Programmes, , http://www.ema.europa.eu/ema/index.jsp?curl=pages/about_us/document_listing/document_listing_000208.jsp&mid=WC0b01ac058002933a#section2, European Medicines Agency; (2014) Publication of Clinical Reports-EMA Adopts Landmark Policy to Take Effect on, , http://www.ema.europa.eu/ema/?curl=pages/news_and_events/news/2014/10/news_detail_002181.jsp&mid=WC0b01ac058004d5c1, European Medicines Agency 1 January 2015; (2015) Live Better, Together, , https://www.patientslikeme.com/, PatientsLikeMe; (2015) Projects Supported by CARTWHEEL, , https://www.cart-wheel.org/page/15/research, CART-WHEEL Center for Analysis of Rare Tumors; (2014) EORTC and the Management of Clinical Trial Data, , http://ecancer.org/video/3142/eortc-and-the-management-of-clinicaltrial-data.php, e cancer; (2012) European Commission's Proposal for A General Data Protection Regulation-EPF Position Statement, , http://www.datasaveslives.eu/media/1110/general-data-protection-regulationposition-statement-final.pdf, European Patients' Forum; (2014) Financial Impact of A Cancer Diagnosis by Prof Françoise Meunier, , http://ecancer.org/video/3137/financial-impact-ofa-cancer-diagnosis.php, e cancer; Robinson, A., Thomson, R., Variability in patient preferences for participating in medical decision making: Implication for the use of decision support tools (2001) Qual Health Care, 10, pp. i34-i38; (2013) Innovation and Patient Access to Personalised Medicine, , http://euapm.eu/pdf/EAPM_REPORT_on_Innovation_and_Patient_Access_to_Personalised_Medicine.pdf, European Alliance for Personalised Medicine Brussels, European Alliance for Personalised Medicine; Mead, N., Bower, P., Patient-centred consultations and outcomes in primary care: A review of the literature (2002) Patient Educ Couns, 48, pp. 51-61; Sørensen, K., Van Den Broucke, S., Pelikan, J.M., Fullam, J., Doyle, G., Slonska, Z., Kondilis, B., Brand, H., Measuring health literacy in populations: Illuminating the design and development process of the European Health Literacy Survey Questionnaire (HLS-EU-Q) (2013) BMC Public Health, 13, p. 948; Charles, C., Gafni, A., Whelan, T., Decisionmaking in the physician-patient encounter: Revisiting the shared treatment decision-making model (1999) Soc Sci Med, 49, pp. 651-661; Mossman, J., Boudioni, M., Slevin, M., Cancer information: A cost-effective intervention (1999) Eur J Cancer, 35, pp. 1587-1591; (2012) Comparative Report of Health Literacy in Eight EU Member States, , http://www.google.ch/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=0CCAQFjAAahUKEwib6ZeYmNjIAhUKWRQKHQEXBr0&url=http%3A%2F%2Fwww.maastrichtuniversity.nl%2Fweb%2Ffile%3Fuuid%3Dd101b63c-dbbe-472d-971f-7a4eae14ba47%26owner%3Dd5b3681e-fc4a-476e-b9ff-a807c26760b9&usg=AFQjCNEhvyI7FnCYt7htsE1P50YLwhFGeQ&bvm=bv.105841590,d.bGQ; Downs, J.S., Bruine De Bruin, W., Fischhoff, B., Hesse, B., Maibach, E., How people think about cancer: A mental models approach (2009) Handbook of Risk and Crisis Communication, pp. 507-524. , n Heath RL, O'Hair D (eds). New York, Routledge; Coulter, A., Ellins, J., Effectiveness of strategies for informing, educating, and involving patients (2007) BMJ, 335, pp. 24-27; Kessels, R.P., Patients' memory for medical information (2003) J R Soc Med, 96, pp. 219-222; Henderson, S., Power imbalance between nurses and patients: A potential inhibitor of partnership in care (2003) J Clin Nurs, 12, pp. 501-508; Harris, K., The informational needs of patients with cancer and their families (1998) Cancer Pract, 6, pp. 39-46; Sudore, R.L., Schillinger, D., Interventions to improve care for patients with limited health literacy (2009) J Clin Outcomes Manag, 16, pp. 20-29; McPherson, C.J., Higginson, I.J., Hearn, J., Effective methods of giving information in cancer: A systematic literature review of randomized controlled trials (2001) J Public Health Med, 23, pp. 227-234; Gustafson, D.H., Hawkins, R.P., Boberg, E.W., Mc-Tavish, F., Owens, B., Wise, M., Berhe, H., Pingree, S., Chess: 10 years of research and development in consumer health informatics for broad populations, including the underserved (2002) Int J Med Inform, 65, pp. 169-177; Grilli, R., Ramsay, C., Minozzi, S., Mass media interventions: Effects on health services utilisation (2002) Cochrane Database Syst Rev, 1, p. CD000389; Meunier, F., Society needs to ensure that cancer survivors can get their lives back Financial Times, Sept 26, 2014; (2011) Innovation in Healthcare: From Research to Market, , European Commission, Brussels
PY - 2015
Y1 - 2015
N2 - Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine. © 2015 S. Karger AG, Basel. All rights reserved.
AB - Cancer clinical trials and, in general, cancer clinical research by definition need a multi-modality approach. It is not enough to discover and register new drugs. To get cancer under control requires us to perform complex clinical studies that integrate drugs, companion diagnostics, new or improved surgical procedures and new radiotherapy approaches as well as, most importantly, to integrate all available information. This includes biological material and, of increasing importance, large amounts of data using big data technologies. To personalise treatment, genetic data are more and more frequently used. Therefore, the general approach is holistic. Legislators, on the other hand, work in a silo mentality; the needs of clinical research are poorly understood, and legislation focuses on either health care or the commercialisation of a product, and not on clinical research. In the last 2 years the EU has drafted several major regulations touching on clinical trials, in vitro diagnostics, medical devices and data protection, all of which will impact clinical research, although the silo mentality makes the overall framework inconsistent and potentially highly damaging to the EU's capacity to make rapid progress in the field of personalised medicine. © 2015 S. Karger AG, Basel. All rights reserved.
KW - Clinical trials
KW - Data protection
KW - EU regulations
KW - Patient empowerment
KW - Article
KW - clinical trial (topic)
KW - computer security
KW - confidentiality
KW - data protection
KW - doctor patient relation
KW - empowerment
KW - Europe
KW - health care policy
KW - health literacy
KW - health personnel attitude
KW - health practitioner
KW - human
KW - medical information
KW - medical research
KW - patient information
KW - patient right
KW - personalized medicine
KW - priority journal
KW - privacy
U2 - 10.1159/000441561
DO - 10.1159/000441561
M3 - Article
C2 - 26565798
SN - 1662-4246
VL - 18
SP - 386
EP - 395
JO - Public Health Genomics
JF - Public Health Genomics
IS - 6
ER -