Clinical Trials, Data Protection and Patient Empowerment in the Era of the New EU Regulations

Public Health Genomics

Volumn 18, Issue 6, 2015, Pages 386-395

  Negrouk, Anastassia ^a   Horgan, Denis ^b   Gorini, Alessandra ^c   Cutica, Ilaria ^c   Leyens, Lada ^e   Schee Genannt Halfmann, Sebastian ^e   Pravettoni, Gabriella ^d  

^a EORTC DATA CENTER   (Belgium)

^b European Alliance for Personalised Medicine   (Belgium)

^c UNIVERSITY OF MILAN   (Italy)

^d EUROPEAN INSTITUTE OF ONCOLOGY   (Italy)

^e MAASTRICHT UNIVERSITY   (Netherlands)

Author keywords

Clinical trials; Data protection; EU regulations; Patient empowerment

Indexed keywords

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; EUROPEAN UNION; GENETICS; INFORMATION PROCESSING; LEGISLATION AND JURISPRUDENCE; NEOPLASMS; PATIENT PARTICIPATION; STANDARDS; TRENDS;

BIOMEDICAL RESEARCH; CLINICAL TRIALS AS TOPIC; COMPUTER SECURITY; CONFIDENTIALITY; DATASETS AS TOPIC; EUROPEAN UNION; HUMANS; NEOPLASMS; PATIENT PARTICIPATION; PRECISION MEDICINE;

EID: 84952876066     PISSN: 16624246     EISSN: 16628063     Source Type: Journal    
DOI: 10.1159/000441561     Document Type: Article

References (37)

1. European Commission: Research and innovation. 2015. http://ec.europa.eu/research/index. cfm.
2. US Food and Drug Administration: Table of pharmacogenomic biomarkers in drug labeling. 2015. http://www.fda.gov/drugs/scienceresearch/researchareas/pharmacogenetics/ucm083378.htm.
3. McKinsey & Company: Personalized medicine-the path forward. 2013.
4. European Parliament; 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. Off J Eur Union 2014; 57: 1-76.
5. European Parliament: Clinical trials: clearer rules, better protection for patients. European Parliament News, April 2014. http://www.europarl.europa.eu/news/en/news-room/content/20140331IPR41186/html/Clinicaltrials-clearer-rules-better-protection-forpatients.
6. Hirschler B: Europe backs more transparent, simpler clinical trial rules. Reuters, 2014.
7. European Medicines Agency: European Medicines Agency policy on publication of clinical data for medicinal products for human use. London, European Medicines Agency, 2014. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2014/10/WC500174796.pdf.
8. European Federation of Pharmaceutical Industries and Associations: Joint EFPIAPhRMA principles for responsible clinical trial data sharing become effective. 2014. http://www.efpia.eu/mediaroom/132/43/Joint-EFPIA-PhRMA-Principles-for-Responsible-Clinical-Trial-Data-Sharing-Become-Effective-Today.
9. European Medicines Agency: European Medicines Agency receives interim decisions of the General Court of the EU on access to clinical and non-clinical information. London, European Medicines Agency, 2013. http://www.ema.europa.eu/docs/en-GB/document-library/Press-release/2013/04/WC500142837.pdf.
10. European Medicines Agency: Access to clinical-trial data and transparency: workshop report. 2012. http://www.ema.europa.eu/docs/en-GB/document-library/Report/2012/12/WC500135841.pdf.
11. European Parliament; European 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. Off J Eur Commun 2001; 44: 43-48.
12. European Medicines Agency: Rules for the implementation of regulation (EC) No 1049/2001. London, European Medicines Agency, 2006. http://www.ema.europa.eu/docs/en-GB/document-library/Other/2010/02/WC500070829.pdf.
13. European Medicines Agency: Annual reports and work programmes. 2014. http://www.ema.europa.eu/ema/index.jsp?curl=pages/about-us/document-listing/document-listing- 000208.jsp&mid=WC0b01ac058002933 a#section2.
14. European Medicines Agency: Publication of clinical reports-EMA adopts landmark policy to take effect on 1 January 2015. 2014. http://www.ema.europa.eu/ema/?curl=pages/news-and-events/news/2014/10/news-detail- 002181.jsp&mid=WC0b01ac058004d5c1.
15. PatientsLikeMe: Live better, together! 2015. https://www.patientslikeme.com/.
16. CART-WHEEL Center for Analysis of Rare Tumors: Projects supported by CARTWHEEL. 2015. https://www.cart-wheel.org/page/15/research.
17. e cancer: EORTC and the management of clinical trial data. 2014. http://ecancer.org/video/3142/eortc-and-the-management-of-clinicaltrial-data.php.
18. European Patients' Forum: European Commission's proposal for a general data protection regulation-EPF position statement. 2012. http://www.datasaveslives.eu/media/1110/general-data-protection-regulationposition-statement-final.pdf.
19. e cancer: Financial impact of a cancer diagnosis by Prof Françoise Meunier. 2014. http://ecancer.org/video/3137/financial-impact-ofa-cancer-diagnosis.php.
20. Robinson A, Thomson R: Variability in patient preferences for participating in medical decision making: implication for the use of decision support tools. Qual Health Care 2001; 10(suppl 1):i34-i38.
21. European Alliance for Personalised Medicine: Innovation and patient access to personalised medicine. Brussels, European Alliance for Personalised Medicine, 2013. http://euapm.eu/pdf/EAPM-REPORT-on-Innovation- and-Patient-Access-to-Personalised- Medicine.pdf.
22. Mead N, Bower P: Patient-centred consultations and outcomes in primary care: a review of the literature. Patient Educ Couns 2002; 48: 51-61.
23. Sørensen K, Van den Broucke S, Pelikan JM, Fullam J, Doyle G, Slonska Z, Kondilis B, Stoffels V, Osborne RH, Brand H: Measuring health literacy in populations: illuminating the design and development process of the European Health Literacy Survey Questionnaire (HLS-EU-Q). BMC Public Health 2013; 13: 948.
24. Charles C, Gafni A, Whelan T: Decisionmaking in the physician-patient encounter: revisiting the shared treatment decision-making model. Soc Sci Med 1999; 49: 651-661.
25. Mossman J, Boudioni M, Slevin M: Cancer information: a cost-effective intervention. Eur J Cancer 1999; 35: 1587-1591.
26. HLS-EU Consortium: Comparative report of health literacy in eight EU member states. 2012. http://www.google.ch/url?sa=t&rct=j&q=&esr c=s&source=web&cd=1&ved=0CCAQFjAAa hUKEwib6ZeYmNjIAhUKWRQKHQEXBr0 &url=http%3A%2F%2Fwww.maastrichtuniversity. nl%2Fweb%2Ffile%3Fuuid%3Dd101b 63c-dbbe-472d-971f-7a4eae14ba47% 26owner%3Dd5b3681e-fc4a-476e-b9ff-a807c2 6760b9&usg=AFQjCNEhvyI7FnCYt7htsE1P5 0YLwhFGeQ&bvm=bv.105841590,d.bGQ.
27. Downs JS, Bruine de Bruin W, Fischhoff B, Hesse B, Maibach E: How people think about cancer: a mental models approach; in Heath RL, O'Hair D (eds): Handbook of Risk and Crisis Communication. New York, Routledge, 2009, pp 507-524.
28. Coulter A, Ellins J: Effectiveness of strategies for informing, educating, and involving patients. BMJ 2007; 335: 24-27.
29. Kessels RP: Patients' memory for medical information. J R Soc Med 2003; 96: 219-222.
30. Henderson S: Power imbalance between nurses and patients: a potential inhibitor of partnership in care. J Clin Nurs 2003; 12: 501-508.
31. Harris K: The informational needs of patients with cancer and their families. Cancer Pract 1998; 6: 39-46.
32. Sudore RL, Schillinger D: Interventions to improve care for patients with limited health literacy. J Clin Outcomes Manag 2009; 16: 20-29.
33. McPherson CJ, Higginson IJ, Hearn J: Effective methods of giving information in cancer: a systematic literature review of randomized controlled trials. J Public Health Med 2001; 23: 227-234.
34. Gustafson DH, Hawkins RP, Boberg EW, 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. Int J Med Inform 2002; 65: 169-177.
35. Grilli R, Ramsay C, Minozzi S: Mass media interventions: effects on health services utilisation. Cochrane Database Syst Rev 2002; 1:CD000389.
36. Meunier F: Society needs to ensure that cancer survivors can get their lives back. Financial Times, Sept 26, 2014.
37. European Commission: Innovation in Healthcare: From Research to Market, Brussels, 2011.