European Society for Medical Oncology (ESMO)

…agents, where incremental data can help define best practice even if individual clinical trials may not always be practice changing. D. I. Quinn* Division of Medical Oncology, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, USA (*E-mail: [email protected]) disclosure The author has declared no conflicts of interest. references 1. Calvert AH, Harland SJ, Newell DR et al. Early clinical studies with cis-diammine- 1,1-cyclobutane dicarboxylate platinum II. Cancer Chemother Pharmacol 1982; 9: 140–147. 2. Curt GA, Grygiel JJ, Corden BJ et al. A phase I and pharmacokinetic study of diamminecyclobutane-dicarboxylatoplatinum (NSC 241240). Cancer Res 1983; 43: 4470–4473. 3. Calvert AH, Newell DR, Gumbrell LA et al. Carboplatin dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989; 7: 1748–1756.

…dosage: prospective evaluation of a simple formula based on renal function. J Clin Oncol 1989; 7: 1748–1756. 4. Bajorin DF, Sarosdy MF, Pfister DG et al. Randomized trial of etoposide and cisplatin versus etoposide and carboplatin in patients with good-risk germ cell tumors: a multiinstitutional study. J Clin Oncol 1993; 11: 598–606. 5. Nichols CR, Andersen J, Lazarus HM et al. High-dose carboplatin and etoposide with autologous bone marrow transplantation in refractory germ cell cancer: an Eastern Cooperative Oncology Group protocol. J Clin Oncol 1992; 10: 558–563. 6. Einhorn LH, Williams SD, Chamness A et al. High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors. N Engl J Med 2007; 357: 340–348.

A et al. High-dose chemotherapy and stem-cell rescue for metastatic germ-cell tumors. N Engl J Med 2007; 357: 340–348. 7. Feldman DR, Sheinfeld J, Bajorin DF et al. TI-CE high-dose chemotherapy for patients with previously treated germ cell tumors: results and prognostic factor analysis. J Clin Oncol 2010; 28: 1706–1713. 8. Agarwala AK, Perkins SM, Abonour R et al. Salvage chemotherapy with high-dose carboplatin and etoposide with peripheral blood stem cell transplant in patients with relapsed pure seminoma. Am J Clin Oncol 2011; 34: 286–288. 9. Oliver RT, Mead GM, Rustin GJ et al. Randomized trial of carboplatin versus radiotherapy for stage I seminoma: mature results on relapse and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214). J Clin Oncol 2011; 29: 957–962.

…and contralateral testis cancer rates in MRC TE19/EORTC 30982 study (ISRCTN27163214). J Clin Oncol 2011; 29: 957–962. 10. Cathomas R, Klingbiel D, Geldart TR et al. Relevant risk of carboplatin underdosing in cancer patients with normal renal function using estimated GFR: lessons from a stage I seminoma cohort. Ann Oncol 2014; 25: 1591–1597. 11. Shepherd ST, Gillen G, Morrison P et al. Performance of formulae based estimates of glomerular filtration rate for carboplatin dosing in stage 1 seminoma. Eur J Cancer 2014; 50: 944–952.

…estimates of glomerular filtration rate for carboplatin dosing in stage 1 seminoma. Eur J Cancer 2014; 50: 944–952. Annals of Oncology 25: 1458–1461, 2014 doi:10.1093/annonc/mdu218 Risks of the new EU Data protection regulation: an ESMO position paper endorsed by the European oncology community On 12 March 2014, the European Parliament voted on its pos- ition on the new European Union (EU) proposal for a General Data Protection Regulation, which will be now negotiated among the European Parliament, the Council of the European Union and the European Commission [1]. The final text will set the rules under which personal data are to be handled in the EU. It will thus affect many areas of our everyday life, including health and research.

…data are to be handled in the EU. It will thus affect many areas of our everyday life, including health and research. The cancer community is deeply concerned about unintended consequences of the current wording of the draft Regulation [2], which may put at stake the survival of retrospective clinical research, biobanking, and population- based cancer registries in the EU. In fact, the EU Parliament’s recent. Resolution [3] on the Regulation imposes, or may be interpreted as imposing, the requirement for researchers to ask for a patient’s ‘specific’ consent every single time new research is carried out on already available data and/or tissues. This would lead to the necessity of researchers continuously asking patients to ‘re-consent’ for every single use of their data. In fact, the European Parliament’s Resolution [3], Amendment 191 states that, 1b.

…for every single use of their data. In fact, the European Parliament’s Resolution [3], Amendment 191 states that, 1b. Where the data subject’s consent is required for the process- ing of medical data exclusively for public health purposes of scientific research, the consent may be given for one or more specific and similar researches. However, the data subject may withdraw the consent at any time. Likewise, it would hinder the very collection of vital health in- formation by requiring consent for the recording of data in population-based disease registries, which by definition need be all-inclusive, i.e. must collect all of the data of all individuals belonging to a given population. Amendment 191: 2.

…i.e. must collect all of the data of all individuals belonging to a given population. Amendment 191: 2. Processing of personal data concerning health which is neces- sary for historical, statistical or scientific research purposes shall be permitted only with the consent of the data subject, and shall be subject to the conditions and safeguards referred to in Article 83. 2a. Member States law may provide for exceptions to the require- ment of consent for research, as referred to in paragraph 2, with regard to research that serves a high public interest, if that re- search cannot possibly be carried out otherwise. The data in question shall be anonymised, or if that is not possible for the re- search purposes, pseudonymised under the highest technical standards, and all necessary measures shall be taken to prevent unwarranted re-identification of the data subjects.

…and all necessary measures shall be taken to prevent unwarranted re-identification of the data subjects. However, the data subject shall have the right to object at any time in accord- ance with Article 19. This text now forms the official position of the European Parliament. On behalf of the European oncology community, the entities endorsing this position paper would like the ongoing legislative negotiation process on the draft text to find the right balance to fully protect the privacy of patient data, © The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: [email protected]. editorials Annals of Oncology Ref. Ares(2020)2291345 - 29/04/2020 while maintaining ease of access to data for translational, clinical, and public health research.

- 29/04/2020 while maintaining ease of access to data for translational, clinical, and public health research. We would like to see a har- monised implementation of the Data Protection Regulation across 28 EU Member States in order to avoid varied interpreta- tions of the same law in different countries. We are convinced that a safe balance between all rights concerned can be achieved, and conflicts among different rights can be avoided, especially where we feel that such conflicts in reality may not exist at all. Progress in health research made over the last 40 years both on infectious diseases and non-communicable diseases, such as heart diseases and cancer, must continue in the EU countries. data protection and confidentiality Since the time of the Hippocratic Oath, the confidentiality of patient data has been protected. Additional safeguards exist through medical codes of ethics.

…the confidentiality of patient data has been protected. Additional safeguards exist through medical codes of ethics. In regard to research projects, their approval by independent review boards and/or ethics com- mittees is universally required. Patient representatives should be included in these committees as well as in those overseeing the storage of patient tissue in biobanks. Full transparency should be provided on the mechanisms of research and the functioning of biobanks, through online facilities for example, so that the public is kept updated on their evolution. We agree that every safeguard should be put in place to min- imise the risk of breaches in confidentiality, including resorting to forms of pseudo-anonymisation of data when this does not lead to compromises in data quality [3].

…resorting to forms of pseudo-anonymisation of data when this does not lead to compromises in data quality [3]. Data and tissues, such as tumour samples, are stored within hospital archives for medical and legal reasons, where breaches to confidentiality are generally negligible. Risks are further minimised when tissues are stored within biobanks, which place safety among their highest priorities. In any case, these safeguards can be properly foreseen by laws. When publishing the results of research studies, patient data are disseminated only as aggregate information and summary results. The identity of individuals remains completely undis- closed.

28 → 12

originalus šaltinis (PDF) ↗

Page 1 of 2 ESMO Feedback: Report on the General Data Protection Regulation (GDPR) The European Society for Medical Oncology (ESMO) is one of the leading professional organisations for medical oncology, with more than 35,000 members from over 172 countries. ESMO is committed to preventing new cancer cases, improving the quality of cancer care and promoting equal access to optimal treatments for all cancer patients. Throughout its advocacy and policy work on the General Data Protection Regulation (GDPR), ESMO has continuously stressed that in order for scientific research - including oncology research - to benefit from the Regulation, it needs to be interpreted and applied appropriately and in a harmonised manner across the entire EU.

…the Regulation, it needs to be interpreted and applied appropriately and in a harmonised manner across the entire EU. Clinical research, including observational retrospective clinical research, heavily relies on health data, and without access to such data this research would be negatively affected. Since the coming into application of the legislation, challenges have arisen with the implementation and interpretation of the GDPR across EU countries.

…of the legislation, challenges have arisen with the implementation and interpretation of the GDPR across EU countries. ESMO has called for a harmonious interpretation of the GDPR in all EU Member States, and has especially stressed the importance of the uniform application of the following provisions: • The inclusion of a withdrawable ‘one-time consent’ from patients allowing their data and tissues to be used, subject to strict ethical standards, for future retrospective clinical research, which will also ensure the viability of biobanking (recital 33); • The inclusion of a ‘no-consent’ principle to allow research based on data from population-based disease registries in line with strict ethical standards (recital 157). In addition, based on the day-to-day experience of medical oncologists with the GDPR, ESMO urges the European Commission to address in its report the following issues:

…of medical oncologists with the GDPR, ESMO urges the European Commission to address in its report the following issues: 1. Impact on daily work: • Increased difficulty to external consultations, communication between different units, electronic medical records from other healthcare regions using other EMR systems, which can impact the delivery of high-quality cancer care for patients. • Additional administrative burden and cost for all studies related to clinics and cancer biology. • Project delays and limitations of data collection - including ethnicity, origin, race, genetics, sexual orientation - which may have negative effects on the identification of health problems, including within minority groups. Ref. Ares(2024)891212 - 06/02/2024 Page 2 of 2

…the identification of health problems, including within minority groups. Ref. Ares(2024)891212 - 06/02/2024 Page 2 of 2 2. Impact on cancer research: • Significant difficulties in cross-centre data sharing (including pseudoanonymised data) and retrospective EMR-based studies. • Difficulties in cross-country EU collaboration - Ireland, Austria and Italy - often requiring explicit consent for retrospective translational research. • Major increase in administrative burden, impacting efficacy on research projects. 3. Impact on cancer registries: • Significant delays in the conducting of studies.

…efficacy on research projects. 3. Impact on cancer registries: • Significant delays in the conducting of studies. 4. Impact on cross-border cancer research projects in the European Union (EU), and involving third countries: • Cumbersome regulatory burdens and additional financial costs, often impacting participation in critical multi-national studies (e.g., on rare cancers) – especially when non-EU countries are involved.

…in critical multi-national studies (e.g., on rare cancers) – especially when non-EU countries are involved. 5. Proposed changes: • Simplify and harmonise the existing rules, as well as their interpretation, to facilitate research collaboration both within and between EU and non-EU countries, while respecting ethical principles. • Master and facilitate agreements for multiple cancer research projects by standardising procedures across countries based on good research practice and assessments of ethics committees, including for the use of anonymized aggregate genomic data to enable effective collaboration and implementation of projects. • Integrate clinical practice and research activities, especially in the area of consent for data use for research purposes and registries to ensure comprehensive and high-quality cancer care for patients. ESMO continues to monitor the implementation of…

originalus šaltinis (PDF) ↗