Swiss Real-World Data Study for Patients Undergoing Weight Management Treatment

This privacy policy will explain how Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH uses the personal data collected from you when you use the services at this clinic.

As well as using medical data to provide medical care, Adimed are contributing non-identifiable patient data for use in a single medical research study. The Zurich Kanton ethics committee (Zurich Kantonale Ethikkommission) has provided approval for this study to be conducted. The study is sponsored by Novo Nordisk (data controller) and the study analysis will be conducted by IQVIA (data controller and data processor). Novo Nordisk will not receive access to individual patient-level data. Only aggregated results will be presented to Novo Nordisk or otherwise published.

What information do we collect?

Adimed provides non-identifiable details about patients using their services for use in medical research studies. These include:

  • Clinical information such as procedures, operations and previous use of weight management medications and treatments
  • Additional key information about the patient such as year of birth, gender, weight-related laboratory values and weight-related measurements such as BMI

Adimed does NOT include any direct patient identifiable information such as names, addresses, insurance numbers, or full dates of birth in any of the data used for research studies and no identifiable information will be passed on to IQVIA or Novo Nordisk. 

The purpose for which data is processed and used

This data may be processed and used for the purpose of supporting medical research, specifically focusing on the clinical outcomes of patients who undergo weight management treatment and the effectiveness of such treatments.

Adimed is partnering with IQVIA, a company specialising in health information technologies and clinical research worldwide. IQVIA provide products and services including medical research and analytical solutions to healthcare and life sciences organisations.

The study is sponsored by Novo Nordisk, a pharmaceutical company specialising in diabetes and weight management care who are commissioning the study and are thus joint controllers of the de-identified data with IQVIA.

IQVIA are a joint study data controller due to their role in developing the study protocol. IQVIA are also a data processor with respect to the study as they will processes the data on the basis of legitimate interests in supporting medical research. Technical and organisation safeguards measures are in place to ensure the appropriate handling of the de-identified study data.

Who is the data made available to?

IQVIA carries out research on behalf of or makes data available to, the following research groups only:

  • Providers / commissioners of healthcare services: healthcare providers, private secondary care providers, Public Health bodies, and regulatory bodies
  • Academics / universities
  • Life science industries: pharmaceutical companies, medical device companies, industry bodies
  • Other: patient groups and healthcare related charities

Data will be used for medical research uses only and will not be used for commercial purposes such as conducting analysis for insurance companies, sales and marketing or for understanding sales force performance.

Study Protocol Review

All studies are required to show scientific merit, fulfil the research purpose outlined, and demonstrate potential benefit to health and social care.

All study protocols MUST be approved by a recognised scientific review board. Any research will be submitted to the responsible Swiss Cantonal ethics committee which assesses research requests from all areas of human research. This includes clinical trials, other research projects with people, research on the deceased, embryos and foetuses, and research projects with biological material and health-related personal data. Projects for research into diseases or for the structure and functioning of the human body require approval from the responsible cantonal ethics committee before they can be carried out.

This study has received formal approval from Kantonale Ethikkommission Zurich (ID 2019-02363)

Data Retention

IQVIA holds non-identifiable patient data for patients using Adimed services from 1 October 2016 to 31 December 2019 to support studies investigating the real-world effectiveness of Saxenda treatment on patients using the therapy for weight management.

IQVIA retains data in accordance with UK Medical Research Council (MRC) guidelines which recommend basic research data and related material be retained for a minimum of 10 years after the study has been completed. This is to support good research practice which requires research studies to be reproducible. More information can be found here: (https://mrc.ukri.org/documents/pdf/retention-framework-for-research-data-and-records/).

Security

IQVIA has implemented an Information Security Management System. IQVIA implements technical and organisational security measures to ensure a level of security appropriate to the risk and to prevent accidental or unlawful destruction, loss, alteration, unauthorised access to or disclosure of the data.

IQVIA stores de-identified patient data on secure servers located in the UK. Access to the data is strictly controlled and limited internally to authorised personnel. External use and access is governed by Data Sharing Agreements which are legally binding agreements detailing confidentiality and the terms on which the data is shared, used, stored and accessed.

Consent and patient rights

Data is collected in line with the requirements under applicable data protection law. Patients are informed by means of posters in the clinic that their data is collected for scientific research and they can withdraw their consent at any time by notifying the practice. Patients have the right to request the erasure of their data from the IQVIA held dataset.

Patients have the right to request rectification of their personal data, or restriction of processing of personal data concerning the data subject, or to object to the processing of such personal data, as well as the right to data portability.

Changes to this Notice

We may update this notice from time to time. We encourage you to review this notice periodically to stay informed about how we are using and protecting data. Any changes to this notice take effect immediately after being posted or otherwise provided by us.

Contact details

Questions and comments regarding this notice should be addressed to Sam Hemphill at IQVIA, 210 Pentonville Road, London, N1 9JY or to eu.dpo@iqvia.com

About Us

IQVIA Limited (“IQVIA/we/us/our”) are part of the IQVIA Inc. group of companies serving the combined industries of health information technologies and clinical research worldwide. We specialise in the provision of products and services including medical research and analytical solutions to healthcare and life sciences organisations. In the UK, IQVIA has collected and supported the research use of non-identified patient data for over 20 years.

For the purpose of this privacy notice and pursuant to data protection legislation, IQVIA is the data controller of the non-identifiable patient data used for the purposes of the study ‘understanding Saxenda real-world clinical effectiveness in Switzerland’.

We are registered in England and Wales as: IQVIA Ltd, registration number: 03022416 (“IQVIA”) and our registered office is 3 Forbury Place, 23 Forbury Road, Reading, United Kingdom, RG1 3JH.