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Recommendations from the EGAN / ROCHE STRATEGY WORKSHOP

“Data sharing & Therapy development: Possibilities and Pitfalls”

Basel, 12-13 January, 2012

With the 8th joint Workshop, the Patients Network for Medical Research and Health (EGAN) and
Roche continue their constructive cooperation and once more provide a prime example on how patient
advocacy groups and industry can efficiently cooperate to promote health. The 2012 Workshop focused on issues and opportunities related to the sharing and handling of patient data in the context of research to better understand diseases and improve treatment and care for patients. The Workshop resulted in the following
recommendations for stakeholders and decision makers active in the area of promoting health. Recommendations on the collection and use of data in patient registries.

  1.  Patient registries1 should be used as a tool for research on improved treatments and enhanced quality of patient care.
  2. In order to make the data useful for research purposes, all patient registries should contain a minimum standardized content, “Core Mandatory Data”, that is collected an displayed in a standardized manner. This Core Mandatory Data could be complemented by phenotypic and genotypic data relevant to the respective diseases that are the subject of the register, with the additional data also collected in a harmonised forma .
  3. A set of standardized criteria that apply to patient registries across all disease areas, e.g. a common date format for collected data, should be worked out in cooperation between political stakeholders, regulators, patient organisations, academia and the industry, and take into account previous experience/best practice from these stakeholder groups.A database where information about patient characteristics is stored, such as diagnosis, family history, treatment- and care aspects.
  4. There should be a legitimate and justified process in place for ensuring that data collection and use is carried out in an ethical manner, protects the individual from discrimination and respects their rights to privacy and informed decision making on how one’s data are used. An appropriate and proportionate process for securing informed consent from patient volunteers must be in place.
  5. Patient organisations that host and take care of patient registries require sustainable support, e.g. funding or provision of fit-for-purpose data processing software. A long-term approach is essential to ensure that the data in the registry are suitable for research purposes, in particular to ensure that the data are kept up to date over time, that patients are regularly informed and consent to any changes of relevance for them and that the data remaincomparable.
  6.  As patient registry initiatives are often successfully initiated and led by dedicated individuals with a personal commitment, such individuals need to be identified and supported, in particular in countries facing a lack of resources for supporting the civil society.

Recommendations related to scientific possibilities enabled by data sharing

  1. Incidental findings (=useful research findings that were not actively sought) are an important issue for medical researchers. Recent progress – for example in sequencing techniques – means that incidental findings are almost inevitable where these techniques are employed. In order to maximize the value of these to the research community, and to protectthe interests of patients who may not wish to know of possible future disease risks, policies must be put in place for the handling and disclosure (or non-disclosure) of incidental findings prior to starting the data generation process. These must be clearly communicated to patient volunteers as part of the consent process. 
  2. Principles for how to deal with incidental findings must be discussed and standardized in a multi-stakeholder setting.
  3. There is a need to raise awareness amongst practicing clinicians of scientific developments in order to facilitate data collection.
  4. How to balance this educational need with the sheer amount of information is something that must be discussed between all stakeholders.
  5. There is an urgent need to manage public expectations on breakthroughs in genetic research, on the causes of diseases and how this may help patients.
  6. In cases where it may take time to translate a scientific breakthrough into an actual treatment, all stakeholders should report responsibly on genetic research progress, in order to not raise false hopes in patients suffering from a life-threatening disease.

Recommendations for regulatory framework on data protection in the EU

  1. The upcoming changes to the EU regulatory framework for data protection must not placedisproportionate administrative burdens on patient organisations and researchers whocreate patient registries that are essential tools for medical and epidemiological research in theinterest of improved treatment and care for patients. Likewise, penalties for offenses must be proportionate and reasonable.
  2. Any blanket exception for genetic information in upcoming legislation on data protection, “genetic exceptionalism”, is highly inappropriate. Genetic data should be safeguarded by adopting and implementing high standards of quality and confidentiality as with any other sensitive medical data.

These recommendations have been formulated by EGAN and Roche based on the Workshop
deliberations and discussions and are meant as a basis for further actions.

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