Writing a DMP when doing valuable research with highly sensitive patient data

What does research data management mean in the daily practice of a researcher? In this series of interviews by RDM Support, researchers share their experiences on various aspects of research data management. In this interview, Elise Quik talks about her experience with our data manager service at the HTx project.

Postdoc researcher Elise Quik works at the Faculty of Science on the HTx project. In this Horizon 2020 project, international research is conducted into complex combinations of therapies for four different diseases: head and neck cancer, diabetes, multiple sclerosis (MS) and myelodysplastic syndrome (MDS), a blood disease that can result in leukaemia. For this purpose, the researchers involved in the project use so-called real world data, such as data from patient files. This is very privacy-sensitive data. How do you deal with it responsibly? For this they have called in the help of Lena Karvovskaya, data manager at RDM Support.

By using data from patient records, we can investigate the effectiveness of complex treatment methods

Elise Quik, Photos by Annemiek van der Kuil | PhotoA.nl

HTx project

Elise Quik says: "Treatments are more and more patient-oriented. It is no longer the case that a patient is diagnosed with a certain disease, and receives the standard treatment. What we see is that, for example, MS patients have different disease profiles and react differently to treatment. Until now, research into the effectiveness of medicines has mainly been conducted using randomised controlled trials (RCTs). Here, one drug is administered to one patient group, and the results of this group are compared with a similar patient group receiving a placebo or a single comparative treatment. In this type of research, the disease characteristics of the individual patient are only partially taken into account and this type of research is often limited to a single drug or medical device.

Our research is different in that we use data from patient files as well as RCTs. This allows us to investigate the effectiveness of combinations of treatments, and in our analyses we take the disease characteristics into account. This will support personalised treatment advice that will be suitable to be shared with patients and their physicians across Europe. HTx also aims to increase patient-centricity in decision-making, as well as the development of flexible reimbursement models for complex health technologies.”

Data management plan

Writing a data management plan (DMP) before starting a research project is mandatory at Utrecht University. But it is also a requirement for Horizon 2020 funded projects.  Elise explains: "Especially for the sensitive data we use, it is wise to think about responsibilities and regulations. In a DMP you describe how you deal with all research data during and after the research. Lena helped us with the writing of this DMP and especially with the interpretation of the General Data Protection Regulation (GDPR). The DMP answers several questions, such as:

  • What data is collected or used?

  • Who is responsible for this data?
  • Is it possible to share this data? If so, in what way?
  • How is the consent of the patients arranged?
  • The research funder also asks for the research results to be made as public as possible. How do we do this?"

I would advise anyone who writes a research proposal to reserve some financial resources for hiring a data manager

"I wrote the data management plan with Lena. I know a lot about the content of the project and Lena knows a lot about data management and the GDPR. I would advise everyone who writes a research proposal to reserve some financial resources for hiring a data manager. Not all researchers have the extensive knowledge of a data manager. In addition, the rules change regularly, and you want to be sure that you are up-to-date. A data manager also thinks far ahead. How will you make your data available at the end of the project? These are the questions you will quickly skip as a researcher, and which you will still be struggling with at the end of the project. A data manager ensures that you spend less time on these questions."

Elise Quik

Elise Quik started out with Psychology at Utrecht University. She has always been interested in health care. During her studies she researched the use of the drug Ritalin by ADHD patients. This is how her interest in pharmacy has been aroused. After having worked as a postdoc at the UMCG, the University of Groningen and UMCU Julius Centre for several years, she is now back at the place where her scientific career began, at Utrecht University.

Research Data Management Support

Do you also handle privacy sensitive data in your research? In that case, be aware that a DMP is but one of the steps you must take to comply with European regulations. In addition to a DMP, you may also need to fulfill other procedures and/or documentation. Take a look at our Guide Handling personal data or follow our workshop Handling personal data in research to learn more. Of course we are also there for you for personal advice. Email us at info.rdm@uu.nl.