PSDM DATA SHARING EVENT

December 1 , 2016
Hosted by Abbott, Weesp, the Netherlands

Since the introduction of the EMA policy on publication of clinical data in October 20141, data sharing is an on-going hot topic in clinical development.

Next to sharing of clinical reports it also concerns the publication of Individual Patient Data (IPD) in the future. Obviously this will help physicians and patients making better decisions and is in the advantage of researchers too.

And what does this mean for sponsors, participants in the trials and for us in the field of clinical data sciences? That’s what the DATA SHARING event on Thursday December 1st is about.

Because, what is clinical data? ADaM data or also all raw data? Meta-data included, SAS code as well?

Are we allowed to share the data to others?! Is it legal and should we adjust the patient inform consent?

To protect patient privacy, precautions need to be taken when sharing Individual Patient Data (IPD), i.e. data have to be de-identified. For example, exact ages above 90 are not allowed to be shared, other than “> 90”.

Do you know that pharmaceutical companies already installed a website, the Clinical Study Data Request Site, to share their data? And companies are preparing themselves for data sharing?

Are you aware that a lot of medical journals have statements on data sharing in their policy as well?

1 http://www.ema.europa.eu/ema/?curl=pages/special_topics/general/general_content_000555.jsp

The PSDM organized a local event with representatives who highlighted important aspects of the dynamic topic and presented two case studies of DATA SHARING.
This DATA SHARING event started with lunch.

Agenda

12.00 Lunch
12.45 Welcome Stefan Driessen
12.45 PSDM annual meeting
 Egbert Biesheuvel
13.10 Introduction of the topic Egbert Biesheuvel (Nutricia)
13.35 Discussion of current status Uli Burger (Roche)
14.00 Scientific Health Research: legal and other issues Marie-José Bonthuis (University Medical Center Groningen)
14.25 Clinical Study Data Request Site (incl.demo) Thijs van den Hoven (Astellas)
14.50 Coffee-break
Data sharing – case studies
15.20 – Astellas Ad Theeuwes
15.45 – Nutricia Egbert Biesheuvel
16.10 Panel discussion All, led by Stefan Driessen
16.40 Closing