en-USen-GB
  • Princeton 1-3 May 2018
    Princeton 1-3 May 2018
  • Darmstadt, 15-18 May 2018
    Darmstadt, 15-18 May 2018
  • Tokyo 4-5 December 2017
    Tokyo 4-5 December 2017
  • Wellesely, MA 16-18 October 2017
    Wellesely, MA 16-18 October 2017
  • BERLIN 26-28 SEP 2017
    BERLIN 26-28 SEP 2017
  • REYKJAVIK 8-10 MAY 2017
    REYKJAVIK 8-10 MAY 2017
  • BLUE BELL, PA 24-26 OCT 2016
    BLUE BELL, PA 24-26 OCT 2016
  • BASEL 10-12 OCT 2016
    BASEL 10-12 OCT 2016
  • SINGAPORE 1-3 JUNE 2016
    SINGAPORE 1-3 JUNE 2016
  • UPPSALA 17-19 MAY 2016
    UPPSALA 17-19 MAY 2016
  • INDIANAPOLIS 25-27 APR 2016
    INDIANAPOLIS 25-27 APR 2016
  • NEW YORK 19-21 OCT 2015
    NEW YORK 19-21 OCT 2015
  • HORSHAM 5-7 OCT 2015
    HORSHAM 5-7 OCT 2015
  • SINGAPORE 3-4 SEP 2015
    SINGAPORE 3-4 SEP 2015
  • NORTH WALES, PA 18-20 MAY 2015
    NORTH WALES, PA 18-20 MAY 2015
  • SIENA 28-30 APR 2015
    SIENA 28-30 APR 2015
  • BANGALORE 5-6 FEB 2015
    BANGALORE 5-6 FEB 2015
  • CAMBRIDGE, MA 22-24 OCT 2014
    CAMBRIDGE, MA 22-24 OCT 2014
  • COPENHAGEN 16-18 SEP 2014
    COPENHAGEN 16-18 SEP 2014
  • SINGAPORE 20-21 MAY 2014
    SINGAPORE 20-21 MAY 2014
  • AMSTERDAM 14-16 MAY 2014
    AMSTERDAM 14-16 MAY 2014
  • BOULDER 30 APR - 2 MAY 2014
    BOULDER 30 APR - 2 MAY 2014
  • RESTON, VA 28-30 OCT 2013
    RESTON, VA 28-30 OCT 2013
  • DUBLIN 18-20 SEP 2013
    DUBLIN 18-20 SEP 2013
  • KASNSAS CITY 7-9 MAY 2013
    KASNSAS CITY 7-9 MAY 2013
  • EDINBURGH 22-24 APR 2013
    EDINBURGH 22-24 APR 2013
  • MONTVILLE, NJ 14-16 NOV 2012
    MONTVILLE, NJ 14-16 NOV 2012
  • MADRID 1-3 OCT 2012
    MADRID 1-3 OCT 2012
  • PARIS 21-23 MAY 2012
    PARIS 21-23 MAY 2012
  • EAST HANOVER, NJ 7-8 MAY 2012
    EAST HANOVER, NJ 7-8 MAY 2012
  • STRASBOURG 28-30 NOV 2011
    STRASBOURG 28-30 NOV 2011
  • NEWPORT BEACH 2-3 NOV 2011
    NEWPORT BEACH 2-3 NOV 2011
  • BANBURY 4-6 MAY 2011
    BANBURY 4-6 MAY 2011
  • CAMBRIDGE, MA 12-13 APRIL 2011
    CAMBRIDGE, MA 12-13 APRIL 2011
  • FORT LAUDERDALE 3-5 NOV 2010
    FORT LAUDERDALE 3-5 NOV 2010
  • BRUSSELS 6-8 OCT 2010
    BRUSSELS 6-8 OCT 2010
  • PARIS 5-7 MAY 2010
    PARIS 5-7 MAY 2010

WHO WE ARE

The eClinical Forum is a non-commercial think‐tank and a global consortium of organizations involved in clinical research. It provides a platform for member organizations to network and discuss ideas with industry peers in a non‐competitive environment.

News from the eCF

Login to also view news for Members.

Webinar: Conducting Clinical Research in an Age of Data Privacy

A thought-provoking topic -- slides available to eCF members

Webinar: Conducting Clinical Research in an Age of Data Privacy

Conducting Clinical Research in an Age of Data Privacy (presented by Susan Shelby, Biomedical Systems)

In the last few years, we've heard ever louder rumblings over data privacy concerns worldwide (and rightly so). Today’s digital world poses a privacy threat to citizens everywhere.  In the highly regulated world of clinical research, PHI breeches have been a threat long ago raised and addressed, with multiple attempts to mitigate threats to patient privacy in effect – we’re all familiar with HIPAA, Directive 95/46/EC, etc.

However, the revocation of Safe Harbor by the European Court of Justice in October 2015, and the subsequent adoption of the U.S.-E.U. Privacy Shield, resulted in a flurry of activity throughout the global clinical research community. In the wake of Safe Harbor, there came a worldwide rush to halt the collection and transfer of routine demographic data with particular data identifiers at clinical research organizations, core laboratories, data management groups.  Well-meaning global biopharmaceutical companies formed internal task forces to evaluate vendor compliance, often headed by legal team members or regulatory groups. Clinical vendors received stacks of requests to quickly find another means of compliance, in the vacuum that the fall of Safe Harbor caused, and prior to the Privacy Shield’s adoption. The Privacy Shield is the current umbrella sheltering the transfer of data from EU states to the U.S.  However, the EU has also passed the General Data Protection Regulation (GDPR) (Regulation (EU) 2016/679).  Effective in May of 2018, this regulation intends to strengthen and unify data protection for individuals within the European Union (EU), including the export of their personal data outside the EU. When the GDPR takes effect it will replace the data protection directive (officially Directive 95/46/EC), from 1995. It contains very strong provisions for the safety and consent of subject’s data, together with costly sanctions to enforce these provisions. 

Other questions can and should be raised about the restriction of certain data identifiers (DOB, gender, ethnicity) in clinical research. Might restricting the collection of some of these now restricted data compromise the clinical trial’s endpoints? If demographic data are entirely useless, why were they then ever collected in the first place?  The panicked pace at which these policies have been adopted threaten the thoughtful consideration of the impact to the clinical trial experiment itself. While clinical investigators must not restrict activities necessary to assure patient safety, enforcing too strict patient of privacy constraints may be at odds with scientific data integrity. The rush to halt the collection and transfer of routine demographic data will also in some cases limit the collection or transmission of clinically significant data, interrupting its use by those trained to interpret it.

What are companies doing in the current environment of the Privacy Shield?  How might the upcoming GDPR provisions affect clinical research? What are some approaches researchers and regulators may need to consider to gather data for drug approvals?  


Slides are available to members upon request. Please send a note to info@eclinicalforum.org

Print
Tags:
Rate this article:
No rating

Name:
Email:
Subject:
Message:
x

Not a member?
Visit the Membership page to learn 
How To Become a Member
(Join the eClinical Forum and learn how to leverage existing and emerging technologies for electronic clinical trials. Access an eClinical community, member-only knowledge, events and forums)

«February 2018»
MonTueWedThuFriSatSun
2930311234
567
2/7/2018 UTC
42

Webinar: Social Media in Clinical Trials: Going beyond Patient Recruitment

Presented by Les Jordan, Target Health

When most people think of social media in clinical trials, what comes to mind is using social media platforms for patient recruitment.  And while recruiting subjects through social media is a great use case, those platforms can be used for far more.  In this webinar we’ll discuss using social media across the clinical trial value chain along with a quick review of the various platforms in the marketplace.  Our discussion will include:

- Patient Recruitment 
- Patient Retention
- Building lasting patient communities 
- Safety monitoring

Webinar is for eClinical Forum members only. Please contact Suzanne.Bishop@eclinicalforum.org for registration.

Read more
891011
12131415161718
192021
2/21/2018 UTC
45

BoF Discussion: Archiving – who is responsible and how should we support them?

This webinar looks to set up a discussion of possible archiving alternatives and how practical they are.  Facilitated by Alan Yeomans, Pharmaceutical Consulting Group.  Participants are encouraged to share their ideas and experiences!!

This webinar is for eCF Members only. Please contact suzanne.bishop@eclinicalforum.org for additional information on registration to this event or membership.

Read more
22232425
2627281234
567891011

Upcoming events Events RSSiCalendar export