top of page

Survey: Sharing and accessing individual patient data from clinical trials

Trialists and researchers using trial data are invited to participate in a survey about individual patient data sharing, Shalini Dwivedi writes in this guest blog. Links to the surveys are at the end of this blog.


Transparency: promises and challenges

Clinical trial transparency enhances the quality of scientific research and innovation, reduces research waste, and strengthens public faith in clinical research and the pharmaceutical industry.


Over the last 15 years, regulatory authorities (US Food and Drug Administration, European Medicines Agency, and Health Canada) have taken steps to enhance clinical trial transparency, ranging from clinical trial registration to the publication of clinical trial documents.


Industry forums, such as Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) also welcomed these initiatives and recognised the commitment to share participant- and study-level data with researchers; provide public access to clinical study reports; share summary results with trial participants; create web-pages with data sharing policies and procedures; and publish results of all Phase III and trials of significant medical importance.


With the increasing amount of clinical trial data now being published, data privacy protection is incredibly important, and therefore clinical trial sponsors need to anonymise documents and data before their public release.

Survey: Awareness and impact


Although transparency and data-sharing initiatives bring significant value to trial participants, researchers, and healthcare providers, awareness of these initiatives and their real-world impact is yet to be explored.


To do this, Krystelis is conducting a prospective, survey-based, cross-sectional study through separate questionnaires for clinical trial researchers and investigators.


The questionnaires assess awareness and opinions about clinical trial transparency, responsibility towards the informed consent process, specifically the privacy protection of trial participants, and other related topics.


Links to surveys below


There are two different surveys, one for investigators who run trials themselves, and one for researchers who use individual patient data (IPD) from clinical trials.






TranspariMED looks forward to sharing the results of these surveys with its readers in May.



Note: Shalini Dwivedi is the Head of Medical Writing and Clinical Trial Transparency at Krystelis, a for-profit company. TranspariMED does not receive funding from Krystelis or any other industry source. We share the survey here because we think its findings will be interesting and relevant to the broader clinical trials community.



Recent Posts
bottom of page