The EU Clinical Trial Regulation mandates the publication of clinical research results, to be available to patients and the public in general. There is great enthusiasm about this, however there is also aspects such as confidentiality, intellectual property, liability, data protection, etc. which are not to be overlooked and which are currently causing many debates in the industry.This seminar brings together all stakeholders taking part in these discussions in a lively debate about the current status and future trends on this hot topic.
In addition to the speakers listed here, we also will have the testimony of a clinical trial participant, giving his opinion on Data Transparency.
15:45 – 16:00: Welcome
16:00 – 18:00: Seminar
Legal challenges related to transparency on clinical trial data (An Vijverman)
Today Many obligations exist (from different perspectives) with regard to transparency on clinical trial data.
The purpose of this presentation if to give an overview of all those different obligations, each time with their own background and to explain how they can all be reconciled with each other. Particular attention will be paid to the interaction between the data transparency requirements of the Clinical Trial Regulation and those of the data protection regulation. It will also be explained what exactly this data transparency means: which data must be made public; to whom/which organ must the data be made known; how must the transparency be organised and under which form must the data be made public, under which conditions?
Evaluation of Transparency initiatives (Sini Eskola)
Where are we now and where are we headed? Both European and US authorities are strengthening and extending requirements for public disclosure. This session shares an update on Industry’s commitment to data transparency, including what member sponsors have done to date with regards to “EFPIA – PhRMA principles of responsible clinical data sharing”, how their actions have been perceived and next steps. EFPIA is also preparing for Policy 0070 and Clnical Trial Regulation implementation. The presentation will highlight the main areas of both the policy and the Regulation and the key objectives and pain points for the industry in the implementation phase.
Industry experience in data disclosure (Tatjana Poplazarova)
Tatjana will present the practices developed and challenges encountered from the perspective of a company that has to operate globally, facing requirements from multiple regulatory agencies. Particular attention will be drawn to the upcoming requirement for sharing Lay Person Summaries brought up by the new Clinical Trial Regulation (Annex V).
Patient’s perspective on transparency of clinical data (Mitchell S)
In 2009 Mitchell was diagnosed with phase 2 Churg Strauss Syndrome. Having performed research on lung patients during his PhD, he had a good network of healthcare professionals in the field of pneumology. By adopting a very powerful attitude he was actively scanning for ongoing clinical trials, especially for one particular molecule that had shown promising results. After several mails he came in contact with a specialist in hyper eosinophilic disorders, and discovered that there was one trial ongoing. From a patient perspective, Mitchell is a heavy supporter of opening up patient data to accelerate research. By doing so he is convinced that innovative solutions will reach the patient sooner. Not only innovation in newly discovered drugs, but also in surrounding services to increase the quality of life of patients can emerge by opnening up data.