Why YOU should attend

A Q&A with programme committee member Robert A. Paarlberg, Principal, Paarlberg & Associates LLC, USA

We sat down with Robert A. Paarlberg, Principal, Paarlberg & Associates LLC, USA, to get his thoughts on the meeting:

DIA: Why should clinical trial professionals attend this event?

Robert A. Paarlberg: The DIA Global Clinical Trials Conference offers professionals working in the clinical trial disclosure and transparency space a unique platform to learn about the latest developments and changes through regulators’ first-hand perspectives, including representatives of EMA, Health Canada, ClinicalTrials.gov/NiH as well as from industry experts and patient advocates. Moreover, attendees will gain insights on how to meet the new challenges in the EU, US and other countries from best practices and case studies of industry’s key challenges. The DIA Global Clinical Trials Conference connects you with experts and professionals throughout Europe and the US.

DIA: The pre-conference workshops are an addition to the conference. What is unique about both workshops, “The Evolving Disclosure/Transparency Landscape” and “Operationalizing Policy 0070”?

Robert A. Paarlberg:  “The Evolving Disclosure/Transparency Landscape” workshop is specifically designed for individuals who are new to this space and aims to provide a well-rounded background on how the disclosure and transparency requirements have evolved from 2004 – 2018. The “Operationalizing Policy 0070” workshop will provide insights on how companies with extensive experience with this policy are addressing challenges. Sessions will also focus on the interface with the General Data Protection Regulation (GDPR), what other “Policy 0070 like” regulations exist in other regions, and how these submissions will be impacted by the EMA prioritisation shift.

DIA: The European Medicines Agency (EMA) recently became the first medicines regulatory authority worldwide to give open access to clinical data through its flagship Policy 0070. What reactions have you already observed from companies?

Robert A. Paarlberg: Company sponsors who have submitted Policy 0070 packages to EMA have found this process to be a very resource intensive undertaking. It involves internal and, in some cases, external resources, depending whether companies outsource some of their operations, such as redactions and anonymizations. EMA has put a hold on Policy 0070 submissions effective August 1, 2018. One of the main challenges for companies is not knowing when EMA will reinitiate Policy 0070 submissions, as well as not knowing when Health Canada’s clinical data policy Initiative will become effective. These circumstances have made it difficult for companies to plan ahead.