Continuing Education credits are not available for the archived offering.

This archived webinar is available for purchase through February 1, 2016.
Broadcast time: 1 hour 25 minutes

Series Overview

Providing greater access to clinical trial data has a number of benefits including facilitating further research to advance medical science and improve patient care. To deliver these benefits and respond to calls for greater transparency regulators, industry professionals, and academics have looked to create and frameworks for data sharing. These initiatives raise questions around appropriate mechanisms for improved openness and transparency, new data-use, privacy, and operational and infrastructure challenges.

DIA is presenting a three-part webinar series on Clinical Trial Transparency, which will begin with “Paving the Way for Greater Access to Data” a discussion focused on the benefits and concerns surrounding  greater access to clinical trial data such as how to facilitate further research and address concerns around privacy and legitimate re-use..  In our second installment, the focus will shift to “Connecting the Research Community: Data Sharing – Perspectives from Academia and Patient Advocacy Groups.” This discussion will place an emphasis on the opportunities and challenges to providing access to data from clinical trials conducted outside of industry. This will include the potential for developing a bridge between academia and industry frameworks for data access. Finally, this series will conclude with, “Understanding the Legislative Landscape: Regulatory Updates from the FDA and EMA,” taking a closer look at US and EU legislative requirements to include perspectives from the FDA and EMA on current and future initiatives.

Part 1 - Paving the Way for Greater Access to Data

Within the last 18 months we have seen the launch of a number of initiatives to realize the benefits of providing greater access to clinical trial data. Mechanisms have been introduced to facilitate further medical research and patient care, strengthen trust in clinical research through enhanced openness and maximize the contribution made by individuals taking part in trials. However with providing greater access, comes a series of legitimate questions around how to protect the privacy of individuals and manage concerns of data providers.

During this webinar, we will review which type of data is being made available, how the systems are working and safeguards to protect individuals and companies.  Further, we will discuss prospects for future development and the impact of industry wide commitments made by US and EU trade bodies (PhRMA & EFPIA) on providing greater access to clinical trial data.

Featured Topics

• Clinical Study Data Request
• EFPIA/PhRMA Principles

View Series Part 2 and Part 3

Part 2 - Connecting the Research Community: Data Sharing – Perspectives from Academia and Patient Advocacy

Part 3 - Understanding the Legislation Landscape:  Regulatory Updates from the FDA and EMA