Arena International is happy to announce the Fifth Edition of the Clinical Trials Yearbook is now live! Looking back on 2017, there were a number of significant developments that continue to affect how clinical trials are conducted. The first CAR-T therapy was approved, a major breakthrough in the fight against cancer. The final guidance on lay summaries was released, paving the way for greater transparency in studies run across Europe. And the ICH GCP E6 (R2) addendum came into effect, introducing tighter rules on data management.
Each development is symbolic of how the industry is changing with the times. As sponsors and vendors continue to adapt, 2018 looms ever larger, bringing with it even greater challenges. As such, the Clinical Trials Yearbook 2018 seeks to be your definitive guide in these testing times.
The Fifth Edition, unlike previous years, will provide both a retrospective take on 2017 while looking forward to the challenges that await in 2018 and beyond. To follow suit, the Yearbook has been condensed into two sections: the 2017 Lookback and the 2018 Outlook.
As always, the Yearbook has drawn on insights from the brightest minds the industry has to offer. In the 2017 Lookback, Nigel Hughes (Janssen R&D) assesses the growing role of real world data in clinical trials. Meanwhile, Brandon Early provides operational considerations for basket and umbrella trials. And Revati Tatake (GlobalData) delivers an in depth report on the biosimilar landscape.
The 2018 Outlook shines a spotlight on the key challenges to consider for 2018. John Shillingford (Orsus Medical) ponders what the post-Brexit era will look like for the U.K. life sciences industry, and how they should prepare for it. The General Data Protection Regulation (GDPR), coming into effect in May 2018, is on the minds of many within industry. Jess Sohol (UBC) sits down with me to discuss what your organization needs to do to be GDPR compliant.
So as you sit down to read this edition, we hope that by learning from the challenges of the year before, you can prepare for the year ahead. To access your free copy, click here! Enjoy!