Preparing for Industry Shifts in Europe

NextLevel 2016

Preparing for Industry Shifts in Europe

Last week, medical affairs leaders gathered in London for NextLevel’s Medical Affairs Forum. At the congress, I was honored to chair the Best Practices in Late Phase Research track and meet with many industry leaders. Presenters shared their innovative views on integrating real-world evidence within product lifecycle strategies along with perspectives on study design and implementation challenges and opportunities.

Planning ahead to bridge real-world effectiveness and safety gaps with data collected in controlled trial settings was a recurring theme at the congress. This need will be accelerated by the impending changes within EU Clinical Trial Regulation, which will result in late-phase planning becoming more important during the pre-license phase. Pharmaceutical sponsors must consider how these regulatory changes will affect the types of studies needed and how to mitigate difficulties brought about by the proposed classification of low-interventional trials.

Another theme touched on the increasing availability of data through EHR systems, commercial claims databases, registries, and other sources of secondary data, and the opportunities this data offers in terms of new patient recruitment strategies and the design of retrospective and prospective hybrid solutions. Hybrid designs offer opportunities for the collection of tailored real-world data that encompass outcomes from different stakeholder perspectives and allow leveraging a single study framework.

Finally, the use of new technologies was discussed. Sophisticated, user-friendly electronic data capture (EDC) systems were highlighted as a means for efficient data entry and management for observational studies and for improving the patient’s ability to complete surveys via tablets and mobile devices.

With shifts in regulations, data sources, and technologies, it is more important than ever to establish a clear roadmap that will generate the right evidence. UBC offers a full spectrum of clinical development and late stage research solutions to help you prepare for any evidence hurdles you might face. If you’d like to discuss any of our solutions for generating real-world evidence, contact us now.