Pharmafile Logo

ISPOR hosts expert webinar exploring the value of ECAs for regulatory and HTA evidence needs

On Tuesday, October 7th, you are invited to join a Genesis Research Group-led webinar exploring the value of External Control Arm (ECA) studies. Gaining traction as part of evidence generation strategies in drug development, the true value of ECAs remains a topic of considerable discussion. As the industry grapples with the integration of real-world evidence (RWE) in drug development and commercialization, understanding when and how ECAs successfully contribute to regulatory, health technology assessment (HTA), and clinical decision-making has become increasingly important.

ECA webinar image

Speakers:

Alexandra Sosinksy, ScM, Senior Director, Genesis Research Group, Hoboken, NJ, USA

Frank-Ulrich Fricke, PhD, Dean, Technische Hochschule Nürnberg and Arbitration Board on Drug Prices, Nuremberg, Germany

Mira Pavlovic, MD, Director, Centre Sabouraud, Saint-Louis Hospital, Paris, France and Lisbon University, Lisbon, Portugal

Description

In this webinar, speakers offering diverse stakeholders’ perspectives will critically examine the value of ECAs by framing their investments (costs, data access, development timelines, and stakeholder engagement) versus the potential payoff (faster approvals, smaller or fewer randomized trials, stronger contextual evidence for single-arm trials, and enhanced confidence in the totality of the evidence). Speakers will share their wide-ranging experience with ECA design and evaluation as well as their forward-looking view on the role of ECAs in the mandatory European Union (EU) HTA Joint Clinical Assessment (JCA) of oncology and advanced therapy drugs.

Attendees will leave with a clearer understanding of the conditions under which ECAs are most likely to deliver return on investment (ROI) as part of a complete evidence package, including insights into HTA and regulatory variability and future opportunities like the evolving EU JCA landscape.

Learning Objectives

  • Articulate key considerations for investing in ECAs across regulatory and HTA environments including data quality, cost, and potential for expedited decision- making.
  • Examine variability in ECA acceptance and identify conditions in which ECAs meaningfully impact payer, regulatory and clinical decision-making.
  • Draw learnings from shared examples and experience to maximize ROI of ECAs, and anticipate how evolving policies, such as EU JCA, may affect future evidence planning.

 

RESERVE YOUR PLACE OR REGISTER TO RECEIVE THE RECORDING

This content was provided by Genesis Research Group

Company Details

 Latest Content from  Genesis Research Group 

Fit-for-purpose matchmaking webinar: a data selection and RWE approach for both regulatory and HTA audiences

This webinar reviews considerations for the design and data selection for RWE studies, including external control arm studies, to meet regulatory and HTA needs. Regulators and agencies responsible for market...

Genesis Research Group RWD / HTA / regulatory / ECA webinar on 15 Feb: reserve your place!

On 15 February 2024, Carole Longson and Allie Sosinsky of Genesis Research Group, a leading global provider of tech-enabled real-world evidence, market access, and HEOR solutions, will present a webinar...

Genesis Research Insights & Evidence webinar 20 Oct: Reserve your place!

Join Priti Jhingran of Genesis Research and Tijana Ignjatovic of Market Access Transformation (MAT) for their webinar 'Accelerating the Generation of Payer Insights and Evidence Across the Product Lifecycle to...

Leading pharmaceutical executive Jennifer Fillman joins evidence-based solution provider Genesis Research as Chief Financial Officer

International health economics and outcomes research (HEOR) and real-world evidence (RWE) organization Genesis Research has announced the appointment of Jennifer Fillman as its new Chief Financial Officer. Prior to joining...

Genesis Research and Syapse combine forces to offer RWE and data to oncology innovators

Genesis Research is delighted to announce a strategic partnership with Syapse®, combining the expertise and resources of both companies to better serve clients that are developing new oncology innovations.