Strategy and Tactics to Assure Success in Clinical Trial Study Execution, Market Authorisation, and Market Access 

Discussion Points

Partnering with Patients for Clinical Study Success

This interactive workshop introduces participants to a 360° approach to obtaining patient insights and applying them for the successful design and execution of clinical studies. Through engaging activities, we address how to get to the heart of the patient’s decision-making process, assess their physical/emotional/social needs, and identify their motivators, barriers, and influencers as they relate to clinical study participation.

Participants learn how insights are analysed and applied in order to:

  • Design studies that appeal to the targeted patients
  • Determine effective and motivating recruitment methods
  • Engage and communicate with patients and caregivers
  • Identify retention methods that meet the needs of a specific patient population
  • Develop materials that resonate with patients and caregivers
Beyond Product Authorisation: Strategy and Clinical Trial Tactics to Meet Regulatory, HTA and Market Access Requirements

Session 1: Developing PROs to support labelling claims, especially for rare diseases/specialty products

Session 2: Use of surrogate endpoints in clinical trials – sufficient vs insufficient for approval?

Session 3: Reimbursement strategy and early HTA scientific advice – optimising your clinical development programme to support HTA access and reimbursement

This Patient-Centered Research Workshop was presented on November 15 2016, at Partnerships in Clinical Trials in Vienna. Mapi and industry experts including Kelly Franchetti, Valerie Powell, and Benoit Arnould shared their experience and expertise with attendees from across the industry. We would love to present this workshop for your team or at your tradeshow. To find out more, contact Mapi at

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At our Patient-Centered Research workshops, Mapi experts share their knowledge, insights, and experience on topics that are vital to a project’s success. As one of the leading voices in patient-centered research, Mapi is happy to share our expertise with the industry. 

At Mapi, we know that research centered on people is crucial to improving world health. Our unrivaled four decades of operational expertise in generating, synthesizing, and analyzing Real World Evidence and Health Economics Outcomes Research has established Mapi Group as the industry leader and recognized innovator of Outcomes Research methodologies and sciences.

Our research solutions bridge the distance between life science companies and patients, enabling market access and navigating the complex global regulatory environment.

Our commitment runs deep. Mapi Group is the only Health Research Company with a direct-funded non-profit organization dedicated to improving Patient Outcomes and Quality of Life. The Mapi Research Trust supports thousands of independent and academic research programs every year in over 130 countries, offering free and subsidized access to Clinical Outcomes Assessments (COA), their derivatives, and translations.