Key Considerations in Planning RWE Studies

05 October 2023
Katerina Krinitsyna, Head of Business Development
Key Considerations in Planning RWE Studies

An effective evidence strategy and efficient use of high volumes of real-world information play an increasing role in achieving market access and therefore healthcare decision-making. Appropriate project management defines how your study may benefit a company's efficiency and strategic plan as a whole. Discover how thinking in terms of strategic project management can strengthen your launch, save you money, and improve your patient outcomes. 


Plan and Schedule  

Let's start with the basics: time is of the essence. Early and comprehensive planning provides the opportunity to think about regulatory pathways and to address key gaps in therapy understanding. A carefully planned schedule enables realistic timelines and prevents future hurdles and working to tight deadlines. What’s more, a precise timeline for every stage of the project life cycle reflects well on your company reputation and your team productivity.  


Identify Evidence Needs 

Identify evidence needs that must be addressed to satisfy your sponsors, regulators, and patients. Your project framework has to be structured and focused on specific research questions. Discuss and prioritize the initial overall goals identified with your dedicated team. Understanding these goals, as well as the perspectives of stakeholders, is crucial for ensuring that the right evidence is generated. At [company name] we assemble a roadmap that clearly outlines study goals, and this is shared with all those involved to increase their awareness and allow them to properly plan all stages of the journey. 


Review Current Evidence  

Identify and access appropriate types of RWD sources for RWE and review the advantages of each option. Can existing data be analyzed? Are the answers to be found across literature reviews or RCT data? If so, comprehensively research all current and accessible evidence in the field. A thorough review will help you to determine which existing evidence could help answer your project questions. Establish a plan that covers the data collection methodologies to be used and outlines tangible next steps.  


Generate New Evidence Insights 

Explore all the resources that are available to you today, and don't rush to “jump into the deep end". Identify and access the most relevant and valid types of RWD sources for generating RWE and review the advantages of each option. Carefully examine your internal and external resources, and check whether you have partners that can provide access to additional related data. Appropriate resource allocation has to fill the gaps in the available evidence and generate new RWE insights in order to satisfy all strategic objectives. Don't forget to link the evidence generation plan with primary and secondary research questions, clinical endpoints and study subject inclusion and exclusion criteria. 


Interpret Outcomes 

Detailed and thorough interpretation of outcomes from various data sources and metrics is an essential step. Once data is gathered, you can publish your study value proposition to all target audiences and stakeholders. 



Get in touch with the Therapyte team to discover how we can develop a well-crafted clinical development plan and build a strong evidence strategy for your projects.