In contrast to clinical development, in which the randomized controlled trial (RCT) is the go-to study design, real-world research encompasses a broader array of designs from which to choose. There are retrospective approaches, including database analysis and manual chart review, as well as prospective approaches, such as observational cohort studies (or registries), pragmatic clinical trials, and expanded access programs. Not surprisingly, these approaches have their relative strengths and limitations as well as time and resource requirements, making choice of one design over another a challenge. It is no wonder that confusion abounds among study sponsors.
But the growing importance of real-world research and the real-world evidence (RWE) it generates cannot be ignored. In the United States, the 21st Century Cures Act requires that FDA provide a framework and guidance on the use of RWE in regulatory decision making, driving up interest on the part of life sciences companies to heretofore unseen levels.
The real-world research team at Syneos Health routinely offers its customers consultative services to assist them with these difficult study design decisions. As part of the team’s thought leadership efforts, an algorithm has been developed and tested to assist customers in the high-level aspects of choosing the most appropriate study design, based on responses to a structured set of eight simple questions.
Read the whitepaper titled “Which Real-World Research Design Is Best?: An Algorithmic Approach to Optimal Study Design for Outcomes Research” here.
Should you have any questions about the whitepaper or Syneos Health’s approach to RWE, please contact David Thompson, PhD, Senior Vice President, Real World Evidence and Late Phase at firstname.lastname@example.org.