The BIO International Conference presents the global biotech industry with many growth opportunities. From BIO programs and initiatives to BIO One-on-One Partnering and over 1,500 education sessions, it’s impossible to walk away without feeling like you have nourished your knowledge and understanding on any given topic. While you are there, please take the opportunity to hear from HealthCore’s head of research, Mark Cziraky, who will be digging in on the topic of Real World Evidence (RWE) in Therapeutics Development. He will provide insights into where we are in the evolution of evidence development and provide a few insights into the revolution that is to come.
This is a very timely discussion as the demand for evidence needed to power post-regulatory decisions has never been higher as payers, policy-makers and providers struggle to make the most effective decisions for individuals and populations being managed under real-world circumstances. Timely access to insights relevant to those populations is essential for the foundation of a sustainable high-quality, affordable healthcare system. While randomized controlled trials (RCTs) are designed to maximize the ability to determine if a product works and if a product is safe, they often leave real-world decision-makers at a loss when it comes to deciding if the product is the best choice for individuals or populations that are, more often than not, different than those included in the studies.
Real world research designs, such as pragmatic clinical trials (PCTs), are meant to supplement the findings from RCTs and help with the provision of more relevant and timely insight to payers and healthcare providers. PCTs in particular have the potential to greatly enrich and complement the findings from traditional RCTs. There is an increasing amount of interest from regulatory bodies of the promise of PCTs and other forms of RWE development in meeting regulatory requirements. Recent legislation such as 21st Century Cures is a good indicator that this interest will only continue to grow.
It has been our desire and mission since HealthCore’s inception to help accelerate the generation of evidence that is relevant to those making decisions in the post-approval world; evidence that empowers decision-makers to act with precision in their efforts to improve healthcare quality and affordability. It is awesome to see the growth in this space, especially over the last decade, and to see PCTs beginning to take center stage. It has been a long time coming.