I was just sent this in my email. Knowing nothing about it, and unable to comment, it’s here in my Rejected Posts alternative blog. I’m keen to hear what others, familiar with it, think of this 21st Century Cures Act. (It reminds me of the Doors, 20th Century Fox). Actually, I think this was passed in 2016, so it’s not big news. Of course the push for “personalized medicine is part of this, never mind that it hasn’t had much success yet. I would have thought observational studies were at least admissible before. Do they require adjustments for data-dredging? Or not? I’m glad they will mention “pitfalls”. Now I’m going to have to ask my doctor which type of study a drug has had its approval based upon.
Thanks to the 21st Century Cures Act you are no longer bound to traditional clinical trials to prove safety and efficacy — new and exciting alternatives are available to you!
Observational studies are now acceptable in the FDA’s approval process. These studies allow the collection of real-world usage information from patients and physicians. And they allow for the harvesting of data from existing studies — from university research to patient data registries — to use as evidence of a product’s efficacy and safety (my emphasis).
Observational research requires an entirely different set of procedures and careful planning to ensure the real-world evidence collected is valid and reliable.
The 21st Century Take on Observational Studies walks you through everything you need to know about the opportunities and pitfalls observational studies can offer. The report looks at the growing trend toward observational research and how provisions in the 21st Century Cures Act create even more incentives to rely on real-world evidence in the development of medical products. The report covers:
- Provisions of the 21st Century Cures Act related to observational studies and gathering of real-world evidence
- The evolution of patient-focused research
- How observational studies can be used in the preapproval and postmarket stages
- The potential for saving time and money
- New data sources that make observational studies a viable alternative to clinical trials
- How drug- and devicemakers view observational research and how they are using it
Order your copy of The 21st Century Take on Observational Studies: Using Real-World Evidence in the New Millennium and learn effective uses of observational studies in both the preapproval and postmarket phases; how to identify stakeholders and determine what kind of data they needed, and how the FDA’s view on observational research is evolving.