Making Sense of the FDA’s Real World Data Program

in

Since the passage of the 21st Century Cures Act (aka Cures Act) in 2016, the FDA has been releasing new protocols and programs to expedite the approval process for new medical drugs and devices. One such new program is the Real-world Evidence (RWE) program that allows for the use of data collected outside of clinical trials to be incorporated into research submitted for FDA approval. In December 2018, the FDA published a framework for the RWE program in which they delineate the potential of RWE to support the approval of new indications for products already on the market, and post-approval study requirements.  Read more

RWD and RWE for Medical Devices: Guidance for the use of Real-World Evidence

in

The guidance of use Real World Data (RWD) and RWE for medical devices was released in August 2017 and was to provide clarifications of how and what RWD and RWE could be used in FDA regulatory process.  This guidance included the criteria for sufficient quality of RWD to generate RWE for medical device use. Read more

Real World Data Part 4: How to Use it Properly

in

In order to determine the suitability of Real World Data (RWD) for regulatory decision-making, the FDA will assess the relevance and reliability of the source and its specific elements. Important factors associated with RWD relevance primarily are: 1) sufficient details 2) capability to address specific questions 3) interpretable using informed clinical/scientific judgement. Reliability of RWD is associated with data accrual and data assurance. Data assurance consists of the quality of data element population, adherence, completeness, consistency and program evaluation process. Read more

Real World Data Part 3: Consider Relevancy

in

Relevance and reliability of RWD

In order to determine the suitability of Real World Data (RWD) for regulatory decision-making, the FDA will assess the relevance and reliability of the source and its specific elements. Important factors associated with RWD relevance primarily are: 1) sufficient details ; 2) capability to address specific questions; 3) interpretable using informed clinical/scientific judgement. Reliability of RWD is associated with data accrual and data assurance. Data assurance consists of the quality of data element population, adherence, completeness, consistency and the program evaluation process. Read more

What to Know About the FDA’s Real World Evidence Framework

in

This framework is for evaluating the potential use of Real World Evidence (RWE) to help support the approval of a new indication for drugs and biological products already approved or to help support or satisfy drug post-approval study requirements. This framework is also intended for application to biological products licensed. Read more

FDA Publishes Framework for Real-World Evidence Program

in

In December of 2018, the FDA published their Framework for FDA’s Real-World Evidence Program, which outlines the allowed usage of Real World Data (RWD) and Real World Evidence (RWE) in FDA submissions.

The sources of RWD and the application of RWE

The rationale for using Real-World Data (RWD) is to help support the approval of a new indication for a drug approved under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and to help support or satisfy post-approval study requirements. Read more