In December 2018 the FDA released new guidelines for clinical trials of cancer drugs and biologics. Such endpoints serve different purposes at different points in time during the trial. During early trials the focus is on efficacy and safety. Later on, trials select endpoints for clinical benefits like improved survival and symptom relief. For cancer […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-04 10:48:432019-02-04 10:48:43New Breakthroughs Create New Cancer Research Endpoints
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.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-03 11:35:522019-02-03 11:35:52RWD and RWE for Medical Devices: Guidance for the use of Real-World Evidence
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 […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-02 11:35:462019-02-02 11:35:46Real World Data Part 4: How to Use it Properly
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 […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-01-31 11:35:342019-01-31 11:35:34Real World Data Part 3: Consider Relevancy
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.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-01-24 12:31:452019-01-24 12:31:45What to Know About the FDA’s Real World Evidence Framework
New Breakthroughs Create New Cancer Research Endpoints
in FDA GuidelinesIn December 2018 the FDA released new guidelines for clinical trials of cancer drugs and biologics. Such endpoints serve different purposes at different points in time during the trial. During early trials the focus is on efficacy and safety. Later on, trials select endpoints for clinical benefits like improved survival and symptom relief. For cancer […]
RWD and RWE for Medical Devices: Guidance for the use of Real-World Evidence
in Real World DataThe 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.
Real World Data Part 4: How to Use it Properly
in Real World DataIn 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 […]
Real World Data Part 3: Consider Relevancy
in Real World DataRelevance 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 […]
What to Know About the FDA’s Real World Evidence Framework
in Real World DataThis 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.