Starting with a mini-sentinel pilot program, the Sentinel initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the performance of FDA-regulated medical products. Working with public, academic, and private entities, the FDA developed the sentinel system and launched in 2016. The Sentinel System obtains information from existing electronic healthcare […]
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-18 09:00:452019-02-18 09:00:45What is the FDA’s Sentinel System (SS)?
Placebos are a staple of double-blind, randomized control studies. This is because they help to reduce study bias. When treating malignant hematologic and oncologic disease, however, there are ethical and practical problems that arise.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-18 08:00:272019-02-18 08:00:27Ethical and Practical Problems With Double-Blind Control Studies
Another emerging endpoint is minimal residual disease. This benchmark has emerged because even those in complete remission are known to experience relapses, which is true even when the patient has been in remission for significant periods of time. Emerging technology can now identify malignancies at levels orders of magnitude lower than what was previously conceivable.
Nonmetastatic, castration-resistant prostate cancer is a frequently recurrent form of prostate cancer. The treatment-resistant nature means continuous androgen-deprivation therapy and a resultant decrease in the quality of life of the patient. It also makes for a prolonged assessment period for treatments, which makes the overall survival rate an impractical endpoint. Thus, nonmetastatic, castration-resistant prostate cancer […]
Pediatric cancer is not simply adult cancer in a younger body. Thus, there are particular practical and ethical concerns when it comes to treating adolescents, as well as testing those treatments. In many cases, adolescents are not even eligible for such treatments.
/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svg00princeadmin/wp-content/uploads/2022/11/PrincetonPharmatech_logo.svgprinceadmin2019-02-04 12:47:552019-02-04 12:47:55Ethics and Practice in Experimental Childhood Treatment
What is the FDA’s Sentinel System (SS)?
in Statistical AnalysisStarting with a mini-sentinel pilot program, the Sentinel initiative began in 2008 as a multi-year effort to create a national electronic system for monitoring the performance of FDA-regulated medical products. Working with public, academic, and private entities, the FDA developed the sentinel system and launched in 2016. The Sentinel System obtains information from existing electronic healthcare […]
Ethical and Practical Problems With Double-Blind Control Studies
in FDA GuidelinesPlacebos are a staple of double-blind, randomized control studies. This is because they help to reduce study bias. When treating malignant hematologic and oncologic disease, however, there are ethical and practical problems that arise.
Emerging Endpoints: Minimal Residual Disease
in FDA GuidelinesAnother emerging endpoint is minimal residual disease. This benchmark has emerged because even those in complete remission are known to experience relapses, which is true even when the patient has been in remission for significant periods of time. Emerging technology can now identify malignancies at levels orders of magnitude lower than what was previously conceivable.
Emerging Endpoints: Metastasis-Free Survival
in FDA GuidelinesNonmetastatic, castration-resistant prostate cancer is a frequently recurrent form of prostate cancer. The treatment-resistant nature means continuous androgen-deprivation therapy and a resultant decrease in the quality of life of the patient. It also makes for a prolonged assessment period for treatments, which makes the overall survival rate an impractical endpoint. Thus, nonmetastatic, castration-resistant prostate cancer […]
Ethics and Practice in Experimental Childhood Treatment
in FDA GuidelinesPediatric cancer is not simply adult cancer in a younger body. Thus, there are particular practical and ethical concerns when it comes to treating adolescents, as well as testing those treatments. In many cases, adolescents are not even eligible for such treatments.