The National Center for Health Research (formerly known as the National Research Center for Women & Families) is a Washington, D.C.-based non-profit organization founded in 1999, providing health-related services such as providing free information and training based on research findings; educating policy makers and working with the media.[1] The President of the organisation is Diana Zuckerman. The primary program is The Cancer Prevention and Treatment Fund, which utilises an online health hotline.
In February 2011, Center staff published a study in Archives of Internal Medicine, which evaluated the Food and Drug Administration (FDA)’s recalls of devices that the agency considered potentially deadly or otherwise very high risk.[2] Using FDA data, the authors determined that most of the devices that were high-risk recalls had never been studied in clinical trials prior to FDA approval, and that the FDA needed to use more stringent criteria for implanted medical devices and those used to diagnose serious illnesses, and an editorial in the same issue agreed.[3] The study resulted in a hearing in the U.S. House of Representatives four days later and major U.S. newspapers and network news programs, where device industry representatives argued that clinical trials were not needed and the cost of doing the studies would interfere with job growth and innovation.[4]
In 2014, the organisation published a study in the JAMA Internal Medicine journal about the scientific evidence submitted to the FDA to support the marketing of implanted medical devices under the agency’s 510(k) review process. The study concluded that most of the implanted devices were not required to submit data from clinical trials or scientific evidence of safety or effectiveness before they could be sold.[citation needed]
In 2016, a study was published in the same journal about recently approved cancer drugs that had been criticized by other researchers as having no evidence that they decreased mortality or helped patients live longer. The Center’s follow-up study found no new evidence that any of the drugs affected survival, and only one of the drugs had clear evidence of improving patients’ quality of life. The study also found that the cost of the drugs ranged from $20,000 to $180,000 despite the lack of scientific evidence of benefit.[citation needed]
In 2017, staff published a paper in Milbank Quarterly criticizing the FDA for its failure to safeguard electronic health records and other device software from hacking and other cybersecurity threats. They stated “current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market”.[6] They added that legislative changes resulting from the law entitled the 21st Century Cures Act “will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients.”
The center published another study in Milbank Quarterly in 2018 called “Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?”.[7] The study investigated whether new, high-risk medical devices had been proven safe and effective for women, minorities, or patients over 65 years of age. Despite a law encouraging diversity in clinical trials submitted to the FDA, the results indicated that most studies did not conduct subgroup analysis on all these major demographic groups, thus providing no information about safety or effectiveness for most patients.[citation needed]
Awardsedit
Two awards are given by the center each year:
The Foremother Lifetime Achievement Award "recognizes women who expanded women’s horizons, improved our communities, and made remarkable contributions to our country".[8]
The Health Policy Heroes Award "honors men and women (and sometimes boys and girls) who have changed the public debate and public policies in ways that help to improve the lives of adults and children nationwide".[8]
Publicationsedit
Fox-Rawlings, Stephanie R.; Gottschalk, Laura B.; Doamekpor, Laurén A.; Zuckerman, Diana M. (September 2018). "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?". The Milbank Quarterly. 96 (3): 499–529. doi:10.1111/1468-0009.12344. PMC6131322. PMID 30203600.
Ronquillo, Jay G.; Zuckerman, Diana M. (September 2017). "Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health". The Milbank Quarterly. 95 (3): 535–553. doi:10.1111/1468-0009.12278. PMC5594275. PMID 28895231.
Zuckerman, Diana; Doamekpor, Laurén Abla (June 2015). "More data are needed for Essure hysteroscopic sterilization device". Contraception. 91 (6): 520. doi:10.1016/j.contraception.2015.02.027. PMID 25779602.
Gonsalves, G.; Zuckerman, D. (25 March 2015). "Commentary: Will 20th century patient safeguards be reversed in the 21st century?". BMJ. 350 (mar25 7): h1500. doi:10.1136/bmj.h1500. PMID 25814537. S2CID 19510018.
Zuckerman, Diana; Brown, Paul; Das, Aditi (1 November 2014). "Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices". JAMA Internal Medicine. 174 (11): 1781–7. doi:10.1001/jamainternmed.2014.4193. PMID 25265047.
Zuckerman, Diana M.; Brown, Paul; Nissen, Steven E. (13 June 2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID 21321283.
Referencesedit
^"Home Page". National Center for Health Research. Retrieved 2022-09-08.
^Zuckerman, Diana M.; Brown, Paul; Nissen, Steven E. (13 June 2011). "Medical Device Recalls and the FDA Approval Process". Archives of Internal Medicine. 171 (11): 1006–11. doi:10.1001/archinternmed.2011.30. PMID 21321283.
^Redberg, Rita F.; Dhruva, Sanket S. (13 June 2011). "Medical Device Recalls: Get It Right the First Time". Archives of Internal Medicine. 171 (11): 1011–2. doi:10.1001/archinternmed.2011.27. PMID 21321286.
^"News Analysis: Interviews, Op-eds, & Editorials - National Center For Health Research". National Center for Health Research. Retrieved 8 August 2015.
^"Home - United States Senate Special Committee on Aging". United States Senate. Retrieved 8 August 2015.
^Ronquillo, Jay G.; Zuckerman, Diana M. (September 2017). "Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health". The Milbank Quarterly. 95 (3): 535–553. doi:10.1111/1468-0009.12278. PMC5594275. PMID 28895231.
^Fox-Rawlings, Stephanie R.; Gottschalk, Laura B.; Doamekpor, Laurén A.; Zuckerman, Diana M. (September 2018). "Diversity in Medical Device Clinical Trials: Do We Know What Works for Which Patients?". The Milbank Quarterly. 96 (3): 499–529. doi:10.1111/1468-0009.12344. PMC6131322. PMID 30203600.
^ ab"Foremother and Health Policy Hero Awards Luncheon". National Center for Health Research. 7 May 2018. Retrieved 17 September 2019.
External linksedit
Official website
February 16, 2024
national, center, health, research, this, article, multiple, issues, please, help, improve, discuss, these, issues, talk, page, learn, when, remove, these, template, messages, this, article, contains, wording, that, promotes, subject, subjective, manner, witho. This article has multiple issues Please help improve it or discuss these issues on the talk page Learn how and when to remove these template messages This article contains wording that promotes the subject in a subjective manner without imparting real information Please remove or replace such wording and instead of making proclamations about a subject s importance use facts and attribution to demonstrate that importance August 2022 Learn how and when to remove this template message This article needs additional citations for verification Please help improve this article by adding citations to reliable sources Unsourced material may be challenged and removed Find sources National Center for Health Research news newspapers books scholar JSTOR August 2022 Learn how and when to remove this template message Learn how and when to remove this template message The National Center for Health Research formerly known as the National Research Center for Women amp Families is a Washington D C based non profit organization founded in 1999 providing health related services such as providing free information and training based on research findings educating policy makers and working with the media 1 The President of the organisation is Diana Zuckerman The primary program is The Cancer Prevention and Treatment Fund which utilises an online health hotline National Center for Health ResearchFounded1999FounderDiana ZuckermanTypeThink tankFocusConducts and scrutinizes research to improve the health and safety of adults and childrenLocationWashington D C ProductHealth and medical information and assistanceKey peopleDiana Zuckerman PresidentWebsitewww wbr center4research wbr orgIn 2014 the organisation changed its name from the National Research Center for Women amp Families to the National Center for Health Research Contents 1 Research 2 Awards 3 Publications 4 References 5 External linksResearch editIn February 2011 Center staff published a study in Archives of Internal Medicine which evaluated the Food and Drug Administration FDA s recalls of devices that the agency considered potentially deadly or otherwise very high risk 2 Using FDA data the authors determined that most of the devices that were high risk recalls had never been studied in clinical trials prior to FDA approval and that the FDA needed to use more stringent criteria for implanted medical devices and those used to diagnose serious illnesses and an editorial in the same issue agreed 3 The study resulted in a hearing in the U S House of Representatives four days later and major U S newspapers and network news programs where device industry representatives argued that clinical trials were not needed and the cost of doing the studies would interfere with job growth and innovation 4 In April 2011 president Diana Zuckerman testified before the U S Senate Special Committee on Aging about the study findings 5 failed verification In 2014 the organisation published a study in the JAMA Internal Medicine journal about the scientific evidence submitted to the FDA to support the marketing of implanted medical devices under the agency s 510 k review process The study concluded that most of the implanted devices were not required to submit data from clinical trials or scientific evidence of safety or effectiveness before they could be sold citation needed In 2016 a study was published in the same journal about recently approved cancer drugs that had been criticized by other researchers as having no evidence that they decreased mortality or helped patients live longer The Center s follow up study found no new evidence that any of the drugs affected survival and only one of the drugs had clear evidence of improving patients quality of life The study also found that the cost of the drugs ranged from 20 000 to 180 000 despite the lack of scientific evidence of benefit citation needed In 2017 staff published a paper in Milbank Quarterly criticizing the FDA for its failure to safeguard electronic health records and other device software from hacking and other cybersecurity threats They stated current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market 6 They added that legislative changes resulting from the law entitled the 21st Century Cures Act will further deregulate health IT reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients The center published another study in Milbank Quarterly in 2018 called Diversity in Medical Device Clinical Trials Do We Know What Works for Which Patients 7 The study investigated whether new high risk medical devices had been proven safe and effective for women minorities or patients over 65 years of age Despite a law encouraging diversity in clinical trials submitted to the FDA the results indicated that most studies did not conduct subgroup analysis on all these major demographic groups thus providing no information about safety or effectiveness for most patients citation needed Awards editTwo awards are given by the center each year The Foremother Lifetime Achievement Award recognizes women who expanded women s horizons improved our communities and made remarkable contributions to our country 8 The Health Policy Heroes Award honors men and women and sometimes boys and girls who have changed the public debate and public policies in ways that help to improve the lives of adults and children nationwide 8 Publications editFox Rawlings Stephanie R Gottschalk Laura B Doamekpor Lauren A Zuckerman Diana M September 2018 Diversity in Medical Device Clinical Trials Do We Know What Works for Which Patients The Milbank Quarterly 96 3 499 529 doi 10 1111 1468 0009 12344 PMC 6131322 PMID 30203600 Ronquillo Jay G Zuckerman Diana M September 2017 Software Related Recalls of Health Information Technology and Other Medical Devices Implications for FDA Regulation of Digital Health The Milbank Quarterly 95 3 535 553 doi 10 1111 1468 0009 12278 PMC 5594275 PMID 28895231 Zuckerman Diana Doamekpor Lauren Abla June 2015 More data are needed for Essure hysteroscopic sterilization device Contraception 91 6 520 doi 10 1016 j contraception 2015 02 027 PMID 25779602 Gonsalves G Zuckerman D 25 March 2015 Commentary Will 20th century patient safeguards be reversed in the 21st century BMJ 350 mar25 7 h1500 doi 10 1136 bmj h1500 PMID 25814537 S2CID 19510018 Zuckerman Diana Brown Paul Das Aditi 1 November 2014 Lack of Publicly Available Scientific Evidence on the Safety and Effectiveness of Implanted Medical Devices JAMA Internal Medicine 174 11 1781 7 doi 10 1001 jamainternmed 2014 4193 PMID 25265047 Zuckerman Diana M Brown Paul Nissen Steven E 13 June 2011 Medical Device Recalls and the FDA Approval Process Archives of Internal Medicine 171 11 1006 11 doi 10 1001 archinternmed 2011 30 PMID 21321283 References edit Home Page National Center for Health Research Retrieved 2022 09 08 Zuckerman Diana M Brown Paul Nissen Steven E 13 June 2011 Medical Device Recalls and the FDA Approval Process Archives of Internal Medicine 171 11 1006 11 doi 10 1001 archinternmed 2011 30 PMID 21321283 Redberg Rita F Dhruva Sanket S 13 June 2011 Medical Device Recalls Get It Right the First Time Archives of Internal Medicine 171 11 1011 2 doi 10 1001 archinternmed 2011 27 PMID 21321286 News Analysis Interviews Op eds amp Editorials National Center For Health Research National Center for Health Research Retrieved 8 August 2015 Home United States Senate Special Committee on Aging United States Senate Retrieved 8 August 2015 Ronquillo Jay G Zuckerman Diana M September 2017 Software Related Recalls of Health Information Technology and Other Medical Devices Implications for FDA Regulation of Digital Health The Milbank Quarterly 95 3 535 553 doi 10 1111 1468 0009 12278 PMC 5594275 PMID 28895231 Fox Rawlings Stephanie R Gottschalk Laura B Doamekpor Lauren A Zuckerman Diana M September 2018 Diversity in Medical Device Clinical Trials Do We Know What Works for Which Patients The Milbank Quarterly 96 3 499 529 doi 10 1111 1468 0009 12344 PMC 6131322 PMID 30203600 a b Foremother and Health Policy Hero Awards Luncheon National Center for Health Research 7 May 2018 Retrieved 17 September 2019 External links editOfficial website Retrieved from https en wikipedia org w index php title National Center for Health Research amp oldid 1180388938, wikipedia, wiki, book, books, library,
