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National Center for Health Research

The National Center for Health Research (formerly the National Research Center for Women & Families) is a Washington, D.C.-based non-profit organization founded in 1999. It uses objective, research-based information to encourage new, more effective programs and policies that promote the health and safety of women, children, and families. The center educates patients, consumers, and health professionals through its articles, trainings, and media, and educates policymakers and analysts about the latest research at briefings, hearings, and meetings. The President of the National Center is Diana Zuckerman. The primary program is The Cancer Prevention and Treatment Fund, which has an online health hotline and provides free, research-based information and services to patients and their families.

National Center for Health Research
NCHR logo .png
Founded1999
FounderDiana Zuckerman
TypeThink tank
FocusConducts and scrutinizes research to improve the health and safety of adults and children
Location
ProductHealth and medical information and assistance
Key people
Diana Zuckerman, President
Websitecenter4research.org

In 2014, the think tank changed its name from the National Research Center for Women & Families to the National Center for Health Research.

Contents

ResearchEdit

In February 2011, Center staff published a study in the peer-reviewed journal 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.[1] 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.[2] 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.[3]

In April 2011, Center president Diana Zuckerman testified before the U.S. Senate Special Committee on Aging about the study findings.[4]

In 2014, Center staff published a study in the peer-reviewed JAMA Internal Medicine 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 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, Center staff published a study in the peer-reviewed JAMA Internal Medicine 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 the peer-reviewed policy journal 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”.[5] 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?”.[6] 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 analyses on all these major demographic groups, thus providing no information about safety or effectiveness for most patients.[citation needed]

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. 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, 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.
  • 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

  1. ^ 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.
  2. ^ 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.
  3. ^ "News Analysis: Interviews, Op-eds, & Editorials - National Center For Health Research". National Center for Health Research. Retrieved 8 August 2015.
  4. ^ "Home - United States Senate Special Committee on Aging". United States Senate. Retrieved 8 August 2015.[failed verification]
  5. ^ 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.
  6. ^ 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. PMC 6131322. PMID 30203600.

External linksEdit