Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
AM Pease, HM Krumholz, NS Downing, JA Aminawung… - bmj, 2017 - bmj.com
Objective To characterize the prospective controlled clinical studies for all novel drugs that
were initially approved by the Food and Drug Administration on the basis of limited …
were initially approved by the Food and Drug Administration on the basis of limited …
Clinical trial evidence supporting FDA approval of novel therapeutic agents, 2005-2012
NS Downing, JA Aminawung, ND Shah, HM Krumholz… - Jama, 2014 - jamanetwork.com
Importance Many patients and physicians assume that the safety and effectiveness of newly
approved therapeutic agents is well understood; however, the strength of the clinical trial …
approved therapeutic agents is well understood; however, the strength of the clinical trial …
Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010
NS Downing, ND Shah, JA Aminawung, AM Pease… - Jama, 2017 - jamanetwork.com
Importance Postmarket safety events of novel pharmaceuticals and biologics occur when
new safety risks are identified after initial regulatory approval of these therapeutics. These …
new safety risks are identified after initial regulatory approval of these therapeutics. These …
[HTML][HTML] Regulatory review of novel therapeutics—comparison of three regulatory agencies
NS Downing, JA Aminawung, ND Shah… - … England Journal of …, 2012 - Mass Medical Soc
Background The upcoming reauthorization of the Prescription Drug User Fee Act focuses on
improving the review process for new drug applications at the Food and Drug Administration …
improving the review process for new drug applications at the Food and Drug Administration …
History of solitary confinement is associated with post-traumatic stress disorder symptoms among individuals recently released from prison
BO Hagan, EA Wang, JA Aminawung… - Journal of Urban …, 2018 - Springer
This study assessed the relationship between solitary confinement and post-traumatic stress
disorder (PTSD) symptoms in a cohort of recently released former prisoners. The cross …
disorder (PTSD) symptoms in a cohort of recently released former prisoners. The cross …
Transitions clinic network: challenges and lessons in primary care for people released from prison
S Shavit, JA Aminawung, N Birnbaum, S Greenberg… - Health …, 2017 - healthaffairs.org
Low-income and minority communities are disproportionately affected by incarceration,
which exacerbates health disparities. Through enhanced primary care, the Transitions Clinic …
which exacerbates health disparities. Through enhanced primary care, the Transitions Clinic …
[HTML][HTML] Participation of the elderly, women, and minorities in pivotal trials supporting 2011–2013 US Food and Drug Administration approvals
NS Downing, ND Shah, JH Neiman, JA Aminawung… - Trials, 2016 - Springer
Background Pivotal trials, the clinical studies that inform US Food and Drug Administration
(FDA) approval decisions, provide the foundational evidence supporting the safety and …
(FDA) approval decisions, provide the foundational evidence supporting the safety and …
[HTML][HTML] Adherence to the International Committee of Medical Journal Editors'(ICMJE) prospective registration policy and implications for outcome integrity: a cross …
AD Gopal, JD Wallach, JA Aminawung, G Gonsalves… - Trials, 2018 - Springer
Background Registration of clinical trials is critical for promoting transparency and integrity in
medical research; however, trials must be registered in a prospective fashion to deter …
medical research; however, trials must be registered in a prospective fashion to deter …
Health literacy among a formerly incarcerated population using data from the transitions clinic network
Health literacy is increasingly understood to be a mediator of chronic disease self-
management and health care utilization. However, there has been very little research …
management and health care utilization. However, there has been very little research …
Propensity-matched study of enhanced primary care on contact with the criminal justice system among individuals recently released from prison to New Haven
EA Wang, H Lin, JA Aminawung, SH Busch… - BMJ open, 2019 - bmjopen.bmj.com
Background Health systems can be integral to addressing population health, including
persons with incarceration exposure. Few studies have comprehensively integrated state …
persons with incarceration exposure. Few studies have comprehensively integrated state …