Search Results < Yale Collaboration for Regulatory Rigor, Integrity, and Transparency (CRRIT)

156 results

News
The painkiller used for just about anything
Gabapentin, approved for seizures and postherpetic neuralgia, has become widely used off-label for ailments like fibromyalgia, neuropathy, and insomnia. Although helpful for some, its side effects and potential for interaction with other drugs raise concerns, especially among older adults. Experts recommend careful use and considering alternative pain management methods.
Source: New York Times
17 Aug 2024
News
The Supreme Court Just Limited Federal Power. Health Care Is Feeling the Shockwaves.
A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s health care system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care. YSPH Professor Dr. Joseph Ross provides insight.
Source: KFF Health News
1 Jul 2024
News
The Supreme Court just limited federal power. Health care is feeling the shockwaves
A landmark Supreme Court decision that reins in federal agencies’ authority is expected to hold dramatic consequences for the nation’s healthcare system, calling into question government rules on anything from consumer protections for patients to drug safety to nursing home care.
Source: ABC News
1 Jul 2024
News
Yale CRRIT Researchers Examine Cancer Drug Guidelines and FDA Approvals
Drugs for serious or life-threatening diseases can receive expedited U.S. Food and Drug Administration (FDA) review, allowing patients to receive faster access to promising new treatments. Under the expedited review pathway of accelerated approval, drugs can be FDA-approved based on surrogate markers or proxy measures such as changes in imaging or lab tests that are “reasonably likely” to predict whether patients improve in how they feel, function, or survive.
26 Jun 2024
News
FDA Use of “Proxies” to Expedite Drug Approvals Not Supported by Evidence, Analysis Finds
Surrogate markers of disease outcome aimed at speeding clinical trials are routinely accepted by the FDA for drug approvals, but most lack the requisite evidence.
28 May 2024
News
Assessing Equity Measures in Hospital Readmissions
A recent collaborative study conducted by Yale researchers sought to apply these methods towards developing a framework for measuring equitable readmissions to the hospital, and to identify hospitals that have equitable rates of readmission.
3 Apr 2024
News
Yale Faculty Present Groundbreaking Clinical Research at the 2024 American College of Cardiology Scientific Sessions
Yale faculty and trainees will present clinical research at the upcoming American College of Cardiology Scientific Meeting.
1 Apr 2024
News
Heckmann and Wong Receive R01 award from National Institute of Mental Health for System Dynamics Modeling to Promote Health Equity in Management of Agitation
A research team led by Ambrose Wong, MD, MSEd, MHS, and Rebekah Heckmann, MD, MPH, MPA, from the Department of Emergency Medicine at Yale School of Medicine, has been approved for a $3.7 million R01 award by the National Institute of Mental Health to address the management of agitation symptoms during mental health crises.
26 Mar 2024
News
Awards & Honors Fall 2023
YSPH faculty honored for their work.
20 Nov 2023
News
Data Sharing — A New Era for Research Funded by the U.S. Government
In late January 2023, the new Data Management and Sharing (DMS) Policy of the National Institutes of Health (NIH), which requires researchers to share data that were generated with NIH support, went into effect. The potential effects of this shift in the clinical research enterprise toward data sharing are profound.
Source: The New England Journal of Medicine
15 Nov 2023
News
Phenylephrine, a Common Decongestant, Is Ineffective, Say FDA Advisors. It’s Not Alone
An FDA advisory committee found that an OTC decongestant, phenylephrine, works no better than a placebo at relieving congestion. Yale researchers discuss how drugs with insufficient evidence make it to market.
5 Oct 2023
News
Yale Open Data Access Project Reaches Milestone in Helping to Maximize the Use of Clinical Trial Data for Research
The Yale Open Data Access (YODA) Project, a pioneering initiative to promote open science and facilitate sharing of clinical trial research data, has reached the milestone of supporting more than 100 publications.
11 Sep 2023
News
Yale-Mayo Clinic CERSI Earns Five-Year FDA Renewal
The Yale-Mayo Clinic FDA Center of Excellence in Regulatory Science and Innovation (CERSI) was recently renewed with an award of up to $50M for five years from the U.S. Food and Drug Administration (FDA). The partnership between Yale School of Medicine (YSM) and Mayo Clinic provides academic scientists the opportunity to perform regulatory science research, training, and education in collaboration with the FDA.
5 Jul 2023
News
When Dying Patients Want Unproven Drugs
Patient-advocacy groups mobilized to demand access to a controversial new drug called Relyvrio. But hasty approval comes at a cost.
Source: The New Yorker
26 Jun 2023
News
Dr. Joseph Ross Named JAMA Deputy Editor
Joseph Ross, MD, MHS, professor of medicine (general medicine), Yale School of Medicine, and of public health (health policy and management), Yale School of Public Health, was recently named deputy editor of the peer-reviewed journal JAMA.
7 Jun 2023
News
Discoveries & Impact (May 2023)
Discoveries & Impact highlights select scientific discoveries across the Department of Internal Medicine...
11 May 2023
News
The pregnancy risks of Ozempic and Wegovy need more attention
Joseph Ross, MD, MHS, weighs in on the risks of using Ozempic and Wegovy during pregnancy.
Source: Vox
18 Apr 2023
News
Discoveries & Impact (March 2023)
Discoveries & Impact highlights select scientific discoveries across the Department of Internal Medicine...
16 Mar 2023
News
1 in 10 FDA-Approved Drugs Miss Primary End Point in Pivotal Trial
New data show the FDA's rationale for approving drugs with unmet efficacy end points in pivotal trials has been inconsistent since at least 2018.
Source: HCPLive
14 Feb 2023
News
2023 American College of Cardiology late-breaking clinical trials and abstracts from Yale
Groundbreaking clinical research at ACC 23.
1 Feb 2023