STAT+: In response to criticism, FDA publishes new database of wayward clinical trial sponsors
In a bid toward greater transparency, the U.S. Food and Drug Administration earlier this month…
Category: clinical trials
A nonprofit group is pushing to get estrogen FDA approved for gender-affirming care
Hormone replacement therapies have long been approved by the Food and Drug Administration for use…
How to spot when drug companies spin clinical trial results
Investors, analysts, doctors, and even patients face an avalanche of news from biotech companies about…
STAT+: Most clinical trials run in Canada failed to take basic steps toward transparency, analysis finds
Just 3% of more than 3,700 studies run exclusively in Canada over a recent 10-year…
STAT+: New NIH head says government has fallen behind pharma on clinical trials
WASHINGTON — The new National Institutes of Health director, Monica Bertagnolli, said it’s a “failure”…
STAT+: Ventyx stock craters after lackluster mid-stage trial results for psoriasis drug
SAN DIEGO — Ventyx Biosciences reported on Monday that it was ending development of an…
How skeptical should you be of an after-the-fact subgroup analysis in a failed clinical trial?
This article was adapted from STAT’s latest report, “Subgroup analysis: how to evaluate post hoc…
Breast cancer is deadlier for Black women. A study of mammograms could help close the gap
Are 3D mammograms better than standard 2D imaging for catching advanced cancers? A clinical trial is recruiting…
Opinion: STAT+: How payer-participating trials could help transform clinical research on FDA-approved drugs
Earlier this year, Food and Drug Administration Commissioner Robert M. Califf proposed something radical: that…
STAT Virtual Event | How to Increase Diversity in Clinical Trials: Strategies & Tools
Editor’s note: A livestream of the event will be embedded below at 1 p.m. ET. …
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Opinion: STAT+: The IRA needs changes to better support patients with rare diseases
This time last year, members of Congress were working around the clock to draft and…
STAT+: Here are the dozens of weight loss drugs in development to catch a booming market
The blazing success of weight loss drugs like Wegovy and Mounjaro has electrified the pursuit…
What could fix cancer clinical trials’ longstanding diversity problem?
There’s a diversity problem in cancer clinical trials, and few know this better than Stephanie…
STAT+: Intellia plays down concerns about accidental germline transmission in CRISPR trial
Earlier this month, Intellia Therapeutics announced it was scrapping plans to include U.S.-based sites in…
STAT+: ActiGraph executives on why getting digital endpoints approved for drug trials matters
As drugmakers wade into using digital health technologies, ActiGraph has made its mission to become…
Opinion: The definition of clinical trial diversity must include disabled people
There are people in your life who influence and shape how you see the world….
STAT+: In a rare move, FDA threatens to fine a company for failing to report clinical trial results
For only the fifth time, the U.S. Food and Drug Administration recently threatened to fine…
STAT+: SEC wants to know if key supplier of research monkeys bribed foreign officials
A U.S. government probe into a monkey-smuggling operation emanating from Cambodia has gone in a…
Listen: Your guide to Wegovy’s blockbuster heart study
Is Wegovy the future of cardiology? Can Novo Nordisk ever make enough of it? And…
Failed clinical trials don’t always spell doom for a new drug. Here’s why
This article was adapted from STAT’s latest report, “Failed trial, successful drug: how a negative…
STAT+: Nektar Therapeutics sues Lilly for ‘misconduct’ in drug development deal
A behind-the-scenes feud over a drug development program erupted into public view as Nektar Therapeutics…
NIH begins long-delayed clinical trials for long Covid, announces new research office
WASHINGTON — The National Institutes of Health on Monday took long-delayed steps to begin enrolling patients…
STAT+: European Commission accelerates phasing out animal testing, but stops short of a ban
After months of deliberation, the European Commission has agreed to accelerate the phasing out of…
Doctors use precision medicine to show melanoma drugs can shrink rare brain tumor by 90%
By going down to the molecular level, doctors have uncovered a way to treat tumors…
Opinion: How to separate sound wellness solutions from seductive snake oil
When pandemic lockdowns prevented access to traditional health care facilities, the demand for alternative and…
Opinion: The DNA from dog tumors may hold the secret to better human cancer drugs
This year, nearly 6 million dogs in the U.S. will receive a cancer diagnosis. That’s…
Opinion: The FDA needs a risk evaluation and mitigation strategy for Alzheimer’s drug lecanemab
Over the past several months, my conversations with colleagues in the Alzheimer’s field have featured…
STAT+: Bellerophon Therapeutics trial fails despite innovative digital endpoint
In an important reminder that plugging digital tools into a clinical trial will not magically…
Opinion: STAT+: An overlooked way to make participants in clinical trials look more like America
A recent report from the National Academies of Sciences, Engineering and Medicine (of which one…
STAT+: U.K. unveils $800 million package to bolster life sciences amid concern over biopharma investments
LONDON — The U.K. government on Thursday unveiled an $800 million package to bolster the…
STAT+: In early trial, drug appears to reduce harmful protein buildup in heart
An early-stage drug for a heart disease called ATTR-CM showed potential to reverse disease progression,…
After decades of neglecting women athletes, sport and exercise medicine is finally catching up
When cyclist Alison Tetrick joined the sport’s professional ranks, she received the perks that come…
Gene therapy death not caused by CRISPR, investigators confirm
Terry Horgan, the 27-year-old patient who died eight days after receiving a CRISPR therapy custom-built…
STAT+: CVS Health to close clinical trial unit two years after launch
WOONSOCKET, R.I. — Two years after its launch, CVS Health is planning to close down…
STAT+: Biotech and pharma execs wrestle with the ‘nightmare’ of developing digital biomarkers
TARRYTOWN, N.Y. — As post-lunch drowsiness settled on an auditorium full of leaders from the…
From fusion to retooling cancer trials, Eric Lander wants his new group to ‘go after big problems’
Throughout his storied career, Eric Lander has led science projects in just about every setting…
Opinion: Clinical trials for Alzheimer’s treatments need to include people with Down syndrome
“I cannot tell you how much it means to me that my extra chromosome might…
STAT+: NIH grant recipients often fail to disclose agency support in patent applications
The National Institutes of Health may be the largest public funder of biomedical research in…
STAT+: Scientific research will be threatened unless NIH overhauls systems for tracking non-human primates, report warns
A worsening shortage of non-human primates and an inadequate government response threatens to undermine biomedical…
STAT+: In early glimpse at data, Akili’s video game shows positive results with adults with ADHD
Akili Interactive on Wednesday revealed earlier-than-expected top-line clinical trial results suggesting its video game treatment…
STAT+: Most of Canada’s public research universities get bad grades for ensuring access to drugs they discover
Despite significant public funding, most of the 15 largest public research universities in Canada failed…
STAT+: Early findings in gene therapy death suggest CRISPR was not the cause
In February, four months after the first patient in a designer CRISPR therapy suddenly died,…
Opinion: STAT+: At-home clinical trials are the future
In the early days of the Covid-19 pandemic, much of the clinical trials industry came…
STAT+: Most large U.S. funders of clinical research have poor transparency policies, analysis finds
Amid ongoing concern over clinical trial transparency, a new analysis finds that only 37% of…
Q&A: What does it mean when a clinical trial is delayed? More than you think
Frank David was just starting an independent research program on cell signaling in cancer and…
STAT+: How many? One-third of late-stage trials testing multiple sclerosis drugs were never published
The results from more than one-third of late-stage clinical trials that tested multiple sclerosis drugs…
Here’s a new data point for cancer patients to consider: ‘time toxicity’
When Jeannette Cleland learned earlier this year that she could get chemotherapy at home, after…
STAT+: Liver disease researchers are hoping AI can improve their trial design
Liver disease researchers, stumped by a complex disease, are looking for new investigative tools. Artificial…
STAT+: NIH releases data showing more clinical trial sponsors are reporting results, but most miss deadlines
In response to mounting criticism, the National Institutes of Health published data that shows an…
STAT+: Shortage of monkeys for early-stage research jeopardizes timelines for developing some drugs
A growing shortage of monkeys used for early-stage pharmaceutical research is causing concern that many…