The FDA’s Guidance on Conduct of Clinical Trials of Medical Products during the COVID-19 Public Health Emergency, last updated on June 3, contains non-binding recommendations for industry, investigators, and institutional review boards. The recommendations are...
Patient Safety
Category
5 NHS Hospital Patients Have Died Now from Listeria Outbreak
Two more NHS hospital patients have fell ill and died as a result of eating sandwiches contaminated with listeria, health officials have confirmed. It takes the death toll to five, Public Health England (PHE) has reported—after linking a further three cases to the...
Second Patient Death Reported Days After Presentation of Positive Data From Phase 3 STR1VE Trial of Zolgensma for SMA Type 1
Novartis and AveXis (a Novartis company) announced that an investigation is underway into whether a second trial death could be related to gene therapy candidate Zolgensma (onasemnogene abeparvovec-xioi), under development for Spinal Muscular Atrophy (SMA). It was...
Is it Time to Yank Parkinson’s Drug Nuplazid Off the Market?
Nuplazid (pimavanserin) is an atypical antipsychotic which is approved for the treatment of Parkinson’s disease psychosis and is also being researched for the treatment of Alzheimer’s disease psychosis, schizophrenia, agitation, and major depressive disorder. Unlike...
SiteWatch: University of Manitoba Observation Study Compromised Due to Handling of Participant Personal Data
A recent University of Manitoba, Canada was recently audited. It was revealed that 420 participants’ information was handled improperly. The data was kept off campus and violated the Personal Health Information Act. According to CTV News Winnipeg, the study was...
Research, Healthcare and Transparency: Is Information Valuable for the Patient?
TrialSite News recently wrote about the promise and perils of stem cell practices—with a keen eye on unethical and even unlawful medical practices called out the Food and Drug Administration (FDA). We noted that in one Florida case the state medical license board took...
University of PA School of Nursing on Advanced Care Planning with Cancer Clinical Trial Patients
Cancer clinical trials are an important option for patients with cancer. Yet, once a trial ends, patients still need care plans. Little is known at what point during clinical trial transitions to initiate planning discussions or how to educate research teams to...
Hidradenitis Suppurativa and Cancer: Is There a Connection?
Hidradenitis Suppurativa: A Horrible Disease Afflicting Millions Worldwide TrialSite News has been actively covering the serious skin disease and potential autoimmune-related disorder Hidradenitis Suppurativa (HS). Anywhere from 1 to 4 % of the developed world’s...
FDA Reviews Amgen Osteoporosis Drug Despite Cardiovascular Safety Signal
Natalie Grover of ENDPOINTS News reports that the FDA is reviewing romosozumab despite past cardiovascular safety scare. Grover noted the FDA work during horrendous weather and a federal shutdown points toward an interpretation that “the efficacy of the drug in...
Kaiser Permanente Study Shows Flu Vaccine Safe in Hospital
Kaiser announced in EurekAlert! that hospitalized patients who received the flu vaccine had no increased risk of outpatient visits or hospital readmission within seven days of discharge, according to a Kaiser Permanente study published today in Mayo Clinic...
Half-of New Jersey Residents Diagnosed with Alzheimer’s Disease Do Not Receive Referrals to Support Services
A recent survey conducted by Fairleigh Dickinson University’s PublicMind on behalf of Alzheimer’s New Jersey® found that an overwhelming majority of New Jersey residents with memory loss concerns (89%) visited a doctor to seek diagnosis. However, only about half (54%)...
Understanding Therapeutic Misconceptions Associated with Clinical Trial Enrollment
Brandon May writing for Medical Bag notes therapeutic misconception is a trial participant's erroneous belief that that the medical care received during a clinical trial is made for their personal benefit — confusing their role as a patient and a research participant....
Does Accelerating Clinical Research Trials Introduce Risk?
Joel Clark writing for Raconteur writes a provocative piece raising the question that despite the importance of getting life prolonging treatments to patients more quickly, the acceleration of drug trials offers may overlook critical risks according to some...
Breakthrough Immunotherapy Backfires Resulting in Fatal Relapse
As reported in the New York Times by Denise Grady, covering news of work with CAR-T gene therapy reports that “a highly unusual death has exposed a weak spot in the groundbreaking cancer treatment: One rogue cell, genetically altered by the therapy, can spiral out of...
Site Watch: Patient Deaths & Violations Across Connecticut Hospitals
As Brian McReady reports in the Patch, No one wants to go the hospital, but if you do or if a loved one needs to, you're likely going to want to check out this updated searchable in-depth database prepared by the Connecticut Health-Investigative Team. Newly...
UK’s NHS Releases Patient Education Material to Prep for Adalimumab Biosimilar
Samantha DiGrande writing for Center for Biosimilars reports last week the National Health Service’s (NHS) Specialist Pharmacy Service released resources for clinicians to use with patients in the discussions around switching from the reference Humira to a biosimilar....
Thousands of Indians Dying in Unethical Clinical Trials
Samanth Subramanian reports from the National World that thousands of Indians have died in unethical clinical trials over the past decade, even as a lawsuit to improve regulation of these trials has dragged unresolved through the Supreme Court for six years. Between...
Abbvie Paid Docs to Overprescribe Humira, CAL Alleges in Suit
Chicago Tribune writer Sudhin Thanawala reports that pharmaceutical giant AbbVie illegally plied doctors with cash, gifts and services to prescribe one of the world's best-selling drugs, Humira, despite its potentially deadly complications, a California official said...
Irish Parents Denied Access to Life Saving Drugs
According to the Journal I.E., Irish parents are being denied access to a range of different cancer and heart disease medicines because the drugs are still awaiting approval to be used in the Irish system. According to figures published by the Irish Pharmaceutical...
Medicine’s Financial Contamination
Catch the New York Times editorial on the fall of Dr. José Baselga, the former chief scientific officer of Memorial Sloan Kettering Cancer Center, resulting from failure to disclose payments from drug companies.