Articles tagged with Clinical Trials
The SPIRIT-Path extension provides evidence-based guidance to standardize pathology content in clinical trial protocols, ensuring methodological rigor and adequate skills and resources. Pathology is integral to trial planning and delivery, and the new guidelines formalize pathology input into clinical trials.
Researchers have identified a way to restore the effectiveness of drugs in clinical trials for treating AML by using human alpha(1)-acid glycoprotein (AGP) as a 'decoy' to bind and inhibit FLT3-mutated leukemia cells. The approach has potential for improving patient outcomes, particularly for patients with FLT3-mutated AML.
New targeted therapies are being developed to target genetic alterations in cancer cells, such as the ARID1A mutation found in 10-50% of solid tumours. Early clinical trials suggest that these agents may be effective in treating multiple cancers, including breast, ovarian, and gastric cancer.
A recent study published in JNCCN found that four out of five cancer therapies tested in Phase III trials did not achieve clinically-meaningful benefits in prolonging survival. The researchers analyzed 362 industry-sponsored trials and found that 87% were either false-positive or true-negative for meeting overall survival goals.
A nationwide team of researchers will investigate epigenetic therapies for cancer, with a focus on exploring new targets and investigating novel combinations. The project aims to improve current epigenetic therapies and enhance existing approaches such as immunotherapy.
The IMpower010 trial demonstrates that atezolizumab significantly improves disease-free survival in resected, early-stage NSCLC patients compared to best supportive care. Tumors expressing PD-L1 > 50% show a greater benefit of treatment.
The FIRSTMAPPP trial found that sunitinib significantly prolongs progression-free survival in patients with malignant pheochromocytoma and paraganglioma. The study demonstrated the efficacy of sunitinib as a treatment option for this rare cancer, which is commonly treated with old and toxic agents.
A parent-led therapy for early signs of autism has significantly reduced the likelihood of an autism diagnosis at age three. The iBASIS-VIPP program uses video-feedback to support social development and unique abilities, resulting in increased parental sensitivity and language development.
The NCI-funded National Clinical Trials Network has added 14 million years of life to people diagnosed with cancer in the US. The network's randomized phase III studies have had a profound impact on cancer research and treatment, influencing over 80% of treatment guideline recommendations.
Researchers discovered that financial incentives effectively increased enrollment in a randomized clinical trial, while also minimizing potential negative effects. The study suggests that incentives can be used to promote research participation, making it an attractive option for future studies.
The MONALEESA-2 trial found that adding a CDK 4/6 inhibitor to first-line hormonal treatment prolongs survival by one year for postmenopausal women with HR-positive, HER2-negative advanced breast cancer. The combination of endocrine therapy and the CDK 4/6 inhibitor ribociclib also extends progression-free survival.
Two phase III trials by VHIO researchers reveal significant clinical activity of trastuzumab deruxtecan in HER2-positive metastatic breast cancer, with over half of patients experiencing two years without disease progression. Trastuzumab duocarmazine also shows promise in treating HER2-negative breast cancer and other tumor types.
A Phase III trial showed a significant overall survival benefit of 63.9 months with ribociclib, compared to 51.4 months with hormone therapy alone. The estimated six-year survival rate was 44.2% with ribociclib, compared to 32% for placebo.
Novartis presents Phase III MONALEESA-2 study results demonstrating improved overall survival with Kisqali (ribociclib) in combination with letrozole. The analysis shows a statistically significant and clinically meaningful improvement in survival, with median OS of 63.9 months.
A novel combination of abiraterone acetate and prednisolone has been shown to prolong survival in patients with hormone/castration-sensitive prostate cancer. Studies PEACE-1 and STAMPEDE found that the addition of these drugs to standard therapy lengthened survival compared to standard therapy alone.
The KEYNOTE-716 trial shows that adjuvant pembrolizumab significantly prolongs recurrence-free survival and halves distant recurrences in stage II B/C melanoma patients. This suggests that patients with high-risk stage II melanoma should be offered adjuvant therapy.
A clinical trial found that over half of patients with non-small cell lung cancer (NSCLC) with a HER2 gene mutation had their tumors stop growing or shrink after treatment with trastuzumab deruxtecan. The drug showed durable responses in 54.9% of patients, with median survival period of 17.8 months.
A new study has shown that a single dose of typhoid conjugate vaccine (TCV) is safe and 84 percent effective in protecting against typhoid in Blantyre, Malawi. The findings are critical as typhoid is an increasing public health threat across sub-Saharan Africa.
Researchers found that patients with low sTK1 levels live longer and have slower disease progression after anti-estrogen treatment. Patients with high sTK1 levels tend to have shorter progression-free survival times and die sooner.
A new study suggests that age does not negatively impact on survival benefit from immune checkpoint inhibitors in elderly patients with stage IV NSCLC. Patients aged 75 and older showed a significant survival benefit from ICIs compared to younger patients.
A two-dose Ebola vaccine regimen has been found to be safe, well-tolerated, and produce a strong immune response in people over 1 year old. The study also supports the use of this regimen for Ebola virus disease prevention in children and adults.
The UK Lung Screening Trial (UKLS) found a significant reduction in lung cancer mortality among high-risk groups through low-dose CT screening. The study, which included over 4,000 participants, showed a 16% relative reduction in lung cancer deaths.
A phase II trial found that high-dose cytarabine followed by pembrolizumab improved cancer remission rates in AML patients, with a complete remission rate of 38%. The treatment also showed promise for patients who had not benefited from standard therapy.
A randomized clinical trial found that students who received eye exams and glasses through a school-based vision program showed improved reading scores and academic achievement over one year. However, these positive effects were not sustained at two years after the program ended.
Researchers found that ribociclib achieved pharmacologically-relevant concentrations in tumor tissue, while everolimus showed minimal penetration. The combination is promising for brain cancer treatment and could lead to new therapeutic drug combinations.
A new antioxidant drug, cysteamine, has been found to reverse atherosclerosis by reducing the oxidation of LDL cholesterol. This process reduces inflammation, damage, and clot formation, ultimately lowering the risk of heart attacks and strokes. Cysteamine was shown to decrease plaque size by up to 56% in mice with atherosclerosis.
Dr. Michael Boyer is the chief clinical officer at The Lighthouse Chris O'Brien comprehensive cancer center in Sydney, Australia. He has been recognized with the Adi F. Gazdar IASLC Merit Award for his pioneering work in molecular pathology and dedication to lung cancer research.
Patients treated by mobile stroke units had faster anti-clot medication delivery and less disability at 90 days compared to standard ambulance care, according to a study published in NEJM. The trial, which enrolled over 1,500 patients, showed that MSU-treated patients were more likely to receive tPA and have better mortality rates.
A study found that 1/3 of cancer drugs with accelerated approval fail to show clinical benefit in post-approval trials yet remain recommended in clinical guidelines. Researchers call for reforms to improve clarity on FDA approvals and withdrawals.
The first-in-human clinical trial for a vaccine to treat opioid use disorders has enrolled its first patients. The vaccine, developed by researchers at the University of Minnesota Medical School, aims to selectively prevent the euphoric and toxic effects of oxycodone.
A novel COVID-19 vaccine candidate demonstrates high efficacy in preclinical models by stimulating the immune system and inducing a robust neutralizing antibody response. The vaccine protects against reinfection and provides better protection than natural immunity, making it a potential supplement to existing vaccines.
A Northwestern University study found that unionizing resident doctors does not reduce burnout, but provides additional benefits such as more vacation time and housing stipends. The study suggests that improving resident wellness requires a program-by-program approach, with implementing wellness toolkits being a promising solution.
The CAPTIVA trial will enroll 1,683 patients with symptomatic intracranial arterial stenosis and determine if two new prospective therapies are more effective than aspirin plus clopidogrel at reducing the risk of a second stroke. Intensive medical management and lifestyle modifications will also be provided to all patients.
A new analytics platform, RDCA-DAP, will be launched to accelerate rare disease treatment innovation by hosting and standardizing rare diseases data. The platform is expected to empower patients and families to drive innovation in the field.
A modified chemotherapy regimen for Burkitt lymphoma has been developed, combining CODOX-M and IVAC with rituximab, to reduce toxicity and improve survival rates. The study found a higher overall survival rate and lower frequency of severe side effects compared to standard regimens.
Researchers from Florida Atlantic University's Schmidt College of Medicine review recent randomized trials, concluding that hydroxychloroquine poses significant harm in treating COVID-19. The study suggests a halt on prescribing the medication, recommending vaccination and masking instead as effective public health strategies.
Researchers from the University of South Australia are conducting a new study to understand what works well and what needs improvement in clinical trials for cancer patients. The study aims to identify barriers to trial participation and inform best practice, ultimately improving access to clinical trials and systems across Adelaide.
A new combination treatment has shown significant tumor shrinkage and prolonged survival in patients with metastatic uveal melanoma. The treatment, which targets HDAC and PD-1 proteins, was found to work better in tumors with active BAP1 genes, a key discovery that may lead to improved survival rates.
The University of Kentucky Center for Clinical and Translational Science has received a $23.5 million award to support groundbreaking health care innovations in Kentucky. The center has successfully catalyzed clinical and translational discoveries, including COVID-19 vaccine trials, with continuous funding since 2011.
A telephone-delivered nursing care strategy combining heart failure care management with depression treatment improved patients' clinical outcomes. Patients receiving 'blended' collaborative care showed better mental health-related quality of life, including improved mood and reduced limitations in social activities.
A large-scale international study found that edoxaban is non-inferior to warfarin for efficacy in preventing adverse events, but led to higher bleeding complications. The trial suggests that treatment with edoxaban can be valuable in managing AF patients after TAVR, especially when a lower dose of edoxaban is used.
A large clinical trial has identified empagliflozin as a treatment option for heart failure with preserved ejection fraction, reducing risk of hospitalization or death by 21 percent. The drug also showed fewer symptoms and mild side effects.
The EMPEROR-Preserved trial found that empagliflozin reduced the risk of a composite of cardiovascular death or hospitalisation for heart failure in patients with heart failure and a preserved ejection fraction. The study showed that empagliflozin was effective across all prespecified subgroups, including those with or without diabetes.
Researchers compared the accuracy of two types of fecal tests for detecting colorectal cancer, finding that both types are reliable when thresholds are adjusted. The study suggests that health providers should select the best type of test based on specific demands in screening settings.
A Rutgers study found that testing for specific inflammatory proteins can help diagnose the earlier onset and progression of Alzheimer's disease. The researchers identified two proteins, TNFR1 and TREM2, which are associated with slower decline in early-stage Alzheimer's, while another protein is only useful once dementia sets in.
A clinical trial has shown that a triple combination therapy consisting of elexacaftor, tezacaftor, and ivacaftor is safe and effective in cystic fibrosis patients with rare genetic defects. The treatment improves CFTR function, lung function, and quality of life in these patients.
A systematic review of federally funded cardiovascular disease trials found that most failed to recruit adequate numbers of Black participants. Despite efforts to improve diversity, enrollment rates have not changed over time, with nearly a quarter of trials not specifying a target percentage of Black enrollees.
A new study suggests that a treatment for canine glioblastoma may also be effective in humans, with some dogs experiencing significant tumor shrinkage. The treatment uses an immunotherapy drug called STING agonist, which induced a robust immune response against cancer cells.
The International Vaccine Institute (IVI) has initiated a Phase II/III clinical trial for the Bharat Biotech Chikungunya vaccine candidate BBV87, evaluating its safety and immunogenicity in healthy adults across five countries. The study aims to develop an affordable vaccine with the aim of achieving WHO prequalification.
The HIPGEN study, a multinational trial, investigates the efficacy and safety of allogeneic placenta-expanded adherent stromal cells to improve recovery after hip fracture arthroplasty. The trial aims to combat immobility and associated problems by strengthening periarticular hip musculature.
Researchers from Okayama University conducted a randomized trial to assess the benefits of interventions for early cancer screening in patients with schizophrenia. The study found that 47.1% of counseled patients underwent colorectal cancer screening, compared to 11.8% of those receiving only usual treatment.
A new study published in The New England Journal of Medicine found that early administration of convalescent plasma did not prevent COVID-19 disease progression in high-risk patients. Despite the strategy's potential, the study suggests that it is not a viable approach to reduce illness severity.
Black, Hispanic, Indigenous and Asian Americans remain underrepresented in pancreatic cancer clinical trials, despite federal mandates. The lack of diversity hurts patients and science alike, with racial and ethnic minorities accounting for a disproportionate burden of pancreatic cancer cases.
A new study reanalyzes the Sorby vitamin C experiment, a landmark trial that determined the minimum vitamin C requirements for preventing scurvy. The analysis suggests that the recommended daily intake of 45mg may be too low to prevent weak scar strength.
A multicenter randomized trial showed acupuncture improved symptoms of moderate to severe CP/CPPS, with effects lasting over 24 weeks. Acupuncture was more effective than sham therapy in reducing symptoms and improving quality of life for men with chronic prostatitis/chronic pelvic pain syndrome.
Researchers found that removing race-based adjustments from equations estimating kidney function could make Black patients ineligible for cancer treatments and lower their doses. The analysis showed that Black patients in the US are more frequently diagnosed with cancer and are more likely to die from it than white Americans.
A new monoclonal antibody called CIS43LS safely prevented malaria for up to nine months in a small clinical trial. The study builds on encouraging early results and will inform additional research to confirm and extend the finding.
A first-of-its-kind study from the University of Pennsylvania School of Nursing clarifies the post-trial needs of patients who withdraw from cancer clinical trials. The study defines what constitutes responsible transitions when patients exit CCTs, providing insights into patient experiences and care after withdrawal.
SK bioscience's GBP510 vaccine candidate has shown promising safety and immunogenic response in Phase I/II clinical trials. IVI will partner with SK on global Phase III trials to accelerate development and WHO approval of the vaccine.
The NIH has launched a pilot study to assess the antibody response of kidney transplant recipients to a third dose of an mRNA COVID-19 vaccine. The trial aims to determine if a third dose can overcome the immune suppression caused by lifelong immunosuppressive therapy in this population.