Leading health researchers have urged Africans to embrace clinical trials, emphasising their vital role in addressing local health challenges and boosting economic opportunities. Ahead of the 2024 Impact Africa Summit in Lagos, the group of experts highlighted the need to create a robust and sustainable clinical trial ecosystem in Sub-Saharan Africa. They noted that this

The post Improving Representation in Clinical Trials and Research: Building Research Equity for Women and Underrepresented Groups was curated by information for practice.

Marijuanas active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials.

Mobilization of a rapid and robust clinical research program that explores whether investigational therapeutics and vaccines are safe and effective to combat the next infectious disease epidemic will depend on strengthening capacity in low-income countries for response and research, engaging people living in affected communities, and conducting safety trials before an epidemic hits, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Lack of representation in research is compounding disparities in health outcomes, with serious consequences for underrepresented groups and the nation as a whole. Urgent actions are needed by NIH, FDA, and others to boost representation of racial and ethnic minority groups and other underrepresented populations in clinical trials and research.

The Drug-Releasing Contact Lens Contains a Broad-Spectrum Antibiotic

Personalized and targeted medicine for rare lung and other cancers

Location: Electronic Resource- 

Title: Men Should be Included in Breast Cancer Clinical Trials: FDA
Category: Health News
Created: 8/26/2019 12:00:00 AM
Last Editorial Review: 8/27/2019 12:00:00 AM

An AllTrials report for the House of Commons Science and Technology Select Committee this week has found that 33 NHS trust sponsors and six UK universities are reporting none of their clinical trial results, while others have gone from 0% to 100% following an announcement from the Select Committee in January that universities and NHS […]

New research has shown that the majority of clinical trials which should be following the US law on reporting results aren’t. Less than half (41%) of clinical trial results were reported on time and 1 in 3 trials (36%) remain unreported. The research also found that clinical trials sponsored by companies are the most likely […]

A judge in New York has ruled that hundreds of clinical trials registered on ClinicalTrials.gov are breaking the law by not reporting results. The ruling came in a court case launched against the US Department of Health and Human Services by two plaintiffs, a family doctor and a professor of journalism. The case focused on […]

This morning I ran across a bit of a coffee-spitter: in the middle of an otherwise opaquely underinformative press release fromTranscelerate Biopharma about the launch of their

"Locating and accessing these comparators at the right time, in the right quantities and with the accompanying drug stability and regulatory information we need, doesn't always happen efficiently. This is further complicated by infiltration of the commercial drug supply chain by counterfeit drugs.  With the activation of our Comparator Network the participating TransCelerate companies will be able to source these comparator drugs directly from each other, be able to secure supply when they need it in the quantities they need, have access to drug data and totally mitigate the risk of counterfeit drugs in that clinical trial."

Counterfeit drugs have even been known to have been involved in clinical drug trials.^{[citation needed]}

Clinical Trials market in India has shown significant growth symptoms in the recent past

The Centre should not relax its clinical trials norms unless the situation is exceptional or dire

The rush to get the medicine was a quick one and the minister's phone has not stopped ringing since he returned

Cadila Pharmaceutical will seek the govt's nod in two days for initiating clinical trials for a vaccine against swine flu.

Marijuanas active components are potentially effective in treating pain, nausea, the anorexia of AIDS wasting, and other symptoms, and should be tested rigorously in clinical trials.

Mobilization of a rapid and robust clinical research program that explores whether investigational therapeutics and vaccines are safe and effective to combat the next infectious disease epidemic will depend on strengthening capacity in low-income countries for response and research, engaging people living in affected communities, and conducting safety trials before an epidemic hits, says a new report from the National Academies of Sciences, Engineering, and Medicine.

For some patients, the ability to participate in a clinical trial from the comfort of one’s home is becoming a reality.

Individuals with Severe COPD Encouraged to Inquire About Participation in the Study

Margaret Parker, MD, FCCM, speaks with Victoria L. Pemberton, RN, MS, about her article published in the January Pediatric Critical Care Medicine

New York's Gov. Andrew Cuomo plans to pursue the treatment following its relative success in treating influenza and Ebola.

The post FDA Okays Historic Blood Treatment for COVID; Clinical Trials to Use Antibodies From Recovered Patients appeared first on Good News Network.

Four NBA players have been confirmed as volunteer blood plasma donors as a means of testing an experimental therapy to treat COVID-19.

The post NBA Players Recovered From COVID-19 Are Donating Plasma to Clinical Trials Helping Sick Patients appeared first on Good News Network.

COVID threatens mountain gorillas and these boots were made for running

We want clinical trials to be thorough - but Vinay Prasad, assistant professor of medicine at Oregon Health Science University, argues that the problem of overdiagnosis may be as prevalent, in the way we measure disease in our research, as our practice. In this podcast he joins us to discuss the problem, and why he thinks what qualifies as...

OBJECTIVE

To determine if the International Hypoglycaemia Study Group (IHSG) level 2 low glucose definition can identify clinically relevant hypoglycemia in clinical trials and offer value as an end point for future trials.

OBJECTIVE

This study evaluated the ability of the Building, Relating, Assessing, and Validating Outcomes (BRAVO) risk engine to accurately project cardiovascular outcomes in three major clinical trials—BI 10773 (Empagliflozin) Cardiovascular Outcome Event Trial in Type 2 Diabetes Mellitus Patients (EMPA-REG OUTCOME), Canagliflozin Cardiovascular Assessment Study (CANVAS), and Dapagliflozin Effect on Cardiovascular Events–Thrombolysis in Myocardial Infarction (DECLARE-TIMI 58) trial—on sodium–glucose cotransporter 2 inhibitors (SGLT2is) to treat patients with type 2 diabetes.

Clinical trials in children with severe traumatic brain injury (TBI) are challenging. To date, no work has been published that permits clinical investigators to estimate the number and compositional features of sites from which to recruit children with severe TBI into clinical trials.

Children with severe TBI are infrequent. Less than 5% of all US hospitals discharged more than 78% of severe TBI cases. To maximize enrollment efficiency for future clinical trials, attention has to be paid to selecting appropriate hospital sites. (Read the full article)

There are limited data regarding the current status of the pediatric clinical trial enterprise.

Evaluation of the ClinicalTrials.gov data set allows description of the overall portfolio of clinical trials relevant to US children, which was previously not possible. (Read the full article)

There is concern about the potential exploitation of children who are enrolled into clinical trials in developing and transition countries. Previous studies of globalization have only examined pediatric drug trials, and only 1 study has provided patient-level data by country.

The involvement of developing and transition countries depends on the product or indication under investigation and is greater for vaccines than for drugs or biologicals. Compared with our previous analysis, involvement of these countries in pediatric drug development has decreased. (Read the full article)

The intestinal microbiome may play a role in immune system maturation, and it has been postulated that early-life probiotic administration may reduce the risk of allergies and asthma in childhood. To date, however, results from clinical trials have been inconsistent.

In this meta-analysis, administration of probiotics in early life may reduce total immunoglobulin E level and protect against atopic sensitization but do not seem to protect against asthma/wheezing. Future trials should carefully select probiotic strains and include longer follow-up. (Read the full article)

Fewer clinical trials are performed in children compared with other patient populations. It is unknown how well existing pediatric clinical trials are aligned with the needs of children, both in high-income countries and globally.

There is only moderate correlation between clinical trial activity and pediatric burden of disease, with certain conditions substantially underrepresented in the current research portfolio. Our findings provide a benchmark for prioritizing conditions for study, analyzing gaps, and identifying funding priorities. (Read the full article)

Background: This study summarizes drug resistance analyses in 4 recent phase 2b trials of the respiratory syncytial virus (RSV) fusion inhibitor presatovir in naturally infected adults.

Methods: Adult hematopoietic cell transplant (HCT) recipients, lung transplant recipients, or hospitalized patients with naturally acquired, laboratory-confirmed RSV infection were enrolled in 4 randomized, double-blind, placebo-controlled studies with study-specific presatovir dosing. Full-length RSV F sequences amplified from nasal swabs obtained at baseline and postbaseline were analyzed by population sequencing. Substitutions at RSV fusion inhibitor resistance-associated positions are reported.

Results: Genotypic analyses were performed on 233 presatovir-treated and 149 placebo-treated subjects. RSV F variant V127A was present in 8 subjects at baseline. Population sequencing detected treatment-emergent substitutions in 10/89 (11.2%) HCT recipients with upper and 6/29 (20.7%) with lower respiratory tract infection, 1/35 (2.9%) lung transplant recipients, and 1/80 (1.3%) hospitalized patients treated with presatovir; placebo-treated subjects had no emergent resistance-associated substitutions. Subjects with substitutions at resistance-associated positions had smaller decreases in viral load during treatment relative to those without, but similar clinical outcomes.

Conclusions: Subject population type and dosing regimen may have influenced RSV resistance development during presatovir treatment. Subjects with vs without genotypic resistance development had decreased virologic responses but comparable clinical outcomes.

India has turned to its age-old medicinal practice of Ayurveda to check if it can work against novel Coronavirus.

Korean biopharma company, PharmAbcine, is commencing full-scale clinical trials of a brain cancer treatment in the United States, following pioneering early phase trials in Australia.

Implications of Covid-19 on the conduct of clinical trials The current Covid-19 pandemic’s impact on European healthcare systems, such as limited or no patient contact; restricted site access; shortage of investigational medicinal products; t...

Title: Analysis Finds Clinical Trials Often Small, of Poor Quality
Category: Health News
Created: 5/1/2012 6:05:00 PM
Last Editorial Review: 5/2/2012 12:00:00 AM

Dramatically rising costs in drug development are in large part because of the high failure rates in clinical phase trials. The poor correlation of animal studies to human toxicity and efficacy have led many developers to question the value of requiring animal studies in determining which drugs should enter in-human trials. Part 1 of this 2-part series examined some of the data regarding the lack of concordance between animal toxicity studies and human trials, as well as some of the potential reasons behind it. This second part of the series focuses on some alternatives to animal trials (hereafter referred to as animal research) as well as current regulatory discussions and developments regarding such alternatives.

In low-dose computed tomography (LDCT) screening for lung cancer, all three main conditions for overdiagnosis in cancer screening are present: 1) a reservoir of slowly or nongrowing lung cancer exists; 2) LDCT is a high-resolution imaging technology with the potential to identify this reservoir; and 3) eligible screening participants have a high risk of dying from causes other than lung cancer. The degree of overdiagnosis in cancer screening is most validly estimated in high-quality randomised controlled trials (RCTs), with enough follow-up time after the end of screening to avoid lead-time bias and without contamination of the control group.

Nine RCTs investigating LDCT screening were identified. Two RCTs were excluded because lung cancer incidence after the end of screening was not published. Two other RCTs using active comparators were also excluded. Therefore, five RCTs were included: two trials were at low risk of bias, two of some concern and one at high risk of bias. In a meta-analysis of the two low risk of bias RCTs including 8156 healthy current or former smokers, 49% of the screen-detected cancers were overdiagnosed. There is uncertainty about this substantial degree of overdiagnosis due to unexplained heterogeneity and low precision of the summed estimate across the two trials.

Pemigatinib was effective in patients with cholangiocarcinomas with FGFR2 fusions or rearrangements.

The FGFR2b inhibitor bemarituzumab was effective in high-FGFR2b gastroesophageal adenocarcinoma.

Patients with HPV16⁺ cervical cancer and high T-cell responses to an HPV16 vaccine survived longer.

Leading medical experts have described trials for a drug which could treat coronavirus as "a really promising first step" towards overcoming the disease.

Australian scientists also working to evaluate extent of immunity to virus among public

Washington, DC – October 24, 2017 – On October 19 ACRO Executive Director Doug Peddicord, Ph.D., testified at a public hearing of...