Tag Archives: clinical

Why Clinical Research Often Fails in Underserved Communities: Key Insights and Solutions

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Explore New Scientist for the latest in science and technology, featuring expert analyses and in-depth articles on health, the environment, and more.

How can I ensure my data is protected? As a young Black physician engaged in clinical research, this question arises frequently in discussions with Black communities in Africa and the Caribbean regarding genetic research participation. The roots of mistrust are not hard to find.

Consider the notorious Tuskegee syphilis study where Black men were left untreated to observe disease progression, even after effective treatments were available. Additionally, Henrietta Lacks’ cells were taken without her consent, fueling extensive research worldwide and generating profit without compensating her family for healthcare needs. This historical context has contributed to the perception of Black individuals as mere research subjects.

In research, it’s understood that quality data is crucial for effective medicine. Unfortunately, Black individuals, along with other underrepresented populations, including non-Europeans and older adults, are often underrepresented in clinical studies. Comprehensive disease understanding requires research across all affected groups to develop inclusive tests and treatments.

Looking ahead, the medical system is shifting towards a genetics-centered approach in patient care. This precision medicine paradigm opts for individualized treatment based on genetic information to enhance prevention and therapeutic efficacy.

However, institutional initiatives from institutions like the University of Exeter and Queen Mary University of London reveal significant gaps in our genetic understanding, particularly in relation to non-European populations. Their findings suggest certain genetic traits in Black people could hinder the accuracy of standard diabetes diagnostic tests, potentially delaying treatment. To bridge this gap, it’s essential to foster trust and increase Black participation in research.

Current research frameworks often unintentionally exclude certain demographics. For instance, if recruitment materials are only available in English or if hiring occurs solely during conventional business hours, valuable contributors may be overlooked. Additionally, relying exclusively on hospitals and universities ignores community hubs like churches and barbershops where people congregate. Recognizing social contexts is vital for effective outreach.

Academic institutions now acknowledge that varying communities necessitate tailored approaches that merge cultural proficiency with scientific rigor. This balance empowers communities and enables research to translate into actionable changes through informed policy and accessible healthcare. It’s essential for researchers to resonate with the communities they serve, fostering trust and relevance through shared experiences.

To address these challenges, researchers must prioritize community involvement from inception rather than merely soliciting input at the end of the process. Funding organizations should integrate community engagement into their budgets, ensuring that incorporating patients and communities becomes a staple in research. This participatory approach can enhance representation among underrepresented groups and ultimately benefit public health. Moreover, researchers must demonstrate reciprocity by contributing to community wellbeing through shared resources and programs.

If you’re interested in participating in research, there are many ways to get involved, from clinical trials to surveys. Every contribution counts.

Dr. Drews Adade – Clinical researcher based in London.

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Source: www.newscientist.com

Reversing Type 2 Diabetes is More Challenging Than Clinical Trials Indicate

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Insulin injections help control type 2 diabetes

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People with type 2 diabetes who lose weight while participating in clinical trials appear to be significantly more likely to have their symptoms reversed than those who lose weight outside of such studies.

Treatments such as insulin injections can help people with type 2 diabetes maintain healthy blood sugar levels. However, if you are overweight or obese, your symptoms may improve when you lose weight.

In fact, less than 10 percent of people with type 2 diabetes who lose weight outside of these trials actually lose weight, even when followed for several years. Wu Hongjian At the Chinese University of Hong Kong. In exams, this number can be closer to 90%.

These discrepancies may be due to sometimes different definitions of what it means to reverse type 2 diabetes, as well as the support and different interventions that often accompany participation in clinical trials. he says.

To better understand this, Dr. Wu and colleagues looked at more than 37,000 people in Hong Kong aged 18 to 75 who were diagnosed with type 2 diabetes between 2000 and 2017, about half of whom were women. ) was studied.

Each participant was followed for an average of just under eight years, and the researchers looked at how their weight changed in the year after diagnosis and whether their symptoms improved during the study period.

The researchers measured glycated hemoglobin (HbA1c) levels, which reflect the participants’ blood sugar status over several months. To reverse type 2 diabetes, also called remission, Generally defined as an HbA1c of less than 6.5 percent. When measured at least 3 months after stopping treatment. The researchers were investigating whether these levels occurred during her two consecutive tests conducted six months apart.

The research team only measured the participants’ weight one year after diagnosis, at which point 2% were in remission and half had gained weight, Wu said.

By the end of the study, 6% were in remission at some point, Wu said. About two-thirds of these people needed diabetes medication to get their symptoms back under control within three years.

However, by simply recording participants’ weight one year after diagnosis, the researchers were not able to determine whether the participants continued to gain weight or whether other factors, such as gaining weight at a particular time, could account for some of the weight. We do not know whether it brought participants out of remission. Fat that accumulates around the waist and certain internal organs.

In contrast, one small clinical trial found that up to 86% of type 2 diabetics who lost at least 15 kg went into remission within 1 year. People participating in such studies often benefit from professional dietary management, physical exercise programs, moral support, regular monitoring, feedback, reminders and encouragement, Wu says.

But even people who participate in the control groups of some clinical trials and don’t undergo intensive weight loss programs have higher remission rates than what was seen in Wu’s team’s study.

That may be because, outside of clinical trials, doctors are often reluctant to advise patients with type 2 diabetes to stop treatment, he says. This likely also has to do with differences in how remission is defined, Wu said, since trials often require only one HbA1c measurement in a healthy patient.

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Source: www.newscientist.com

Next Phase of Human Clinical Trials for Revolutionary Sepsis Treatment Commences

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Scientists have developed a promising treatment for sepsis, and clinical trials using sodium ascorbate, a vitamin C preparation, have shown effective results. The treatment has progressed into extensive clinical trials across Australia and demonstrated significant improvements in sepsis patients, including improved kidney function and reduced dependence on other drugs. This breakthrough, the result of decades of research, brings hope to a disease that is the leading cause of death in intensive care units around the world.

Flory Institute researchers, in collaboration with hospital intensivists, have demonstrated that sodium ascorbate, a pH-balanced formulation of vitamin C, is effective in treating sepsis.

Researchers at the Florey Institute have demonstrated that the formulation they have developed reduces deadly sepsis, and the next phase of clinical trials is set to begin across Australia next month.

Promising results from early clinical trial conducted at Melbourne’s Austin Hospital published in journal Critical carehave shown that sodium ascorbate, a pH-balanced formulation of vitamin C, is effective in treating sepsis.

Lead researcher Associate Professor Yugish Lankadeva said sepsis is notoriously difficult to treat and is often fatal.

LR Florey Professor Clive May, Austin Health Intensivist Professor Rinaldo Bellomo and Florey Associate Professor Yugish Rankadeva discovered that sodium ascorbate can be used to treat sepsis.Credit: Flory

Challenges in sepsis treatment

“Sepsis accounts for 35 to 50 percent of all hospital deaths. It is when the immune system is unable to fight the underlying infection, causing a life-threatening drop in blood pressure, multiple organ failure, and death. ,” said Associate Professor Lankadeva. In our clinical trial at Austin Hospital, sodium ascorbate was administered into patients’ bloodstreams, resulting in promising improvements in multiple organs. ”

Associate Professor Lankadeva, Florey’s research director for Systems Neuroscience, said of the next steps: $4.9 million government-funded research project Delivered in intensive care units in Adelaide, Melbourne, Perth, Brisbane, Alice Springs and Sydney.

“We will recruit 300 adult sepsis patients who will receive either our formulation or a placebo in addition to their usual hospital care. These results will provide additional data to determine the efficacy of the formulation. It will help in collection,” said Associate Professor Lankadeva.

Flory scientists have created a special formulation of sodium ascorbate to treat sepsis.Credit: Flory

Insights into previous trials

Professor Rinaldo Bellomo, director of intensive care research at Austin Hospital, said the first part of the trial at his department involved 30 adult sepsis patients between October 2020 and November 2022.

While in intensive care in the hospital, half of the patients were randomly assigned to receive sodium ascorbate, and the other half received a placebo.

This study found that patients with sepsis treated with sodium ascorbate:

  • Signs that more urine is produced and kidney function has improved
  • Less need for noradrenaline, a drug used clinically to restore blood pressure
  • He showed signs of improved function in multiple organs.

“Sepsis is the number one cause of death in intensive care units in Australia and around the world,” Professor Bellomo said. “In many cases, the disease progresses so rapidly that by the time patients reach us, they are already seriously ill. It will be a huge change.”

Decades of research bear fruit

Professor Clive May, Florey Senior Research Fellow on the project, has been researching how sepsis causes organ failure, particularly damage to the brain and kidneys, for more than 20 years.

“By showing decreased oxygen levels in the tissues of sepsis, we found that sodium ascorbate was a possible treatment.

“We have seen dramatic results in preclinical studies, where extremely high doses of sodium ascorbate caused complete recovery within just three hours with no side effects. It’s heartening to see that it’s paying off and bringing treatments into the hands of patients,” said Professor Clive May.

Surviving sepsis: The patient’s perspective

Longtime Flory staffer Brett Purcell serves as the consumer representative for the MEGASCORES research program, providing a valuable perspective from sepsis survivors.

“In 2011 I was taken to the hospital by ambulance with high fever and delirium. I was suffering from the early stages of sepsis. My condition gradually worsened and I was transferred to a larger hospital after 12 days. By that time My heart was severely infected and I was in septic shock. Six months ago I had a successful aortic valve replacement. Unfortunately the valve was infected.

“The surgical team repaired the damage in a six-hour operation, but my condition deteriorated to critical condition. I was told it would be an hour. It was the good decision-making of the surgical team and ICU intensivist that saved me. I was put on life support with an ECMO machine and dialysis, and my symptoms rapidly worsened. Improved.

“After almost eight weeks in the hospital, I’m home. I’m really lucky to be alive and hope this new research using sodium ascorbate is less invasive, faster, and extremely effective in fighting sepsis.” We hope to provide hospitals with a new and effective life-saving tool.”

Reference: “Ultra-dose sodium ascorbate: pilot, single-dose, physiological effects, double-blind, randomized, controlled trial” Fumitaka Yanase, Sofia Spano, Akinori Maeda, Anis Chaba, Thummaporn Naorungroj, Connie Pei Chen Ow , Yugeesh R. Rankadeva, Clive N. May, Ashenafi H. Betley, Darius JR Lane, Glenn M. Eastwood, Mark P. Plummer, Rinaldo Bellomo, October 12, 2023. Critical care.
DOI: 10.1186/s13054-023-04644-x

Source: scitechdaily.com