PRESS-NEWS.org - Press Release Distribution
PRESS RELEASES DISTRIBUTION

Caring is sharing: Call for more openness on cancer drug trial results

2023-11-21
(Press-News.org) Development of potential or improved anti-cancer treatments are being blocked or slowed down by lack of transparency in data sharing between pharmaceutical companies and research groups, according to cancer clinicians, researchers and consumers.  

The multidisciplinary team led by Flinders University researchers Mr Natansh Modi and Dr Ashley Hopkins evaluates the literature and policy developments since the 2013 data sharing commitments were struck by US and European regulators, including the commitment to publish clinical trial results.  

The agreement forged by the Pharmaceutical Research and Manufacturers of America (PhRMA) and European Federation of Pharmaceutical Industries and Associations (EFPIA) included a commitment to give public access to clinical study reports from clinical trials submitted to the Food and Drug Administration (FDA), European Medicines Agency and EU member states.  

However, the new article published in BMC Medicine identifies critical areas for improvement in data sharing and collaboration within the pharmaceutical industry – as well as among all institutions involved in clinical trials.   

“It will take even more commitment, time and resources to make a collective effort to enhance the accessibility and transparency of critical data in clinical trials,” says NHMRC PhD candidate Mr Modi, from the Clinical Cancer Epidemiology Lab at the Flinders University College of Medicine and Public Health.  

“We have identified a series of evidence-based recommendations to enhance existing principles, promote harmonized data sharing practices, and establish clearer guidelines for pharmaceutical industry data sharing.” 

Senior Research Fellow in Pharmacology Dr Hopkins, adds the Clinical Cancer Epidemiology Lab research is focusing on the “substantial opportunity to enhance the data sharing ecosystem” including ensuring that clinical trials deemed as eligible for sharing be made “truly accessible” and that individual-participant data (IPD) packages meet a “standard of utility”.   

In a recent study, the researchers were allowed access to 70 or 77% of IPDs from 91 trials of FDA-approved anticancer medicines against solid tumours, carried out in the 12 months to February 9 2023. Access was denied to the remaining 21 trials, and completeness of the data and supporting documentation was variable.  

As a result, the BMC Medicine correspondence is calling for updates in sharing and accessibility of participant-level data, clinical study reports, protocols, statistical analysis plans, lay summaries and result publications from pharmaceutical industry-sponsored trials. 

Some key recommendations include: 

IMMEDIATE eligibility for sharing participant-level data from any clinical trial underpinning a product label or submitted for drug approval. 

PUBLIC availability of full Clinical Study Reports from all clinical trials submitted to support medicine approvals for direct download. 

SHARING protocols and Statistical Analysis Plans for all published clinical trials within six months of enrolling the first participant. 

PROVIDE lay summary documents to all clinical trial participants within 12 months of primary outcome completion, to comply with the European Union Clinical Trials Regulation.  

DISSEMINATION of clinical trial results and result publications not dependent on clinical trial outcome or phase, covering all follow-up data. 

PHARMACEUTICAL companies should have publicly available web pages detailing their data sharing policies, procedures and commitments in a standardided format. 

“The proposed policy and process updates should also cover institutions such as universities, medical societies, advocacy groups, regulators, funders and journals involved in reporting and carrying out clinical trials,” Mr Modi says.  

“The ultimate goal is to create a data sharing ecosystem that prioritizes science and patient-centered care, benefitting all stakeholders in the field.”  

The correspondence, entitled ‘A 10-year update to the principles for clinical trial data sharing by pharmaceutical companies: perspectives based on a decade of literature and policies’ (2023) by Natansh D Modi, Ganessan Kichenadasse, Tammy C Hoffmann, Mark Haseloff, Jessica M Logan, Areti A Veroniki, Rebecca L Venchiarutti, Amelia K Smit, Haitham Tuffaha, Harindra Jayasekara, Arkady Manning-Bennet, Erin Morton, Ross A McKinnon, Andrew Rowland, Michael MJ Sorich, Ashley M Hopkins has been published in BMC Medicine. 

https://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03113-0 

Collaborators on the article include researchers from Bond University, University of South Australia, University of Toronto, Flinders Centre for Innovation in Cancer, The University of Sydney, The University of Queensland, The University of Melbourne, Monash University, and other clinical trial organisations.   

END


ELSE PRESS RELEASES FROM THIS DATE:

Calls for improved support about menstruation changes during perimenopause

2023-11-21
Perimenopausal women need better education and support about how their periods might change towards the end of their reproductive life, finds a new study led by UCL researchers. The research, published in Post Reproductive Health, highlighted how as women approach the menopause, their periods may become unpredictable, heavy and cause worse premenstrual symptoms – including mood swings, breast tenderness and headaches. The team of researchers from the UCL EGA Institute of Women’s Health and Centre for Reproductive Health, University of Edinburgh, ...

Why emotions stirred by music create such powerful memories

2023-11-20
Key takeaways UCLA psychologists used music to manipulate emotions of volunteers and found the dynamics of their emotions molded otherwise neutral experiences into memorable events. The tug of war between integrating memories and separating them helps to form distinct memories, allowing people to understand and find meaning in their experiences, and retain information. These findings could hold therapeutic promise in helping people with PTSD and depression. Time flows in a continuous stream — yet our ...

Low-quality studies on early interventions for autism dominate the field, says researchers

Low-quality studies on early interventions for autism dominate the field, says researchers
2023-11-20
CHAPEL HILL, N.C. – The Centers for Disease Control and Prevention report that autism is becoming more common in young children. In an effort to improve the challenges young autistic children face as part of their early development, researchers have focused on developing and evaluating nonpharmaceutical interventions that can be provided in early childhood. Micheal Sandbank, PhD, an assistant professor in the Department of Health Sciences at the UNC School of Medicine, is an expert on the research supporting these early interventions, which informs clinical practice across the United States. A new comprehensive meta-analysis, led by Sandbank, shows that many low-quality ...

Study finds possible early predictor of successful transcranial magnetic stimulation therapy for major depression

2023-11-20
A new study from UCLA Health researchers demonstrates that a novel treatment is effective in most patients with major depressive symptoms even after multiple failed courses of antidepressant medication. The treatment, repetitive transcranial magnetic stimulation (rTMS), may work even more rapidly than past findings have suggested, starting to alleviate symptoms as quickly as one week. Researchers from the Neuromodulation Division of UCLA’s Semel Institute analyzed the outcomes of hundreds of patients treated at UCLA Health from 2009 to 2022 with rTMS therapy, which uses magnetic fields to effectively “rewire” ...

Trend report: High blood pressure increasing in low-income adults; diabetes and obesity on the rise in higher-income adults

2023-11-20
Embargoed for release until 5:00 p.m. ET on Monday 20 November 2023 Annals of Internal Medicine Tip Sheet @Annalsofim Below please find summaries of new articles that will be published in the next issue of Annals of Internal Medicine. The summaries are not intended to substitute for the full articles as a source of information. This information is under strict embargo and by taking it into possession, media representatives are committing to the terms of the embargo not only on their own behalf, but also on behalf of the organization they represent. ---------------------------- 1. ...

More than 1,100 physicians, health care professionals, and scientists boycott medical journal

2023-11-20
WASHINGTON, D.C. — More than 1,100 experts have joined the Physicians Committee for Responsible Medicine in boycotting the medical journal Nutrients until it stops publishing egregious animal experiments that could have been ethically conducted in humans. The boycott, which also applies to Nutrients’ publisher, MDPI, comes after repeated requests to the journal’s editors asking them to institute sound editorial practices. A letter sent to those editors today, Nov. 20, 2023, says “As a community of scientists and health care professionals, we have ...

Urban environmental exposures drive increased breast cancer incidence

2023-11-20
DURHAM, N.C. – A Duke Health analysis of breast cancer in North Carolina showed that the state’s urban counties had higher overall incidences of disease than rural counties, especially at early stages upon diagnosis.   The findings, appearing in the journal Scientific Reports, serve as a national template for assessing the impact of poor environmental quality across different stages of breast cancer, which is marked by highly diverse origins and mechanisms for spreading. North Carolina serves as a good model; it has a diverse population ...

C-sections in Mexico increase with obesity level and health care specialization

2023-11-20
URBANA, Ill. — Cesarean section (C-section) procedures have increased dramatically around the world in the recent decades. Overweight and obesity rates, common risk factors for pregnancy outcomes and for C-sections, are also on the rise — creating a major health issue in low- and middle-income countries. A new study from the University of Illinois Urbana-Champaign investigates how high obesity levels lead to hospital specializations that affect the frequency of C-sections in Mexico. “Of course, obesity is a medical factor for C-sections; however, when we started this project we did not believe it to be the ...

New machine learning technique 30% better at predicting cancer cure rates

New machine learning technique 30% better at predicting cancer cure rates
2023-11-20
With the rapid development in computing power over the past few decades, machine-learning (ML) techniques have become popular in medical settings as a way to predict survival rates and life expectancies among patients diagnosed with diseases such as cancer, heart disease, stroke, and, more recently, COVID-19. Such statistical modeling helps patients and caregivers balance treatment that offers the highest chance of a cure while minimizing the consequences of potential side effects. A professor and his doctoral student at The University of Texas at Arlington have published a new model of predicting survival from ...

Potential therapeutic target found to combat tuberculosis, a disrupted NAD(H) homeostasis

Potential therapeutic target found to combat tuberculosis, a disrupted NAD(H) homeostasis
2023-11-20
BIRMINGHAM, Ala. – It has been uncertain how Mycobacterium tuberculosis deflects the immune response in humans, though evidence has pointed to host immunometabolism — the intrinsic link between metabolism in immune cells and their immune function. The pathogen M. tuberculosis is known to disrupt a metabolic pathway called glycolysis in infected myeloid cells, which include macrophages, through an unclear mechanism. A more accurate understanding of this pathogenic mechanism could provide a target against the bacterium that caused 1.6 million deaths in 2021, along with 10 million new cases of tuberculosis every year. Now a study published ...

LAST 30 PRESS RELEASES:

Endophytic fungi from halophyte Sesuvium portulacastrum enhance maize growth and salt tolerance

Quality of kids’ diets linked with dad’s eating habits as a teen

Alliance trial shows dual immunotherapy improves progression-free survival in advanced squamous cell skin cancer

Insights from immunotherapy trial inform new approaches to treating advanced skin cancer

Genome breakthrough reveals secrets behind rapid growth and invasiveness of tropical vine Merremia boisiana

Transforming the certification process of 3D-printed critical components

UC Davis clinical trial shows biomarkers hold clue in treating aggressive prostate cancer

UT Health San Antonio researchers discover new links between heart disease and dementia

AADOCR announces new SCADA/Dentsply Sirona Research Award

Mass General Brigham researchers present key findings at ASCO

Student researchers put UTA on national stage

Hertz Foundation and Breakthrough Energy partner to advance climate and energy solutions

New study reveals how tiny insects detect force

New 3D genome mapping technology sheds light on how plants regulate photosynthesis

Dinosaur eggshell study confirms biogenic origin of secondary eggshell units

Transforming immunotherapy design

New book with a global view of men’s experiences with partner violence

New research recovers evidence for lost mountains from Antarctica’s past

Scientists discover new evidence of intermediate-mass black holes

Predicting underwater landslides before they strike

What will it take to reduce primary care doctor burnout?

Small currents, big impact: Satellite breakthrough reveals hidden ocean forces

Single-atom catalysts change spin state when boosted by a magnetic field

Integrated metasurface for quantum analog computation: A new scheme to phase reconstruction

PolyU research reveals rising soil nitrous acid emissions driven by climate change and fertilisation accelerate global ozone pollution

The EU should allow gene editing to make organic farming more sustainable, researchers say

At-home heart attacks and cardiac deaths on the rise since COVID-19 pandemic

Projected outcomes of removing fluoride from U.S. public water systems

Parental education, own education, and cognitive function in middle-aged and older adults

Sacred moment experiences among internal medicine physicians

[Press-News.org] Caring is sharing: Call for more openness on cancer drug trial results