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Changing protocol language and site actions are key to making trials inclusive

Changing the language used in trial protocols and continually conversing with sites are some ways by which trialists can make clinical research more inclusive of the LGBTQIA+ community, say experts. On the fourth and final day of the 2024 Summit for Clinical Ops Executives (SCOPE) Summit held in Orlando, a panel discussed the most important changes that can make clinical trials more inclusive of the community. Shir Netanel, associate director of patient advocacy and clinical trial advocacy for Janssen, spoke about her experience with the company launching a transgender-inclusive Phase III trial for prostate cancer. Netanel mentioned how changing the language to be gender neutral, for example, allowed the protocol and eligibility criteria to include any patients who are affected with prostate cancer, regardless of their gender. Additionally, Janssen has also created and deployed a toolkit at trial sites to help investigators be more inclusive, she added. Michel Reid, head ...
- Source: drugdu
- 101
- February 16, 2024
Millions of people to view digital prescriptions via the NHS app

Prescriptions ordered via the app are expected to save around 1.85 million hours in 2024 NHS England has announced that its new digital prescription service has been added to the NHS App. The launch of the service follows a successful trial last year that involved over a million users. In alignment with the NHS campaign to encourage more people to use the app, the digital prescription service will allow millions of patients to see when their prescriptions have been issued and will allow them to view their prescribed medication. Patients who are waiting for an elective hospital treatment will also be able to see the average waiting time for their procedure at their local trust. Users without a nominated pharmacy will be given a barcode via the app to collect their prescription from any pharmacy, as opposed to using a paper version. Anyone with a nominated pharmacy will continue to ...
- Source: drugdu
- 112
- February 16, 2024
NHS launches BRCA testing programme for people of Jewish descent

Individuals with Jewish ancestry are six times more likely to carry a genetic fault The NHS has announced the launch of a new BRCA gene testing programme to identify cancer risk early in individuals with Jewish ancestry. People with Jewish ancestry are about six times more likely to carry a genetic fault, which can increase the risk of developing some cancers, than the general population. Across the next two years, the national NHS Jewish BRCA Testing Programme plans to identify thousands more people carrying faults in the BRCA genes so they can seek early access to surveillance and prevention services. In alignment with the health services drive to catch tumours earlier, when they are easier to treat, anyone over the age of 18 years with Jewish ancestry will be eligible to receive a simple genetic saliva test to look for the presence of BRCA1 or BRCA2 faults. BRCA1 and BRCA2 ...
- Source: drugdu
- 137
- February 16, 2024
New Stool Test for Detecting Colorectal Cancer Could Reduce Unnecessary Colonoscopies

Globally, around 1.9 million people are diagnosed with colorectal cancer each year, resulting in approximately 935,000 deaths. Early detection is key, as colorectal cancer can be cured if found early. However, symptoms like weight loss or blood in the stool often emerge too late for effective intervention. Consequently, many countries have initiated population-based screening programs. These programs commonly utilize the fecal immunochemical test (FIT), which detects the blood protein hemoglobin in stool samples. Colorectal cancer screening programs have been effective in diagnosing the disease at earlier stages and reducing mortality rates. Despite the current test’s effectiveness, there is a need for improvement, particularly in detecting larger premalignant polyps before they become invasive. Early detection would allow for these polyps to be removed during a colonoscopy instead of requiring surgery. Researchers at the Netherlands Cancer Institute (Amsterdam, the Netherlandsl) have been developing a new test, the multitargetFIT-test (mtFIT), which measures hemoglobin ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800242/new-stool-test-for-detecting-colorectal-cancer-could-reduce-unnecessary-colonoscopies.html
- 189
- February 15, 2024
Simple Blood Test Can Predict Heart Attack Risk within Six Months

Heart attacks are the leading cause of death globally, with their incidence on the rise. Despite this, many high-risk individuals either remain unidentified or fail to adhere to preventive treatments. Notably, the period preceding a heart attack is marked by significant biological changes. For instance, the risk of a heart attack doubles in the month following a divorce and increases fivefold in the week after a cancer diagnosis. Based on the hypothesis that several vital biological processes are active during the months before a heart attack, researchers have now suggested that these could be detected using a simple blood test. Researchers at Uppsala University (Uppsala, Sweden) have developed an online tool that, when used in conjunction with standard blood test results, can help clinicians determine if a person is at an elevated risk of experiencing a heart attack within the next six months. The study involved analyzing blood samples from ...
- Source: https://www.labmedica.com/molecular-diagnostics/articles/294800241/simple-blood-test-can-predict-heart-attack-risk-within-six-months.html
- 162
- February 15, 2024
US Senate committee interrogates big pharma on “outrageously high” drug prices

The Senate Health, Education, Labor, and Pensions (HELP) Committee grilled the CEOs of major pharmaceutical companies on what chairman Senator Bernie Sanders labelled “the outrageously high cost of prescription drugs” in the US. Despite intense interrogation, the CEOs made no solid commitments to improve drug prices in the US. The February 8 hearing allowed US senators to question the CEOs of Merck & Co (MSD), Bristol Myers Squibb (BMS) and Johnson & Johnson (J&J) about their drug prices in the US and potential solutions to target high costs. Sanders highlighted price discrepancies between the US and other countries, pointing out that the list price for MSD’s Keytruda (pembrolizumab) is approximately $191,000 in the US, but $112,000 in Canada. On the issue of differential pricing in different countries, BMS CEO Chris Boerner said that the lower prices in countries such as Canada reduced access to essential medications. He said that patients ...
- Source: https://www.pharmaceutical-technology.com/news/us-senate-committee-interrogates-big-pharma-on-outrageously-high-drug-prices/?cf-view
- 293
- February 15, 2024
Hemogenyx gets reprieve as FDA lifts clinical hold on AML CAR-T therapy

Hemogenyx has received the all-clear from the US Food and Drug Administration (FDA) to begin a Phase I clinical trial of its acute myeloid leukaemia (AML) chimeric antigen receptor (CAR) T-therapy in the US. In June 2023, the US FDA placed a clinical hold on the trial for HEMO-CAR-T, requesting additional information from Hemogenyx after a splicing deficiency during manufacture of the lentivirus used to produce CAR-T cells. Hemogenyx produced a plan, supported by laboratory tests to address FDA’s concerns in August 2023, which was accepted the following month. In January, the London, UK-based biopharma issued a complete response to the agency to lift the hold. Hemogenyx’s stock price has increased by 62% following the announcement of the lifting of the hold today (9 February) since the market close yesterday. CAR-T therapies have been hitting the headlines recently after the FDA launched an investigation into the incidence of potentially associated ...
- Source: https://www.pharmaceutical-technology.com/news/hemogenyx-gets-reprieve-as-fda-lifts-clinical-hold-on-aml-car-t-therapy/?cf-view
- 155
- February 15, 2024
International consortium identifies biomarkers for cardiovascular disease in diabetes

Type 2 diabetes is estimated to affect 462 million people worldwide An international academic consortium led by Johns Hopkins University, US, the Chinese University of Hong Kong and Lund University, Sweden, has identified 13 biomarkers that improve the ability to accurately predict the risk of cardiovascular disease in people with type 2 diabetes. The study was conducted by 23 experts across 11 countries as part of an international partnership between the American Diabetes Association and the European Association for the Study of Diabetes, the Precision Medicine in Diabetes Initiative. Estimated to affect around 462 million people globally, type 2 diabetes is a condition that causes too much sugar in the blood. Patients living with the condition are two times more likely to go on to develop cardiovascular disease compared to those without diabetes. Researchers reviewed and analysed the medical studies published from 1990 onward that investigated the differences between people ...
- Source: https://times.com/news/international-consortium-identifies-biomarkers-for-cardiovascular-disease-in-diabetes/
- 212
- February 15, 2024
【EXPERT Q&A】When exporting Class I medical devices, should they be declared for non-medical or medical use?

Drugdu.com expert’s response: The declaration of Class I medical devices as non-medical or medical depends on the specific use of the device and the regulations of the target market. Typically, Class I medical devices refer to low-risk medical equipment, such as surgical instruments and some diagnostic devices. In most cases, these devices are categorized as medical because they are used directly or indirectly for the diagnosis, prevention, monitoring, treatment, or alleviation of diseases. However, if the same type of device is intended for non-medical purposes (for example, solely for cosmetic or personal care), it may be classified as non-medical. In such cases, the classification should be determined based on the actual use of the device and the regulations of the target market. Therefore, when declaring, you should consider the following factors: Purpose of the Device: Is the main use of the medical device for medical or non-medical purposes (such ...
- Source: drugdu
- 158
- February 15, 2024
Electrochemical Sensors with Next-Generation Coating Advances Precision Diagnostics at POC

Current point-of-care (POC) diagnostic technologies are typically limited to measuring a single disease biomarker or several biomarkers from the same class of molecules, such as various RNAs, proteins, or antibodies. However, the ability to measure multiple biomarkers from different molecular classes could provide a more comprehensive understanding of a disease’s state, severity, progression, and individual variations in its development. Electrochemical biosensors, which convert the chemical signal of a biomarker found in a small biofluid sample (like blood, saliva, or urine) into an electrical signal proportional to the biomarker’s amount, could potentially address many diagnostic challenges at the point of care. These sensors can be assembled into multiplexed arrays to detect different biomarkers, and recent advances have overcome the challenge of “biofouling” – the degradation of electrode surfaces by nonspecific biological molecules in samples – through the development of thin antifouling coatings. Now, researchers at Wyss Institute at Harvard University (Boston, ...
- Source: https://www.labmedica.com/clinical-chemistry/articles/294800220/electrochemical-sensors-with-next-generation-coating-advances-precision-diagnostics-at-poc.html
- 124
- February 14, 2024

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