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Clinical research involves trial and error as part of the drug development process. Learn more about how to optimise drugtrials and the important role of participants in clinical research.
A survey by rare disease patient network Raremark found that 86% of the community members asked were interested in taking part in clinical trials. CEO Jeremy Edwards looks at how decentralised trial models can solve some of the challenges for clinical trial recruitment in rare disease.
Phase 2 trials of Beckley Psytech’s psychedelic drug candidates will make use of digital technologies for patient monitoring, thanks to a new partnership with Empatica. The post Beckley adds digital element to its psychedelic drugtrials appeared first on.
GlaxoSmithKline has suffered another research setback after it axed a phase 2 trial of an anti-LAG3 drug in patients with ulcerative colitis, following a major disappointment with a key lung cancer drug last week. The post GSK suffers another R&D setback, axing ulcerative colitis drugtrial appeared first on.
Pfizer and partner Valneva are scrapping data from roughly half of the participants in a Phase 3 trial of a Lyme disease vaccine candidate after uncovering quality issues with a third-party clinical trial operator. Continue to STAT+ to read the full story…
Lupus is a disease long-plagued by failed clinical trials. And hopeful patients, many of them young women of color, are waiting — just three lupus drugs have been approved by the Food and Drug Administration in six decades. A key partnership is looking to change that.
Small Pharma is following the trend for development of psychedelic medicines, a field where research has been suppressed for years because of legal restrictions on use of these compounds in many countries. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.
Just as clinical researchers in other therapeutic areas have renewed their commitment to improving participant diversity in clinical trials, so too have those working in Alzheimer’s research. Fortunately, there are a number of researchers working on this issue. Similarly, older Latino and Hispanic individuals are 1.5
A former employee of Tellus Clinical Research in Miami has admitted to charges related to a conspiracy to falsify data on a list of clinical drugtrials.
Amid a period of clinical holds and legal tangles, the US antibody specialist CytoDyn has reached a settlement to resolve legal disputes with its former contract research organization (CRO) Amarex Clinical Research.
But before pharmaceutical companies can go to market with a breakthrough drug, they need to ensure safety and efficacy through clinical trials. Pharma R&D teams are solving this problem by leveraging the power of artificial intelligence (AI) in clinical trials to save time and money. Food and Drug Administration approval.
With the acquisition MindMed gains access to HealthMode’s intellectual property, platforms for clinical drugtrials, and its entire 24-strong digital medicine team. Karlin will serve as chief medical officer of MindMed after holding several leadership roles at Pfizer’s Neuroscience Research Unit.
At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. For a clinical trials organization to achieve this level of scale is notable. Recruitment Clinical trial sites live and die by their ability to recruit patients into trials. Velocity is among the few exceptions.
Clinical trials are an essential part of the drug development process. Worldwide, more than 2 million clinical trials are registered and the number is steadily increasing over the past several years. The conduct of trials was not possible due to the risk of catching coronavirus. What are Virtual Clinical Trials?
Clinical trials for pulmonary fibrosis are being conducted to evaluate the effectiveness of novel therapies and interventions, providing hope for improved outcomes in the future. Anti-fibrotic therapies: Anti-fibrotic drugs have shown promise in treating pulmonary fibrosis.
Researchers, including academics from the University of York, analysed systematic reviews of 1,200 Randomised Controlled Trials (RCTs) to assess whether reporting had improved over time.
Researchers are using computer models to simulate COVID-19 infections on a cellular level – the basic structural level of the human body. The models allow for virtual trials of drugs and vaccines, opening the possibility of pre-assessment for drug and vaccine efficacy against the virus.
Expanding minority Americans’ access to care and clinical trials isn’t just the right thing to do. Clinical Trials Don’t Reflect Demographics. Disease doesn’t discriminate, and researchers understand different populations react differently to drugs. Why, then, are clinical trials so stubbornly homogeneous?
Lundbeck has axed a phase 2 trial of a schizophrenia drug, saying that the study was unlikely to meet its efficacy target. The company said it made the decision after a futility analysis indicated that the trial was not likely to succeed, when measured against a standard scale.
Attitudes are indeed changing, but one need remains clear: access to data obtained during clinical and ongoing trials. The feedback suggests that pharma has significant opportunities to get closer to HCPs via more transparency about drugtrials and data. Will they transform their HCP marketing or stick to dated models?
China’s Kintor Pharmaceutical has begun late-stage US clinical development of its potential COVID drug proxalutamide – but there is scepticism over the company’s claims about its research. But Reuters reported that the doctor identified as its principal clinical trial investigator has said he is not in charge of the trial.
And a fragmented clinical trials industry has made it a prime target for private equity, which often consolidates markets by merging companies. To date, 11 of the 25 private equity firms identified by industry tracker PitchBook as the top investors in health care have bought stakes in clinical research companies.
BioPharma Dive interviewed our Derek Ansel on how to conduct psychedelic clinical research. In April 2022, the Food and Drug Administration (FDA) issued draft guidance on developing a “Race and Ethnicity Diversity Plan” for clinical trials. But in rare disease trials, that can be challenging given the barriers inherent in U.S.
Researchers at the University of Oxford in the UK have started a trial of TNF inhibitor adalimumab for COVID-19 patients in care homes and other community settings. Sandoz is providing the adalimumab to be used in the trial, which will be carried out at care homes around the UK and is due to get underway later this month.
Unlike commercial pharmaceutical packaging, the primary consideration in clinical trial packaging is protecting the product quality and reliability for research. Finding the best clinical trial packaging services providers. Clinical trial packaging and labelling solutions.
Lack of access, strict regulations, and demanding schedules have made it extremely difficult for patients to participate in clinical trials. A 2018 NIH survey found that patients felt clinical trial participation to be inconvenient and burdensome, and nearly half (49.0%) said it disrupted their daily routine.
based aTyr Pharma has finalized enrollment for a phase 2 trial to evaluate an investigational anti-inflammatory drug in COVID-19 patients with severe respiratory complications. The double-blind, placebo-controlled trial, which has 32 participants across the U.S., San Diego, Calif.-based Source link.
Diverse clinical trials are a matter of equity and essential for the validity and reliability of research outcomes. Historically, racial and ethnically minoritized groups or populations have been excluded from clinical trials, leading to a lack of data on how different demographic subgroups respond to treatments.
Scottsdale, AZ (May 26, 2020) – VirTrial today announced a new service designed to enable virtual site monitoring visits in the clinical trials industry. The solution enables pharmaceutical sponsors and CROs to evaluate, qualify and routinely monitor research sites for studies without physical travel.
Analysing real-world health data could help overcome the bias towards men in traditional medical research, says Sensyne Health’s Dr Lucy Mackillop. Medical research has often focused on men, meaning that the insights gained have not always been reflective of how women would react to a treatment or disease.
The need for diversity in clinical trial populations has been a topic of discussion across regulators and the industry in general for decades. Fundamental barriers and deeply rooted mistrust of medical research motives among communities of colour require a more thoughtful and deliberate approach to participant outreach.
Clinical trials are studies involving human volunteers to research ways to prevent, detect, and treat various medical conditions. The goal is to identify safer, more effective methods of treating illnesses using new drugs or new combinations of existing drugs.
One of the common research approaches to treating brain diseases such as Parkinson’s disease (PD) and Alzheimer’s disease (AD) is using antibodies designed to clear the accumulated misfolded proteins implicated in the diseases. To date, these drugtrials have not been particularly successful at i.
Drug Industry Daily (DID) the premier online resource for savvy pharmaceutical professionals whose jobs depend on accurate knowledge about the daily activities of Congress, the FDA, other key regulators … and what their competitors are up to.
As people have become more conscious and vocal about diversity and inclusion, Page & Page’s Lisa Lishman says pharma should reassess how it conducts clinical trials. The pharmaceutical industry is one of the most important industries in the world, providing lifesaving drugs and treatment to people who need it the most.
The FDA has issued a clinical hold on Bellicum Pharmaceuticals for its ongoing phase 1/2 trial evaluating CAR-T therapy BPX-601 in patients who received prior treatment for metastatic pancreatic or prostate cancer, following the death of a trial participant. The Houston, Tex., The Houston, Tex., Source link.
There has been increasing awareness around the need for improving inclusion and diversity in clinical trials. And Black people continue to face generational disenfranchisement in healthcare systems and medical research. Despite these statistics, in the US, Black people only constitute five percent of all clinical trial participants.
Cardiovascular clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different race and ethnicity. The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. In the same webinar, Dr. Hansie M.
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