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The drug is the first FDA approved oral suspension form of zonisamide. Hear about how the drug could help increase accessibility and flexibility for epilepsy patients and improve treatment adherence. Subscribe to the Xtalks LifeScience Podcast to never miss a new episode.
To ease this burden, the lifesciences industry has been searching for ways to make clinical trials more accessible for patients and to drive participation numbers, increase participant diversity, and improve overall patient experience. Build a base in the community. Keep it simple. In fact, the opposite is true.
For a clinical trials organization to achieve this level of scale is notable. The clinical trials sector in the US is typically made up of small independent businesses that collectively play an important role in trialing new protocols and aiding drug development. Velocity is among the few exceptions.
Disease doesn’t discriminate, and researchers understand different populations react differently to drugs. Why, then, are clinical trials so stubbornly homogeneous? Clinical trials, however, don’t reflect that diversity. Why aren’t clinical trials more inclusive? Nearly all diseases have a genetic component.
Orphan drugs have historically faced a number of barriers, such as limited research and development (R&D) investment due to an expected lack of profitability as well as challenges in clinical trial design and recruitment. Before 1983, only 38 orphan drugs had received U.S. Food and Drug Administration (FDA) approval.
They aim to improve patient outcomes, slow disease progression and enhance quality of life. Here’s an overview of clinical trials for pulmonary fibrosis: Drugtrials: These trials may involve investigational drugs targeting specific pathways involved in fibrosis or assessing the efficacy of approved drugs in combination therapy.
Related: After 18 Years, FDA Approves Malaria Prevention Drug. Given the success of Oxford’s Phase II trial, the study investigators are now gearing up for a Phase III licensure trial to assess large-scale safety and efficacy in 4,800 children aged 5 to 36 months across four countries in Africa.
Their findings: 60 percent of trials included exclusion criteria that could disproportionately apply to these minority participants. This analysis was based on the identification of over 2,700 individual exclusion criteria that the research team organized into 56 categories.
(CDS), a leading technology provider focused on data collection and clinical trial management, today announced several updates in celebration of its tenth anniversary, including the company’s latest technological development, TrialKit AI, a machine-learning API.
The US Food and Drug Administration (FDA) is emphasizing the need for diversity in clinical trials. This started back in 1993 when the FDA established guidelines to increase diversity by gender and race/ethnicity of participants in clinical trials that were contributing to new drug approvals. or greater than 1.2
A significant initiative is the Diversity Convergence project, which brings together multiple organizations, including the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard, FasterCures, a center of the Milken Institute and the National Academies’ Forum on Drug Discovery, Development and Translation.
Despite these statistics, in the US, Black people only constitute five percent of all clinical trial participants. The overwhelming majority of trial participants nationwide are white. Educating potential Black trial participants about different trial models could help encourage greater participation.
Takeda has forecasted continued financial pressure but is banking on new drugtrials to stabilize its position. With fewer sales from blockbuster drugs, these companies need to streamline. This includes 495 people at its Cambridge, Massachusetts headquarters and 146 at its Lexington campus in the same state.
While drugs require Phase I-III clinical trials—and are also subject to post-approval tracking—digital therapeutics, devices, and IVDs may be able to leverage bench testing, animal studies, pilot studies, and training sets. Interpreting evolving regulations for these devices is often a unique challenge for emerging biotech companies.
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