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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.
This is vital if we’re to ensure that drugtrials are inclusive and deliver results that are representative of the entire population. Historically, clinical trial sites have been concentrated in urban centers or tied to academic institutions. For independent clinical trial sites, this is currently unattainable.
Clinical trials, however, don’t reflect that diversity. A study published in JAMA Oncology found that in cancer drugtrials conducted between 2008 and 2018, nearly two-thirds of participants were non-Hispanic whites. When trial populations don’t match the broader patient base, the treatments they produce aren’t as effective.
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. Developing an efficacious vaccine against malaria has been a huge challenge.
RELATED: New Report Highlights Major Barriers to IPF Disease Management Clinical trials for pulmonary fibrosis play a crucial role in advancing our understanding of the disease and developing new treatment options. They aim to improve patient outcomes, slow disease progression and enhance quality of life.
That is part of the responsibility of the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER). Department for Health and Human Services (DHHS), prepared guidance on expedited programs for sponsors of orphan drugtrials. These centers, in conjunction with the FDA and U.S.
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.
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. In January 2015, the FDA implemented its DrugTrials Snapshots program to make clinical trial demographic data more transparent and available.
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.
Takeda has forecasted continued financial pressure but is banking on new drugtrials to stabilize its position. This includes 495 people at its Cambridge, Massachusetts headquarters and 146 at its Lexington campus in the same state.
Staying on top of evolving regulatory requirements for a complex medical device category can be overwhelming, even for well-established lifescience companies. How do you determine if clinical trials are needed for your device? Think of the intent or purpose for the intended use (e.g.,
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