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Clinical trials are vital for advancing medical knowledge and improving patient care. However, conducting trials in different regions, such as the European Union (EU) and the United States (US), involves navigating unique regulatory frameworks and cultural factors. In this blog post, we will explore the nuances in the EU and US clinical trial markets, focusing on study design and protocol development, patient recruitment, prescreening, consent, and patient engagement.
Patient registries, sometimes called patient databases, are a useful tool in any clinical trial patient recruitment strategy. They help researchers quickly identify potential study participants who may meet trial eligibility requirements and have raised their hand as interested in participating in research. In addition, they assist with ensuring that the patient pool is representative of the population being studied. With so many registries available, it can be challenging to know which one might work best for your particular study. Here, we discuss some key factors to consider when selecting a patient registry for clinical trial patient recruitment.
Clinical trials play a critical role in developing new treatments and therapies for Parkinson's disease, an age-related degenerative brain condition that causes slowed movements, tremors, balance problems, and more. Parkinson's disease affects more than 10 million people worldwide, and its prevalence is expected to continue to rise as the population ages. However, with some treatment options currently approved and many trials looking for newly diagnosed or treatment-naive patients, recruiting patients for these trials can be quite challenging. Using a variety of different recruitment channels can help reach the right patients, where they are and when they are looking for options. Here are some important factors to consider when selecting different channels for Parkinson's disease clinical trial patient recruitment.
This webinar, hosted by Sano Genetics Partnership Lead Lindsey Wahlstrom-Edwards and featuring representatives from COUCH Health, Lupus Research Alliance, and Acclinate, highlighted the importance of equitable access as well as community and patient engagement in precision medicine. The discussion centered on various user research topics and methods, including how to evaluate user feedback effectively and the importance of understanding user needs.
For clinical trial sponsors, selecting the right Contract Research Organization (CRO) is a critical piece to the successful execution of a clinical trial. CROs can assist with a wide variety of important elements of the research process, including feasibility and study design, executing the protocol, managing data, and providing regulatory support. It’s important to choose a CRO that understands the services you are and are not looking for, and can work towards meeting your study objectives. In this blog, we’ll review some key considerations to take into account when bringing on a CRO, including CRO focus, services offered, and questions to ask.
In this episode of "The Genetics Podcast," host Patrick Short interviews Daniel McArthur, Director of the Centre for Population Genomics at the Garvan Institute of Medical Research and the Murdoch Children's Research Institute. The discussion focused on the impact of large-scale genetic datasets on patient diagnosis and treating genetic subtypes of disease, and the power of big data and consortiums to enable pioneering discoveries.
Sano Genetics and BenevolentAI have successfully completed the first phase of their research collaboration.
Sano and BenevolentAI have worked closely over the past year to generate a linked genetic and medical record dataset for patients with ulcerative colitis (UC). The project, partly funded by the UK government’s innovation agency grant, uses a study design that doesn’t require patients to travel to specific clinical sites, thus placing them at the heart of the process, enabling ‘real-world’ data to be collected, and creating more interactions between patients and researchers.
In a this webinar, Patrick Short, CEO and co-founder of Sano Genetics, and Patti Engel, CEO of Engage Health, discussed how applying a “rare disease mindset” can accelerate and de-risk precision medicine research. The discussion focused on a case study of a precision medicine trial in movement disorders, particularly Parkinson's disease, where they successfully identified patients with rare genetic variants of interest.
Recruiting patients for clinical trials is a crucial component of the drug development process, and a key factor in determining the success or failure of a study. However, finding the right patients is challenging, and many trial sponsors and clinical research organisations (CROs) turn to clinical trial patient recruitment companies and site databases to help identify and enrol suitable candidates. Of course, these resources can be helpful, but for certain types of trials, there are challenges associated with relying on them. In particular, trials looking for patients with particular biomarkers may be too specific to rely on a traditional patient recruitment company or a site database. In this blog, we review these challenges and alternative methods which may address them.
National DNA Day, observed on April 25th, commemorates the discovery of the double helix structure of DNA. It’s an annual, global celebration – and this year, it marks both the 20th anniversary of the Human Genome Project’s completion and the 70th anniversary of the discovery of the DNA double helix. National DNA Day is a day to reflect on the importance of genetics and DNA research in our lives, including the impact it has had on healthcare.