Access to samples is essential to researchers’ experiments and assays. This is important when researchers are developing a proof of concept and they need a small set of samples, but it’s also important throughout the duration of studies. At the beginning of their studies, access to data allows researchers to “get their feet” wet and assess their ability to produce real-world data.
We at Sanguine Bioscience have partnered with multiple biotech and pharmaceutical companies, such as Vir Biotechnology and EpiVax, Inc, to facilitate over 23 research studies aimed at gaining a better understanding of COVID-19. Although the overarching goal of this research is to develop treatments and vaccines, valuable information can be obtained about the virus, its patterns of infection, and the effectiveness of community response to the epidemic.
Longitudinal studies are powerful tools in medical research armamentarium. Researchers gain valuable information following the same group of people with repeated measured variables over time. This type of research provides rates of change of continuous variable(s) over weeks, months, or years allowing researchers to assess patterns in human behavior or cause and effect relationships.
Research on the human microbiome has burgeoned in recent years. Microbiome imbalances have been linked to chronic conditions, such as diabetes, cardiovascular disease, and depression. But scientists have also uncovered evidence of the microbiome’s crucial role in infectious diseases, including COVID-19, pointing to it as a promising target for treating them.
Historically, medical research data obtained from other sources outside of traditional clinical trials were viewed with a heavy dose of skepticism even before evaluation of the methodology. Although this real-world data (RWD) was widely used to satisfy safety monitoring and post-drug approval regulation requirements, many clinicians viewed RWD and the real-world evidence (RWE) it generated as unverified and unreliable data mining explorations with drug marketing objectives.
Hemolysis is the rupture of red blood cells, and it has multiple causes, can happen at any time, both in vivo and in vitro. Hemolysis Can Endanger Your Results Hemolysis can certainly impact study results, and has a particularly well-documented impact on potassium concentration measurements.
The Benefits and Challenges of Real-World Data to Support Traditional Clinical Trial Initiatives Historically, medical research data obtained from other sources outside of traditional clinical trials were viewed with a heavy dose of skepticism even before evaluation of the methodology. Although this real-world data (RWD) was widely used to satisfy safety monitoring and post-drug approval regulation requirements, many clinicians viewed RWD and the real-world evidence (RWE) it generated as unverified and unreliable data mining explorations with drug marketing objectives.
Study-patient recruitment and retention continue to be significant challenges in medical research. According to a Tufts Center for the Study of Drug Development report, 48% of study sites miss their enrollment targets, and 11% fail to enroll a single patient. This results in the need for study sponsors to nearly double study timelines to meet recruitment goals.
The coronavirus pandemic has altered virtually every aspect of life. Pharmaceutical research, specifically clinical trials, are no exception. To slow the virus’ spread, the Centers for Disease Control and Prevention has recommended social distancing — essentially, avoiding close contact with others.
The at-home isolation and social distancing orders for millions of Americans is a vital element to slow to the COVID-19 pandemic. With most of our daily activities on-hold or modified for the foreseeable future, medical research is a crucial pursuit that continues despite the current environment.