After recovering from Covid-19 in April, Tom Hanks was so chuffed by the prospect of his plasma being used for medical science that he suggested calling the results a “Hank-cine.” He is not alone. Other former patients are equally enthusiastic about donating blood to the research effort.
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.
Study-patient recruitment and retention continue to be significant challenges in medical research, and even more so, during the COVID-19 pandemic. The at-home isolation and social distancing orders for millions of Americans is a vital element to slow the COVID-19 pandemic, but the global pandemic has the potential to disrupt and delay vital research.
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.
In 2000, Malcolm Gladwell’s The Tipping Point became a runaway bestseller by describing the factors that fuel an epidemic, and how the world suddenly becomes a different place as it reaches the inflection point. He discusses epidemics as spreading quickly like a virus, causing people to start behaving differently, triggering contagiousness, whether it applies to fashion trends, the uptake of cell phones, or the spread of disease.
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.
