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.
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.
Considerations for Feasibility for Translational Research
For many researchers, considering the feasibility of a translational study with Sanguine Biosciences is a crucial yet challenging step. The proposed study they submit might not be possible based on real-world evidence or Sanguine’s service offerings, requiring them to modify their criteria.
The global search for a treatment targeting the novel coronavirus has led to an unlikely potential savior: a cocoa-colored llama named Winter, whose blood could hold a weapon to blunt the virus.
She lives at a research farm in Belgium with about 130 other llamas and alpacas.
