2021 marks 14 years of growth for STATinMED Research. We celebrate our progress with a new brand and company website! Brand Renewal The power of a brand is more than meets the eye. Certainly, the logo and other visual elements are instantly recognizable as the face of...
It was an honor and privilege to be among the speakers at Texas A&M’s Student Conference on National Affairs (SCONA) February 11-12, 2021 discussing “Leadership On the Front Lines.” Among the Speakers were General James McConville, 40th Chief of Staff of the US...
In 2016, the 21st Century Cures Act (Cures Act) directed the Food and Drug Administration (FDA) to accept statistical methods that include Real-World Data (RWD) and Real-World Evidence (RWE). The next year, the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) issued guidance regarding the submission of RWD and RWE to the FDA.
Designated, "Long COVID", there is significant concern over the potential long-term effects among COVID-19 survivors. The most prominent end-organ systems at risk for long-term effects are pulmonary, cardiovascular, and central nervous system (CNS). The CNS effects can result either from primary involvement by COVID, like hyposmia, or risk from secondary morbidity, such as hypercoagulability causing a stroke.
Before a medicine can be prescribed to a patient, clinical trials must be conducted, and study outcomes scrutinized by the United States (US) Food & Drug Administration (FDA). While this FDA approval allows a medication to be prescribed to a patient, public and private health insurance payers (payers) then decide whether the medication will be reimbursed.
Physicians in practice and their patients create real-world evidence. Through guidelines-based care and clinical judgment, physicians and advanced care providers prescribe diagnostic studies and therapies that constitute it. Every type of healthcare setting from tertiary care, and National Cancer Institute-designated comprehensive cancer centers, to community clinics is included.
To impact clinical practice, it is important to select a medical journal with a large circulation and readership directly involved in decision-making of the care that was studied. Many sources provide metrics for journal selection, which help guide priorities based on the resulting value message and target audience.