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Sourcing Outcomes Data

Data sourcing can be challenging. Identifying optimal data sources requires extensive insight into the data landscape relative to specific research needs.  Successful data sourcing will require a balancing act between research priorities and data availability.  A large majority of data collected during patient care are unavailable for research purposes. This can be attributed to a variety of reasons
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Claims Data: Consider the Source

Keisha Maughn, Principal, Vice President, Real-World Evidence (RWE) at STATinMED Research shares her perspective about claims data, patient insights, coverage plans and navigating the data lake. Not all claims datasets are appropriate for every research question. With...

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Selecting the Most Relevant Data

Choosing the right data to answer research questions is important, especially when it comes to developing an external control arm. External comparators or controls (also known as historical controls) have the potential to improve the evaluation of novel experimental agents in clinical trials.
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New Brand, New Website!

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...

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Front Lines in Medicine: Healthcare During COVID-19

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...

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Real-World Experience: Data, Evidence, Control Arms and Outcomes

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.
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Long COVID: Potential Long-Term Neurological Consequences of the COVID-19 Pandemic

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.
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Failure to Reimburse Successful Therapeutics: Opportunity Costs

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.
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On behalf of our study team, I would like to thank you all for your tremendous help on the study. Acceptance by Stroke is a watershed moment for the Real-World Data program. 

— Oncology Global Patient Outcomes Executive, RWE, with global biopharmaceutical company

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