Stan Woolen worked for FDA’s Office of Enforcement in the 1990’s, where he was tasked with a great deal of public speaking shortly after he became the Agency Bioresearch Monitoring (BIMO) Program Coordinator. He had years of experience on the ground with GCP and GLP, but found himself in need of shortcuts for helping him organize the tremendous amount of public speaking in front of him. His personal shortcut for tenets of data quality was ALCOA, but when he ran out of space on a slide one day, he included the acronym. After that, it stuck.
THE FUTURE OF CLINICAL RESEARCH: THE CHANGE IN THE AIR.
Some dread it.
Others create it.
Either way, you know it is inevitable.
The clinical research industry is no exception. Ever since James Lind’s famous scurvy trial in 1747,1 where he demonstrated the affliction could be cured by the consumption of oranges and lemons, the concepts, tenets, and processes of modern clinical research have been evolving. This is no different today, with the global clinical trials market estimated to grow 7.5% annually to approximately $22 billion USD by the year 2021. Of that, medical device clinical trials are expected to contribute about a third, making transformation of the industry unavoidable.
Global politics, shifting regulations, and technological innovations–all big picture drivers of change– influence not only manufacturers of medicines and medical devices, but the consumers of these products as well. Economic factors affect markets, which drive changes to industry directly and indirectly via changes in regulations. Improvements in technology provide an impetus for changes to processes and efficiency.
These are our top predictions of what is in store for the clinical research industry.
This is the second in a series of articles about medical ethics. In our last post, we reviewed the basics of medical ethics.
Regardless of what holidays you celebrate this season, we here at Hart Clinical Consultants would like to wish you joy, peace, and love during this last month of 2016 and on into 2017.
This is the first in a series of articles about medical ethics. Medical ethics is a sub-category of bioethics, which also includes animal ethics and environmental ethics, according to the Internet Encyclopedia of Philosophy.
Join us as we recognize American Diabetes Month this November. This year, the campaign aims to raise awareness about the 29 million Americans with diabetes and to create a sense of urgency about this growing public health crisis. Approximately 1.4 million Americans over 20 are diagnosed with diabetes every year. It remains the 7th leading cause of death, with 69,071 deaths caused by diabetes and 234,051 death certificates with diabetes listed as a contributing cause of death. The disease costs the Unites States approximately $245 billion. For more diabetes statistics, go here.
Welcome back to the Hart GCP knowledge series. Today, we will dive into the definition of essential documents found in the Good Clinical Practice (GCP) guidelines.
Whether you are looking for a new job, looking to hire someone, or looking to expand your skills through volunteer work, the people you know, and the people they know, are one of your best assets.
Today’s entry is a follow-up to an earlier post about blinding in clinical studies, which you can see here.