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Welcome to Pritzker | Ruohonen
Pressures on Clinical Trials
Information on Pressures on Clinical Trials
According to Stan Woollen, Associate Director for Bioresearch Monitoring at the Food and Drug Administration (FDA), the pressures on clinical trials have increased in recent years. There are several reasons for this:
- There is increased competition to get the human subjects needed for a clinical trial. Recent deaths during clinical trials at the University of Pennsylvania and Johns Hopkins have made people less willing to participate in human research.
- There is an influx of clinical investigators (researchers) who may not understand all of the federal, state, and other guidelines for clinical trials. These researchers may not be familiar with clinical procedures and have a greater chance of making a mistake.
- The companies sponsoring the clinical trial want the process to go as quickly as possible. Time is money for these companies. They can not market to the public and make a profit until the clinical trials are over.
- There is an increased reliance on contractors to perform some of the processes in clinical trials, resulting in a possible lack of organization and accountability.
- Sometimes the people and organizations involved in the human research during a clinical trial have a conflict of interest, meaning they stand to gain in some way by positive results from the clinical trial. This has caused numerous problems and puts the human subjects at risk.
The legal and medical issues involved in clinical trials are complex. If you or someone you love has been harmed during a clinical trial, you need a lawyer with experience in complex lawsuits. You want a lawyer who immerses himself in a case and learns everything there is to know about it. Fred Pritzker has had 29 years of experience successfully handling complex cases. His excellence and passion for justice have been recognized by his peers with the designation of Super Lawyer. He has also been selected for inclusion in the 2005-2006 edition of The Best Lawyers in America.
Contact Pritzker | Ruohnen & Associates, P.A., by calling us toll-free at 1-888-377-8900, emailing us at info@pritzkerlaw.com, or submitting your situation for review by our legal counsel with our online form. Consultations are free, and your information is kept strictly confidential.
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