WIKIMEDIA, FRIBBIWhat’s known as translational research can be divided into two stages. The first stage—“from bench to bedside”—aims to validate the effectiveness of a drug or biotechnology in the clinic. The second aims to validate the efficacy and safety of the clinical application of the technology in everyday medicine. The U.S. Food and Drug Administration’s role in this process is to ensure the safe and ethical transformation of new drugs and biotechnologies into human clinical trials, and thereafter, into clinical practice.
As we reflect on the 30-plus years since the FDA approved human insulin created through the insertion of human DNA into E. coli, it is appropriate to reflect on whether the agency’s regulatory abilities have kept pace with the changing research landscape. It is also important to consider whether scientists and researchers clearly understand when it is ethical to move from testing a scientific concept in a Petri dish, to testing it in humans, and translating the technology into medical care. There are three major shifts or questions in the medical research landscape that may be obfuscating this process.
One shift is the increasing presence and role of biotechnology in medicine. Historically, medicines were derived largely from natural sources and well-known chemical compounds. Today, however, ...
