After completing this chapter, the reader will be able to
- List the major legislative acts that led to our current system of drug evaluation, approval, and regulation.
- List the steps in the drug approval process.
- List the components of an investigational new drug application (IND).
- Recognize the difference between a commercial IND, a treatment IND, an emergency use IND, and an individual investigator IND.
- List all of the requirements (as specified by the Office of Human Research Protections [OHRP]) for an institutional review board (IRB).
- Define orphan drug status and list the advantages of classifying a drug as an orphan drug.
- Prepare appropriate reviews of protocols for use by the IRB or other review committees when they evaluate new protocols.
- Describe the type of support that is necessary for clinical research, including (but not limited to):
- Ordering drug supplies for ongoing clinical trials.
- Maintaining drug accountability records as required by the Food and Drug Administration (FDA).
- Preparing drug and protocol data sheets for use by health care personnel in the hospital.
- Preparing pharmacy budgets for sponsored clinical research.
- Aiding investigators in designing and conducting clinical trials in their institution.
- Assisting investigators in initiating and conducting clinical trials (including emergency use INDs).
It is estimated that $802 million is spent to get a new drug product to market in the United States....