Treating patients with compounds or biological agents that pass the safety-test
- Published
- Accepted
- Subject Areas
- Clinical Trials, Evidence Based Medicine, Health Policy, Public Health
- Keywords
- Clinical trials, Safety test, Multiple compounds
- Copyright
- © 2016 Zhang
- Licence
- This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, reproduction and adaptation in any medium and for any purpose provided that it is properly attributed. For attribution, the original author(s), title, publication source (PeerJ PrePrints) and either DOI or URL of the article must be cited.
- Cite this article
- 2016. Treating patients with compounds or biological agents that pass the safety-test. PeerJ PrePrints 4:e1626v1 https://doi.org/10.7287/peerj.preprints.1626v1
Abstract
There are numerous medical disorders without effective treatments. It is possible that many of un-treatable conditions need more than one compound co-operatively for improvement or cure. Approval of drugs in the U.S. is governed by a rigorous review process by the Food and Drug Administration (FDA) regulation. A sponsor must demonstrate the drug’s safety and efficacy in well controlled clinical trials in the proper patient population for which it is indicated. Development of a new compound entity (NCE) is a very costly and time-consuming process; it takes roughly 15 years and 1.5 billion dollars on average. The high cost of the process makes the development of a new drug with multiple NCEs almost impossible. There are many compounds or biological agents which pass the safety test, but fail in the efficacy test. Those compounds might be critical for treatment of these medical conditions. The author suggests that compounds or biological agents, which pass the safety test, but the fail in efficacy test, should be allowed to use in clinical setting. The safety of those compounds is comparable with any other drugs approved by FDA. Benefits would heavily outweigh risks for patients treated by those compounds. The same principle should also be applied to biological agents, such as vaccines against HIV infection, cancers, etc.
Author Comment
This is a preprint submission to PeerJ Preprints.