What can go wrong during the preclinical trials to result in this?
Are there any known examples?
As you know, the aim of preclinical work (animal pharmacology/toxicology testing) is to build up sufficient data to help in deciding that it is convincingly safe to proceed with human trials of the drug. It is better to be safe than to be sorry (as the English wisdom says). Clinical trials correspond to the decisive pre-market testing basis for approving a drug. During these trials, this untried novel compound is given to humans and is assessed for its safety & efficiency in treating, preventing, or diagnosing a specific disease or condition. The results of this testing will comprise the single most important factor in the approval or disapproval of a new drug.
Although the purpose of clinical trials is to obtain safety & efficiency data, the prime consideration in these studies is the safety of those involved in the trials so as they are not exposed to unnecessary risks.
Dear Charllott,
Fortunately trials are stopped as soon as some aspects are found or even when they believe their studies can lead to a negative outcomes. Christian gave us briefly several of those motives. He comes from a giant company that has stopped studies which cost them fortunes and time, but for the reasons mentioned they announced the end of some big projects. Their thesis proved wrong, but their decision was not wrong at all in all the cases I know of.
http://www.medicalnewstoday.com/articles/102421.php
http://circoutcomes.ahajournals.org/content/2/3/279.full
http://thechart.blogs.cnn.com/2011/05/26/heart-http://circoutcomes.ahajournals.org/content/2/3/279.fulltrial-with-niacin-treatment-stopped-due-to-risks/
http://www.wsj.com/articles/SB10001424052702304520804576347293171862646
- Badges
- Science topic
- Similar topics
- Chemistry
- Pharmacology
- Pharmaceuticals
- Drugs