- Standard treatment
Standard treatment (Active Control). The treatment that is normally provided to people with a given condition. In many studies, a
control group receives the standard treatment while a treatment group receives the experimental treatment. After theclinical trial , researchers compare the outcomes of the two groups to see if the experimental treatment is better than, as good as or not as beneficial as the standard treatment.Active (Positive) Concurrent Control
In an active control (or positive control) trial, subjects are randomly assigned to the test treatment or to an active control treatment. Such
clinical trial s are usuallydouble-blind , but this is not always possible; many oncology trials, for example, are considered difficult or impossible to blind because of different regimens, different routes of administration, and different toxicities. Active control trials can have two distinct objectives with respect to showing efficacy: (1) to show efficacy of the test treatment by showing it is as good as a known effective treatment or (2) to show efficacy by showing superiority of the test treatment to the active control. They may also be used with the primary objective of comparing the efficacy and/or safety of the two treatments. Whether the purpose of the trial is to show efficacy of the new treatment or to compare two treatments, the question of whether the trial would be capable of distinguishing effective from less effective or ineffective treatments is critical .ee also
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Drug development
*New drug application
*FDA
*European Medicines Agency
*International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use External links
* [http://www.clinicaltrials.gov/ ClinicalTrials.gov] from US
National Library of Medicine
* [http://www.ich.org ICH Website]
* [http://www.fda.gov/ FDA Website]
* [http://www.kriger.com/training/index.htm Clinical Research Training]
* [http://www.biorole.com/ Careers in Clinical Research]
* [http://www.clinqua.com/ Clinical Research Services]
* [http://www.ibpassociation.com Clinical Research Companies Listings]
* [http://www.kriger.com/ International Clinical Research Services and Corporate Trainings]
* [http://www.krctraining.com/ACRONYMS/index.htm Clinical Research Abbreviations and Acronyms]
* [http://www.krctraining.com/CRA%20Definitions/index.htm Clinical Research Glossary / Definitions]
* [http://www.kriger.com/international_modules/index.htm List of Food and Drugs Regulatory Agencies]
* [http://www.krctraining.com/faq/faq.htm Clinical Research: Frequently asked questions]
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