Standard treatment
Encyclopedia
Standard treatment. 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 the clinical 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.
s are usually double-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 .
Clinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
, 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 trialClinical trial
Clinical trials are a set of procedures in medical research and drug development that are conducted to allow safety and efficacy data to be collected for health interventions...
s are usually double-blind
Double-blind
A blind or blinded experiment is a scientific experiment where some of the people involved are prevented from knowing certain information that might lead to conscious or subconscious bias on their part, invalidating the results....
, 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 .
See also
- Drug developmentDrug developmentDrug development is a blanket term used to define the process of bringing a new drug to the market once a lead compound has been identified through the process of drug discovery...
- New drug applicationNew drug applicationThe New Drug Application is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration approve a new pharmaceutical for sale and marketing...
- U.S. Food and Drug Administration (FDA)
- European Medicines AgencyEuropean Medicines AgencyThe European Medicines Agency is a European agency for the evaluation of medicinal products. From 1995 to 2004, the European Medicines Agency was known as European Agency for the Evaluation of Medicinal Products.Roughly parallel to the U.S...
- International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
External links
- ClinicalTrials.gov from US National Library of Medicine
- ICH Website
- FDA Website
- Clinical Research Training
- Careers in Clinical Research
- Clinical Research Services
- Clinical Research Companies Listings
- International Clinical Research Services and Corporate Trainings
- Clinical Research Abbreviations and Acronyms
- Clinical Research Glossary / Definitions
- List of Food and Drugs Regulatory Agencies
- Clinical Research: Frequently asked questions