Run-in period
Encyclopedia
Run-in period is a period before a clinical trial
is commenced when no treatment is given. The clinical data from this stage of a trial are only occasionally of value but can serve a valuable role in screening
out ineligible or non-compliant participants, in ensuring that participants are in a stable condition, and in providing baseline observations. A run-in period is sometimes called a washout period if treatments that participants were using before entering the clinical trial are discontinued.
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...
is commenced when no treatment is given. The clinical data from this stage of a trial are only occasionally of value but can serve a valuable role in screening
Screening (medicine)
Screening, in medicine, is a strategy used in a population to detect a disease in individuals without signs or symptoms of that disease. Unlike what generally happens in medicine, screening tests are performed on persons without any clinical sign of disease....
out ineligible or non-compliant participants, in ensuring that participants are in a stable condition, and in providing baseline observations. A run-in period is sometimes called a washout period if treatments that participants were using before entering the clinical trial are discontinued.
See also
- Randomized controlled trialRandomized controlled trialA randomized controlled trial is a type of scientific experiment - a form of clinical trial - most commonly used in testing the safety and efficacy or effectiveness of healthcare services or health technologies A randomized controlled trial (RCT) is a type of scientific experiment - a form of...
- Regulatory requirementRegulatory requirementRegulatory requirements are part of the process of drug discovery and drug development. Regulatory requirements describe what is necessary for a new drug to be approved for marketing in any particular country. In the US, it is the function of the Food and Drug Administration to establish these...
- Safety monitoringSafety monitoringSafety monitoring of a clinical trial is conducted by an independent physician with relevant expertise. This is accomplished by review of adverse event, immediately after they occur, with timely follow-up through resolution....
- Serious adverse eventSerious adverse eventA serious adverse event in human drug trials are defined as any untowardmedical occurrence that at any dose#results in death,#is life-threatening#requires inpatient hospitalization or prolongation of existing hospitalization...
- Standard Operating Procedures
- Standard treatmentStandard treatmentStandard 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...
- Study population
- Data ManagementData managementData management comprises all the disciplines related to managing data as a valuable resource.- Overview :The official definition provided by DAMA International, the professional organization for those in the data management profession, is: "Data Resource Management is the development and execution...