Run-in period is a period between the recruitment and randomization
phases of a
clinical trial
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
, when all participants receive the same treatment, which may be active treatment, a
placebo
A placebo ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures.
In general ...
or no treatment at all. The
clinical data from this stage of a trial are only occasionally of value but can serve a valuable role in
screening
Screening may refer to:
* Screening cultures, a type a medical test that is done to find an infection
* Screening (economics), a strategy of combating adverse selection (includes sorting resumes to select employees)
* Screening (environmental), a ...
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
*
Data management
Data management comprises all disciplines related to handling data as a valuable resource.
Concept
The concept of data management arose in the 1980s as technology moved from sequential processing (first punched cards, then magnetic tape) to r ...
*
Randomized controlled trial
A randomized controlled trial (or randomized control trial; RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical te ...
*
Regulatory requirement
*
Safety monitoring
Clinical monitoring is the oversight and administrative efforts that monitor a participant's health and efficacy of the treatment during a clinical trial. Both independent and government-run grant-funding agencies, such as the National Institutes o ...
*
Serious adverse event A serious adverse event (SAE) in human drug trials is defined as any untoward medical occurrence that at any dose
#Results in death
#Is life-threatening
#Requires inpatient hospitalization or causes prolongation of existing hospitalization
#Results ...
*
Standard operating procedures
A standard operating procedure (SOP) is a set of step-by-step instructions compiled by an organization to help workers carry out routine operations. SOPs aim to achieve efficiency, quality output, and uniformity of performance, while reducing misc ...
*
Standard treatment
The standard treatment, also known as the standard of care, is the medical treatment that is normally provided to people with a given condition. In many scientific studies, the control group receives the standard treatment rather than a placebo wh ...
*
Study population
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietar ...
References
{{DEFAULTSORT:Run-In Period
Clinical research