Experimental Studies

Experimental studies compare the effect of interventions or treatments with a control. In many cases, a placebo is used as the control, although when comparing a new treatment against the traditional “gold standard”, the gold standard may be used as the control.

Experimental Studies are conducted in four phases:

• Phase I: a small number of healthy volunteers (e.g., 20-80) to determine the safety of a treatment or drug
• Phase II: a target population (75-300) to determine the effect of a treatment method or drug
• Phase III: a larger patient population (1,000-2,000) to determine if the new drug is better than the standard
• Phase IV: also known as clinical trials, these are conducted on patients in daily life

Experimental studies, especially those in phase III, typically utilize randomized control trials (RCTs) to determine if the new drug or treatment is safe, effective, and has better and/or fewer adverse effects than the standard treatment.

Other types of studies utilized in experimental studies include crossover studies and self-controlled studies.