Background: Randomized controlled trials are the gold standard for clinical research. Biostatisticians are heavily involved in such trials, from the planning stage (e.g., sample size and power considerations) through the analysis of findings (e.g., estimation of treatment effects). In this assignment, we will examine treatment outcomes in a two treatment, two period (two-by-two) crossover design.
In the two-by-two crossover design, subjects are randomly assigned to one of two groups. The first group initially receives treatment A in the first period of the trial followed by treatment B in the second period of the trial, and the other group initially receives treatment B in the first period of the trial followed by treatment A in the second period. The response, or primary endpoint of the trial, is measured at least twice in each patient, at the end of the first period and again at the end of the second period. Each patient is his or her own control for comparison of treatment A and treatment B.
Crossover designs are used when the treatments alleviate a condition, rather than effect a cure. After the response to the treatment administered in the first period is measured, there is a washout period in which any lingering effect of the treatment administered in the first period dissipates, and then the response to the second treatment is measured.
An advantage of a crossover design is increased precision afforded by comparison of both treatments on the same subject, compared to a parallel group clinical trial (in which patients are randomized onto different treatment arms). Disadvantages of crossover trials are complex statistical analyses of findings (typically, by complex analyses of variance), potential difficulties in separating the treatment effects from the time effect (patients may respond differently in the first period and the second period), and the carryover effect (the effect of the treatment given in the first period may not totally wash out, but may carry over onto the second period).
We will give a simple example of a two-by-two crossover trial, and undertake analyses of the trial results via t tests. The trial was meant to assess the efficacy of a new experimental therapy for interstitial cystitis (IC). Interstitial cystitis is a chronic bladder condition affecting primarily women; symptoms include bladder pressure and pain, urgency, and occasionally pelvic pain. The new experimental therapy was meant to reduce pain and urgency relative to standard therapy. A total of 24 patients were enrolled in the trial; trial results are given in the Excel workbook titled MHA610_Week 4_Assignment_Crossover_Trial_Data.xls.
Open the workbook, and examine the worksheet. The first row contains column headings, and the next 24 rows represent the 24 patients entered into the trial. The group one patients received experimental therapy in the first period of the trial followed by standard therapy in the second period of the trial. The group two patients received standard therapy in the first period of the trial followed by experimental therapy in the second period.
The primary outcome of the trial was an area under the curve (AUC) calculation of relative pain and urgency the patient experienced following therapy: the smaller the AUC, the less severe the patient’s pain and urgency. AUC_period1 denotes each patient’s AUC during the first period of the trial, and AUC_period2 denotes the patient’s AUC during the second period of the trial. The column headed Rx denotes the treatment each patient received during the first period of the trial.
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