Question 3: (2 pts) Draw a clinical trial study design flow using the following

Question

Question 3: (2 pts) Draw a clinical trial study design flow using the following information: TRIAL A is a randomized placebo- and active-controlled, 12-month trial in 3 arms. 800 adult patients with active RA and an inadequate response to MTX were randomized a 3:3:2 ratio to 6 months of 10mg/day Therapy A, 10mg/day Therapy B, or Placebo on a background of MTX, respectively. Assessors, physicians and patients were blinded to the treatment group assignment for 1 year. Treatment with placebo was limited to days 1-197. On day 198, all placebo-treated patients were reallocated to Therapy A. Patients initially randomized to Therapy A or Therapy B continued their treatment. HINTS: Randomization is always counted as Day 1. Day 197 is the 6-month mark (yes, I know it's not 365/2). Use the lecture notes and the examples of clinical trial study design flows to help you!

Explanation / Answer

Clinical Trial Design Flow

Day – 1, the trial starts with active controlled placebo starting with 800 adult patients. They were given active RA and checked for their inadequate response to MTX. This continued till day 197 where therapy A of 10mg/day, 10mg/day of Therapy B and Placebo was given in 3:3:2 ratio.

The Placebo was given to the patients from only days 1 to 197.

On day 198, the placebo treatment was removed and Therapy A was given. The patients who were given Therapy A on Day 1 were shifted to Therapy B.

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