Question

Clinical trials

Suppose a trial is to be designed to compare the survival of two different therapies in the adjuvant treatment of early breast cancer after removal of the breast tumour by surgery.The treatment should start 28 days after surgery . At what time point should the patients be randomized.

(i) Prior to the start of surgery

(ii) At the conclusion of surgery

(iii) 14 days prior to the start of the adjuvant treatment

(iv) Just prior to the start of the adjuvant treatment

(v) It doesn`t matter,all of the above are statistically acceptable

Choose one answer and justify briefly

Answer 1

It doesn`t matter, all of the above methods are statistically acceptable.

The main thing we have to consider is the two treatments (two different therapies) are given to the patients who had breast cancer and it was removed in an operation. These patients are to receive two different therapies. It does not matter when we randomize them, because the operation procedure is the same for all. After surgery or before surgery does not matter. We can do it any time, but prior to giving them treatment ie therapies.

We randomize them any time prior to giving them therapies. The reason is that we have to randomly give these two treatments to the patients so as to remove any bias in the test.