Adaptive methods: when and how should they be used in clinical trials?

Adaptive clinical trial designs are defined as designs that use data cumulated during trial to possibly modify certain aspects without compromising the validity and integrity of the said trial. Compared to more traditional trials, in theory, adaptive designs allow the same information to be generated but in a more efficient manner. The advantages and limits of this type of design together with the weight of the constraints, in particular of a logistic nature, that their use implies, differ depending on whether the trial is exploratory or confirmatory with a view to registration.

Renal tumor size: comparison between computed tomography and surgical measurements.

Objective: We studied the agreement between renal tumor size as assessed on computed tomography (CT) before surgery and that measured during histopathological examination on the radical nephrectomy specimen.

Methods: We retrospectively analyzed the records of 100 consecutive patients treated with radical nephrectomy for a renal tumor. The tumor size was determined in all patients by the largest diameter shown within the month before surgery on contrast-enhanced CT and as measured postoperatively by the pathologist.

Double-blind multicenter study comparing alprostadil alpha-cyclodextrin with moxisylyte chlorhydrate in patients with chronic erectile dysfunction.

Purpose: We compared the efficacy and safety of alprostadil alpha-cyclodextrin and moxisylyte chlorhydrate to induce erections adequate for sexual intercourse in a prospective, randomized, parallel double-blind study in patients with erectile dysfunction.

Materials And Methods: A total of 156 men with erectile dysfunction due to organic, nonorganic and mixed origin was randomized into 2 parallel treatment groups receiving titrations of an individual optimum dose of alprostadil alpha-cyclodextrin or moxisylyte chlorhydrate. Erectile response was measured by the buckling test.

Oral pharmacokinetics of bisoprolol in resting and exercising healthy volunteers.

The effects of exercise on bisoprolol oral pharmacokinetics were studied in eight healthy male volunteers in an open, randomized, three-period, crossover trial. Oral bisoprolol (20 mg) was given either at rest during 24 h or with iterative stress tests before and 2.5, 5, 10, and 24 h after dosing.