EFFICIENCY OF INVESTIGATORS IN RECRUITMEN T OF PATIENTS FOR CLINICAL-TRIALS - A CASE-REPORT OF A MULTINATIONAL STUDY

BACKGROUND: Performance and efficiency in patient selection are essent ial for conducting clinical trials. Data on these are presented from a multinational trial. PATIENTS AND METHODS: A randomized, double-blind , placebo-controlled, parallel-group study in asthma, with a screening phase followed after randomization by a treatment period, was selecte d. Number of patients screened and randomized by centre and country, c entres achieving the minimum recruitment (greater than or equal to 10 patients randomized), and efficiency of investigators (randomized/scre ened x 100) were determined and compared. RESULTS: 564 patients, out o f 836 screened, were randomized at 69 centres in 11 countries. Twenty- four centres (35%) randomized greater than or equal to 10 patients eac h, accounting for 70% (n = 395) of the total number recruited, Efficie ncy was significantly higher among these ''high-performance'' centres (81.4%; p < 0.001; OR, 4.7; CI 95%, 3.4-6.5) than in the remaining one s (48.1%). Five countries had greater than or equal to 2 ''high-perfor mance'' centres. Efficiency was also significantly higher (p < 0.001) among those (370 randomized/455 screened, 82,1%) than in the remaining centres of the same countries (82/140; 58.6%; OR, 3.0; CI 95%, 2.7-4. 7). A relevant number of centres (n = 17; 25%) randomized 0-1 patient (7 randomized/58 screened). CONCLUSION: The analysis of patient select ion in clinical trials showed that a minority of centres accounted for most of the patients recruited. Those are not only the most productiv e (more patients randomized) but also the more efficient (better quali ty of screening process).