Registration for a large-scale randomized controlled trial of postsurgical adjuvant chemotherapy for lung cancer in Japan

Abstract

Background. The reliability of results obtained from clinical trials depends on the study design and its implementation, but there are few reports on implementation. We aimed to describe one component of implementation, registration problems, as observed in a large-scale randomized trial of postsurgical adjuvant chemotherapy for lung cancer whose subjects were enrolled during the period from 1994 to 1997.

Methods. The trial adopted central registration through telephone or facsimile entry at a randomization center. Unexpected entry processes were counted prospectively, with the reason noted. The time from the start of speaking on the telephone to entry completion was measured automatically by a computer system.

Results. The office registered 999 of 1054 patient reports after checking eligibility criteria. Reasons for failure to meet the criteria were: age (22 patients), late entry – more than 6 weeks after surgery (10 patients), histology (8 patients), entry from hospitals for which the contract for trial participation had not been completed (5 patients), and other (10 patients). Among the 999 registered cases (807 telephone entries and 192 facsimile entries), 50 cases (5.0%) showed a lack of information on eligibility criteria on the first call: 17 made by telephone (2.1%) and 33 by facsimile (17.2%). The average time for registration by telephone was 2 min 51 s among the 766 registrations completed without problems on the first call. The busiest hours for the entry calls were 9:00 to 10:00 and 15:30 to 17:00. There was no difference in the number of entry calls among the days from Monday to Friday.

Conclusion. Actual registration of a large-scale cancer trial in Japan was documented, which provided useful information for both the trial centers and the doctors engaging in clinical trials.