Role of clinical research coordinators in promoting clinical trials of drugs for surgical patients.
BACKGROUND
Clinical trials play a central role in the establishment of clinical evidence, and the important role of clinical research coordinators (CRCs) in various processes of clinical trials is now widely recognized. In Japan, many CRCs work under the discretion of their hospital and support clinical trials in various areas. Modification of CRC activity pursuant to the types of clinical trials may make roles of the CRC more effective and meaningful. In the present study, we examine the dedicated role of the CRC considering the specialty of a registration trial of a drug for surgical patients used during the operation period.


METHODS
In 2006, we had a chance to support a registration trial of a drug for surgical patients used during the operation period. Regarding the mental and emotional status of possible participants in the present registration trial, we collected data from the perspective of CRCs by focus group interviews involving four CRCs working under the discretion of Tokushima University Hospital. The four CRCs were all nurses and had 7, 4.5, 1, or 0.5 years experience as CRCs, respectively.


RESULTS
In contrast to clinical trials of drugs for chronic diseases, these often anxious patients must decide whether or not to enter the trial simultaneously with the decision to undergo surgery itself, and all in a relatively limited time after receiving explanation of the trial. Therefore, special attention should be paid to the mental and emotional status of possible participants. Additionally, the cooperation of the relatively large surgical and nursing staff becomes important. In such situations, the following contributions of CRCs were considered to be useful for the harmonious procedure of clinical trials: 1) providing a precise explanation of the trial to the participant and key persons, 2) understanding the needs of the investigators and appropriately assigning themselves roles, and 3) communicating between the investigators and surgical and nursing staff.


CONCLUSIONS
Further study is warranted to evaluate the benefit of the intervention provided by dedicated CRCs in running high quality clinical trials involving surgical patients.
Yanagawa
Hiroaki
H
Clinical Trial Center for Developmental Therapeutics, Tokushima University Hospital, Tokushima, Japan. niseko@clin.med.tokushima-u.ac.jp.
Akaishi
Akiyo
A
Miyamoto
Toshiko
T
Takai
Shigemi
S
Nakanishi
Rika
R
Irahara
Minoru
M