In Japan,either almost people don't know about clinical trial,or if they do know, they have a bad image of them.For this reason,it can be hard to obtain informed consent. Therefore,we are making efforts to help patients learn about clinical trial and Clinical Research Coordinators(CRCs).

We introduce our activities which we help patients create a better understanding and patient recruitment by CRCs.We also evaluated the result of patient recruitment for a year since August 2003.

◆The booklet entitled "Medicine and Clinical Trials"
◆The booklet entitled "Clinical Trial News"

◆Plasma displays
◆Homepage
◆Poster

We have displayed
the booklets on the rack.

Each addresses these frequently questions :

"What are clinical trials?"
"What is a CRC?"
"What is informed consent?"

Poster

Homepage

Clinical Trial News

Plasma displays are connected with the computer by LAN.

First of all, CRCs list up the appointment of outpatients, and then check the age, medicines,complications of outpatients.
CRCs check clinicat trial criteria.
Finally, CRCs asked the investigators the check whether we can enroll the recruitment patient.
Evaluation criteria
◆The number of patients whom CRCs recruited.
◆The number of patients whom CRCs listed up.
◆The number of patients whom we obtained informed consent.
◆The number of enrollment patients after CRCs recruit.
◆Total of enrollment patients in each clinical trial.
We evaluated whether CRCs contributed the enrollment.

Under our activities,we have many calls or visits of patients who want to participate the clinical trial.Since CRCs started recruiting, patient enrolled the clinical trial which no one enrolled till then. We understand that the recruit by CRCs is not efficient. But the rate of obtaining informed consent of patients to whom CRCs recruited was high.
In protocol A and B, the period from the protocol start to the first enrollment were 4months,19months, and both of the first enrollment were the patients which CRCs recruited.

In protocol D,when it started, CRCs and the investigator were talking about the recruitment at the start up meeting. The investigator recruited the patients from the beginning,so the first enrollment was speedy. In protocol C, it was for the orphan drug. The investigator asked CRCs the recruitment, but CRCs checked severely and the number of patients whom CRCs listed up was zero.As CRCs sometimes made contact with the investigator about the list of the patients,recruitment by the investigator increased.

We think that patient recruitment by CRCs contributed to the increase of the enrollment. Furthermore,
CRCs should promote recruitment and enrollment in clinical trials with the investigators and all staffs of our hospital.