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9.5`9.9 2004 in New Orleans
Activites on the development and the prevalence of clinical research trials at National Center for Global Health and Medicine.
Hiroyoshi Kato, Mari Shirotani, Naoki Kondo, Atsushi Kubota, Yoshihiko Suzuki, Nobutsugu Yoshino, Osamu Okazaki, Naomi Uemura
Clinical Trial Management Office, National Center for Global Health and Medicine,Japan
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Background

Since 1997, the new version of GCP (Good Clinical Practice) has been carried out in Japan for the purpose of clinical trials with the high quality data which can share with the Western countries. In 1999, we established the clinical trials management office and started the activity of CRC (Clinical Research Coordinator) in our hospital for the efficacy of clinical trials.
As first activity of CRC, we had to try to educate and spread of clinical trials to patients, because patients had little understanding of them and that was big obstacle to advance clinical trials.
In the goverment, pharmaceutical companies and medical institutions, various activities for education to clinical trials have been performed.
And the result of them have begun appear, in imcj from 1999 to 2004, 107 clinical trials have been contracted and about 500 patients have participated in clinical trials. (Fig.1) Also IRB and EC have been held in every month.

Aims

We report efficiency that we have performed activities for education of clinical trials in imcj.

Results

Activities for education of clinical trials

₯A pamphlet "From the clinical experiment to the medicine" was published in 1999.
₯A booklet "clinical trials news" has been publishese twice a year since 2001.
₯A homepage on the web-site has been in 2000.
₯The on-line information of clinical trials using plasma display has been started for outpatients since 2002.
₯The poster of recruitment of clinical trials has been stuck on the wall of a
consultation room since 2002.

₯The enrollment of clinical traial in imcj (1999-2004)
The enrollment of clinical traial in imcj (1999`2004)

₯(fig.1) The number of the new clinical trials contracted in imcj (1999-2004)
(fig.1) The number of the new clinical trials contracted in imcj (1999`2004)

₯The enrollment of clinical traial in imcj (1999-2004)
The enrollment of clinical traial in imcj (1999`2004)



1. A pamphlet "From the clinical experiment to the medicine"

As the beginning of this activity, we made it as supplemental material of informed consent.
Because all most patients did not know clinical trials. We use it when we explain clinical trial to patients and put on the bookstand in lobby to be read by many patients since 1999.

clinical trial newsItems of the pamphlet.
"The necessity for development of the medicine"
"The process of development of the medicine"
"The clinical trials for development of the medicine"
"The rule for carrying out the clinical trial"
"Three steps in clinical trials, phase I ,II ,III"
"The necessity for a placebo in the clinical trials"

The contents are very easy with some illustrations!!



2. A booklet "clinical trial news"

We have published a booklet "clinical trial news", twice a years in order to let more patients understand clinical trials and our activities and put them on the bookrack in lobby.
Many patients have read them in our hospital or their home.

₯The booklet entitled "Clinical Trial News"

clinical trial The booklet entitled "Clinical Trial News"


3. The homepage

web site Our homepage has been created in 1999.
The internet made it possible to get much information at anytime and anywhere to us.
In the world, many people use the internet. Therefore, the homepage is an important messages for many people to understand clinical trials.
Our homepage is very useful for patients,
pharmaceutical companies and people who do not know clinical trials.



4. Plasma display
Plasma display Plasma display
Plasma display Plasma display Plasma display Plasma display
Plasma display Plasma display Plasma display
Plasma display Plasma display

The on-line information of clinical trials using plasma display has been started for outpatients since 2001.
Four plasma displays are set up in the outpatient lobby and the entrance of inpatient building. From 8:30 to 17:00, we give information service of clinical trials to outpatients and inpatients while wating for consultation.
LAN connects with the computer of our office to control.
The feature of plasuma display is that
1. A screen attracts peoples attention.
2. A lot of information can be given for the short time.
3. Update can be carried out timely and easily.
This informstion service is very popular with patients and it is used as other section information service in a hospital,too.



5. The poster for recuruitment

The poster for recruitment of clinical trials participation has been stuck on the wall of a consultation room since 2002.
It is made for each clinical trials. After recognized by IRB, it is put up in a lobby and consultation rooms. The subject of disease, criterias for enrollment, name of investigators, are written in the poster and the plasma display.
The poster is very useful to give publicity to clinical trials being carried out.

poster


Result and Discussion

Our job has had good efficiency to enroll patients in clinical trials. An understanding about a clinical trials is spreading steadily in imcj.
For example, when we explain clinical trials, almost patients say that I looked at Plasma display and I know clinical trials.

Some patients looked at poster and visited to our office to participate in the clinical trial. Some patients looked at our homepage and called to our office about clinical trial that are carried out now. Some patients said that they would like to get all numbers of booklet of clinical trial news. I would like to emphasize that they are very wonderful facts.



Conclusion

In imcj, 5 pharmacist, 3 nurses, and a clinical technologist are working as CRC.
Their duty is ensuring of subject's safety and securing the reliable data.
In Japan, many pharmacists are working as CRC to create good the medicine.
It is expecting that the consciousness of creating the medicine and bringing medicine has been understood by such our activities.








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