In our national center, we developed the Clinical Research Coordinator (CRC) position in 1999 in order to improve the quality and efficiency of clinical trials.
Pharmacists, nurses and clinical technologists are working for CRCs.

We analyzed whether the activities of Pharmacists contributed to the rate of improvement of contract achievement and efficiency on clinical trials. We also talked about the activities of Pharmacists during clinical trials.

1) Managing and dispensing investigational medical products:
Pharmacists manage the inventory and deliver, dispense and return products based on our database.
International Medical Center pharmacists mix some of the injections.

Safekeeping of investigational medical products.

Pharmacists dispense the investigational medical products.

2) Instruction of investigational medical products for patients:

The form and the recipe method of investigational medical products are various.
The pharmacist gives medicational instruction not only for ingested and injected medicines, but also for inhaled medicine,and enables the patient to take investigational medical products in accordance with the set protocol.

Hypodermic injection

Medicine for oral use

The brochure explaining how to take
the investigational medical products.

The brochure for inhaled medicine.

Inhaler

Pharmacists (CRCs) instruct patients
how to use the inhaler.

3) The staff meeting in the ward:

The CRC explaines the point which the staff should pay attention in order to administer the investigational medical products to the patient in accordance with the protocol.

4) Informed consent:

The investigators explain about the purpose,the risk and the benefit of clinical trial to patients in obtaining and documenting informed consent.
However,this process requires both effort and time.
Therefore, the CRC gives an auxiliary explaination of informed consent.

Informed consent

The written informed consent form.

5) Educational activities of clinical trials:

In Japan,almost all people have national health insurance.
Either they donﾕt know about clinical trials or,if they do know, they have a bad image of them.
For these reasons, it can be hard to obtain informed consent.
Therfore, we are making efforts to help patients learn about clinical trials and CRCs.

To help create a better understanding,we have created booklets entitled "Medicine and Clinical Trials" and "Clinical Trial News" and we have installed plasma displays in the outpatient lounges.
Each addresses these frequently asked questions:
"What are clinical trials?"
"What is a CRC?" and "What is informed consent?"

We have displayed
the booklets on the rack.

Clinical Trial News

Plasma displays are
connected with the
computer by LAN.

Homepage

part of an explanation

Contract achievement rates were 47% and 45% in 1997 and 1998, respectively.
After pharmacists began participating,the rate improved to 65%, 75%,79% and 81% in 1999, 2000, 2001 and 2002, respectively.
As for the efficiency on clinical trials, we reviewed how percentage the enrollment period pass away untill enrollment of all patients in our hospital.
It passed away 85%, 83%and90% in 1997, 1998, and 1999 respectively.
After pharmacists began participating, it passed away 74%, 66% and 66% in 2000, 2001 and 2002 respectively.
The efficiency of clinical trials improved slightly.

Pharmacists as CRCs contributed to the increase in contract instruction and efficiency.
But it isn't enough. As to that reason, we think

These problems canﾕt be solved only by the pharmacists.
However, we will begin actively recruiting.
Furthermore, we should study the plan to improve the efficiency of clinical trials from now on.