How to participate in clinical trials:

At Pacific Grove Co., Ltd., we treat each clinical trial volunteer as our partner. We communicate directly with each individual to promote effective and smooth clinical trial participation.

 

Part of our communication effort is our registration and information sessions that take place twice daily, from Monday to Friday. During these meetings, our professional instructors explain clinical trials and answer any questions you may have. This makes clinical trial participation easy!

 

We have a support system, which is always available, to resolve any concerns that you may have. We aim to understand our volunteers’ physical condition by making sure we have a reliable support system in place and open lines of communication including e-mails, phone calls, faxes, and letters, as well as questionnaires and medical checkups. Please feel free to contact us.

 

What is a clinical trial?

Scientists work hard to discover compounds which have the potential to effect human diseases. These substances can come from plants, fungi in the soil, marine life, etc., or are developed from chemicals, in a lab. First, the compound’s safety is tested using animal tests or test tube experiments. If they seem safe and promising, the compound may be chosen to become a “candidate drug.”

 

 It is very important to investigate the efficacy and safety of candidate drugs. Usually, they are tested first in a small group of healthy volunteers. Then the tests move into the next phase with larger groups of patients with the target disease.

 

The results of all the tests are carefully examined by the government. Then, if the candidate drug is approved as safe and necessary for the treatment of diseases, it is made into an actual drug.

 

Tests on humans are generally referred to as “clinical studies.” Clinical studies conducted to gain government approval are referred to specifically as “clinical trials”.

(From the homepage of the Ministry of Health, Labour and Welfare of Japan)

 

Clinical trials are carried out in hospitals according to guidelines published by the Ministry of Health, Labour and Welfare.

 

Only hospitals satisfying the requirements outlined in the rules, “Ordinance on the Standards for the Implementation of Clinical Trials” are chosen for clinical trials.

 

The requirements are:

・Sufficient medical equipment

・A trained team of qualified doctors, nurses and pharmacists, etc. who will be responsible for carrying out the clinical trial

・A committee to examine the details of clinical trials

・Necessary medical treatment and measures can be implemented immediately In case of emergencies

 

Patients can participate in clinical trials with confidence

Clinical trials are carried out closely following strict standards which are set by the government the Ministry of Health, Labour and Welfare (Ordinance on the Standards for the Implementation of Clinical Trials; GCP). In order to participate in a clinical trial, a patient will receive detailed explanations about a clinical trial from the doctors who will perform the clinical trial. After fully understanding about the study, they can choose whether or not to participate based on their own judgement.

 

Human rights and safety of the participants are respected, and personal information is very carefully protected. At Pacific Grove Co., Ltd., we have the “P mark” that allows the use of “Privacy Mark.” This is awarded to business operators who meet certain standards based on an evaluation of whether they are handling personal information appropriately.

 

Participating in a clinical trial allows a patient more detailed examinations and more thorough treatment than is usually provided to patients receiving normal treatment. What’s more, clinical trial participants do not pay for any medicine or tests relating to the clinical trial. Finally, they can contribute in the production and release of a new drug into the world.

Steps of drug development via a clinical trial

Clinical trials go through three stages called, “phases.” The development of a medicine must progress through the phases to confirm its safety and efficacy. Then, the results of each clinical trial test are submitted to the Ministry of Health, Labour and Welfare when applying for approval to go to market.

Phase 1

In a small number of healthy adults, the dosage of the candidate drug is gradually increased from very small doses to investigate its safety.

Phase 2

The efficacy, safety, dosage, and method of administration, etc. of the candidate drug are investigated in a relatively small number of patients.

Phase 3

The efficacy, safety and method of use are confirmed in a large number of patients.

 Five reasons to choose Pacific Grove Co., Ltd.

We have 340,000 volunteer members

Our Clinical Trial Volunteers Group JCVN has 340,000 volunteer members with strong motives for participation in clinical trials. Our members are eager to contribute to the development of more effective and safer drugs to help people suffering from diseases.

We have enrolled members from their 20s to 80s!

We have a record of recruiting more than 2,000 people (phase I trials) and treatment period transition records of 5,397 elderly people in phase II and III trials (as of February 2017).

We improve successful entry rates by performing accurate pre-screening

We select the most appropriate candidates to participate in specific clinical studies based on their medical checkup data. Our volunteers are informed about clinical trials and agree to participate in clinical research.

We accommodate a broad range of diseases from life style-related to rare diseases

Our members have diverse diseases from life style-related diseases to rare diseases, and their disease information is input in our database. The most suitable candidates for a clinical study are selected which increases the number of referred cases.

We have rich experience testing cosmetics and health-promoting foods with special function claims

We have 11 years of experience testing foods, beauty products and others, involving around 50,000 people in approximately 4,000 tests.

 Five steps to become a clinical trial volunteer

1.Member registration

If you are interested in joining our Clinical Trial Volunteers Group called JCVN, please visit our website to register. Participation in clinical trials is based on ‘GCP’ (Good Clinical Practice which is the standard for the implementation of clinical trials). We encourage you to participate based on your own decision. For volunteers, participation in clinical trials is free and there are no fees at all associated with registration.

2. Attending registration and information sessions

We would also like to encourage you to attend a registration and information session at our office, which is near JR Gotanda Station. Our trained staff members give lectures on basic knowledge of clinical trials and the mental attitudes needed for participation in clinical trials.

3. Selection of candidates

We make lists of appropriate candidates for specific clinical trials using our volunteer database. The information includes prefecture, clinical laboratory test results and medication being taken and.

4. Screening by phone

Using the list, we will check each candidate’s eligibility for the specific clinical trial based on a detailed SCR (Standardized Claim Ratio=age adjustment, appearance ratio of standardized receipt) which complies with the clinical trial’s participant criteria.

5. Providing the applicant list to the requesting institution

The list is then sent to the client (at the clinical trial site). We update the status of clinical trial participation using our volunteer management system.

Pacific Grove Co., Ltd.

 

2F Yamate Building

3-14-35 Kamioosaki, Shinagawa, Tokyo

141-0021

TEL:03-5791-7795 (reception)

Copyright (c) 2018 Pacific Grove Co., Ltd. All Rights Reserved.

How we handle personal information.

Pacific Grove Co., Ltd. (hereinafter referred to as “we”, “us”, “our”) recognizes the importance of protecting personal information. We believe that proper handling and protection of personal information is a fundamental part of our business activities and our social responsibility. We engage and build trust under the following policies:

(1) If we are to keep any personal information, we ensure the purpose of its use is clear and it is only used it within the scope specified.

(2) We do not share personal information with any third party, other than approved parties, except to fulfill our responsibilities of agreement or in the case of other justifiable reasons.

(3) In order to manage personal information safely and appropriately, we set appropriate security measures in place to secure personal information against unauthorized access and ensure it is safe from loss, destruction, tampering, or leakage.