CLINICAL TRIALS………… JAPAN

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Clinical trials

Clinical trials, also known as clinical studies, are scientific studies of drugs, medical devices or other treatments in humans. These studies are most often conducted for the following reasons:

  • To verify the safety and effectiveness of potential drugs, medical devices or other treatments,
  • To compare trial-treatments against existing treatments,
  • To determine better ways to use treatments to make them more effective, easier to use, or to decrease side effects,
  • To determine how best to use a treatment in a specific population. For example, in children or in a particular ethnic group.

Clinical trials for new drug development

There are three main stages in clinical trials for drug development: Phases I, II and III. Phase I clinical trials are conducted with 50~200 healthy participants and involve incremental dose increases of investigational drug within a predefined dose range to evaluate tolerability and safety, monitor food and drug interaction, as well as gather information about what the drug does to the body (pharmacodynamics1(PD)) and what the body does to the drug (pharmacokinetics2 (PK)).

1 Pharmacodynamics (PD) is the study of a drug’s biological and physiological effects on the body. Examples of physiological effects include changes in heart rate, blood pressure or blood glucose level.

2 Pharmacokinetics (PK) is the study of the mechanisms and rates of drug absorption, distribution, metabolism and excretion after administration of a drug.

This information is vital in understanding how safe a drug is, how it works, potential as a treatment, and appropriate dosage levels for safe and effective usage. A series of phase I trials typically take about 1 year to complete. If successful, these would lead to Phase II patient trials incorporating 100~400 participants to assess drug efficacy, provide further information about safety, and establish proper dosage. This process can take about 2 years to complete, after which, larger scale Phase III patient trials can begin with as many as 1,000~5,000 participants enrolled under the wider supervision of general physicians, hospitals and clinics. These studies take about 3 years to complete before, if successful, the data is submitted to the relevant regulatory authorities to obtain marketing authorization for the new drug. After review and approval by regulatory authorities the drug can be made available to the general public.

Caucasian inclusive clinical trials in Japan

In Japan, clinical trials for drug development are called chiken (治験). Generally speaking chiken focus on Japanese subjects only, but in cases where international drug development entails consideration of multi-ethnic studies, or where pharmaceutical companies wish to submit Caucasian Phase II ~ III data from overseas for drug approval here in Japan, multi-ethnic comparative PK studies may be required. In such cases, carrying out these studies in Japan can be a viable option for sponsoring pharmaceutical companies.

Introduction to Caucasian clinical trials in Japan

These multi-ethnic comparative PK studies are generally Phase I trials as described earlier. In these studies Japanese and Caucasians, and/or other ethnic groups, participate as separate groups in a single trial at a single site. Each group is given the same investigational drug at the same doses, with the same diet and the same routine. The significance of this is the achievement of excellent comparability through standardization of operating procedures and equipment, and reduced variation in human technique and judgement. Collectively this results in higher quality and more robust data about the drug being studied.

Clinical trial organisers

InCROM (International Clinical Research Organisation for Medicine Ltd) is the Site Management / Clinical Research Organisation responsible for the management of clinical trials conducted at its affiliate medical facilities. In the case of Caucasian inclusive studies, these facilities are Koganeibashi Sakura Clinic in Tokyo and Osaka Pharmacology Clinical Research Hospital (OPHAC) in Osaka. Clinical trials are typically commissioned by a sponsoring pharmaceutical company, which outsources its research and development to clinical research specialists such as InCROM, that have the experience, knowledge, staff and facilities to carry out these studies safely and smoothly.

InCROM Volunteer Centre is a major source of recruits for InCROM trials, with a Japanese database of about 40,000 registered members and a growing database of Caucasian volunteers.

With a strong international presence, more than 400 dedicated staff and over 60 affiliated medical facilities engaged in Phase I through to Phase III and post-marketing trials, InCROM Group is a recognised leader in the clinical research field. InCROM Group has conducted over 1,100 Phase I clinical trials and more than 400 Phase II or later phase trials (including overseas trials) and we are proud to count all of the major global pharmaceutical companies amongst our client base.

Clinical trial organisers

For more information please see the InCROM Group website.

Your safety

In Japan, as in Western countries, the conduct of clinical trials is strictly legislated and administered by government regulatory authorities. Here in Japan, those authorities are theMinistry of Health, Labour and Welfare (MHLW) and the Pharmaceutical and Medical Devices Agency (PMDA). Clinical trials are conducted in accordance with Japanese standards for Good Clinical Practice (Japanese GCP), which are based upon International standards for Good Clinical Practice (ICH-GCP). These standards include a requirement for independent review of each trial protocol (the detailed trial plan) by a qualified clinical trial review board. This committee, referred to as an Institutional Review Board (IRB), consists of a team of impartial medical professionals, medical institution representatives and regular citizens. To ensure the rights, safety and well-being of clinical trial participants, it is the duty of the IRB to review trial protocols and procedures and the materials to be used in obtaining and documenting informed consent (see below).

All trials conducted by InCROM are reviewed thoroughly before and throughout conduct, by this qualified Institutional Review Board. All medical facilities are government approved and highly competent medical and clinical professionals supervise all trials. When you are invited to apply to participate for a specific study, you will be provided with information about the trial purpose, the trial drug, time frames, procedures, your rights, compensation, etc. It is only with a full understanding of the above that you will be permitted to register to participate in a trial.

Many people express concern about the potential side effects of investigational drugs. The first thing to note however is that all drugs, including the ones we take for common colds and headaches, produce side effects. Side effects are the secondary effects of taking a drug – that is, any effect other than the intended therapeutic effect that lessens or stops the symptoms of a disease or condition. These secondary effects may be unnoticeable, could include cold-like symptoms, dry throat, stomach cramps or drowsiness, and in rare cases, could include symptoms of a more serious nature.

In Japan based Caucasian studies planned by InCROM, safety data about the drug has already been collected and suitability for trial continuation has been established.

Your safety

Trial time frames

The time frames for every trial are different, but as a rough guide, our studies will typically require a hospital stay of several nights to several weeks. During this time you will need to stay in the hospital, eat the prescribed diet and refrain from overexertion. You will need to cooperate for ongoing blood and urine sampling, temperature, blood pressure and other vital sign checks. After hospital discharge there may also be several non-stay follow-up visits required.

Course of events for a clinical trial (example only)

* Regular checks’ includes blood and urine sampling

Compensation for participation

As a healthy volunteer participating in a clinical trial, it is unlikely you will derive any direct health benefits from participation. This being the case, to compensate you for your time and any discomfort experienced during the trials, an honorarium is provided. The amount of compensation may vary according to the study, but in general this is based upon the number of hospital visits and the length of the hospital stay. Specific details about compensation are provided in the informed consent form for each study, however you may contact us at anytime for generic details..

Enrolling to take part

To take part in a clinical trial, you need to fill in an online or post-out registration form to become a member of our volunteer panel.

This registration allows us to match upcoming trial requirements with your profile and then to contact you with basic details about studies you may be interested in participating in. If you are interested, we then invite you to a more detailed trial briefing. This will cover the purpose, duration, procedures, your rights, any potential risks associated with participation in the trial, compensation, and confidentiality requirements etc. This also provides a face-to-face opportunity for you to ask questions.

Following on from the briefing, before you are enrolled (or participate) for a trial, it is a requirement that you give ‘Informed Consent’3. This is essentially the same form of consent required of patients undertaking any serious treatment or medication provided by a doctor. Detailed information will be provided to you both verbally and in writing. You will also be given time to consider, consult with those you trust, and to contact us with any further questions you may have before, should you wish to, signing and returning the completed Informed Consent form.

3‘Informed Consent’ is a legal condition whereby a person can be said to have given consent, based upon a clear appreciation and understanding of the facts, implications and future consequences of their actions – in this case participation in a clinical trial.

This document verifies that you participate out of your own free will, and with full understanding about the nature and implications of your participation. Note that even once you have given Informed Consent, you may withdraw from a trial at anytime without explanation.

Once your Informed Consent is received you will receive a medical check and an interview to confirm that you are in good health and that you meet the conditions for participation.

Enrolment restrictions

Restrictions vary by trial, but in general the main things that would prevent you from participating in a trial are:

  • Insufficient time lapse between participating in studies: Usually, a 3-month break between periods of participation is required.
  • Participating in more than one trial for the same drug: Regardless of time frames this is not allowed.
  • Recreational drug use (marijuana etc.): Recreational drug users are not allowed to participate in clinical trials.
  • Smoking: There are many instances where smokers cannot participate or you will be asked to refrain completely while participating in the trial. If you are a smoker please keep this in mind if you intend to register to participate.
  • In the days preceding a trial you may also be asked to avoid products containing caffeine, alcohol and grapefruit, as these substances can significantly alter drug action and absorption, and negatively affect the results of the study.
  • While a working visa is not a requirement of participation please note that tourist visa holders are bit eligible for participation.
  • In some cases it will be necessary to hold follow-up checks or interviews. For this reason we ask that participants intend to remain in Japan for at least several months from the completion of the trial.

For the medical and hospital stay

  • You will need to show your Alien Registration Card and passport when you visit the hospital for the medical check and trial admission. We will keep a photocopy on file.
  • For hospital stays the hospital will provide towels, pyjamas, soap, toothbrush and toothpaste, shampoo and conditioner, disposable razors and slippers.
  • You will need to bring sufficient underwear and any other personal items you may need.
  • Televisions, DVDs Internet access at our computer room will be made available.
  • Do not bring food or drink to the hospital. During a trial all meals are set and provided according to a study plan and any variation from this is likely to negatively impact the study.

Things to bring to the medical check and hospital stay

Other points to note

  • Your full cooperation will be expected at all times.
  • We ask that you are considerate and courteous to staff and other volunteers.

I’d like to know more…

  • Personal Information Protection Policy

    As a company engaged in clinical trials, InCROM considers the protection of personal information to be a serious social responsibility. When handling personal information in our business activities the protection of this information is one of our highest priorities. To ensure personal information protection, the following policies have been established:

    (In accordance with these policies, all InCROM employees will make every endeavour to ensure appropriate handling and administration of both internal and external personal information. These policies are made public on the Company’s homepage and in other publications (in Japanese only)).

    1. Personal Information Administration
      1. A personal information protection system shall be prescribed and information shall be handled accordingly.
      2. The following positions shall be appointed to carry out the stipulated responsibilities of personal information handling: A Personal Information Manager, a Manager for education on personal information handling, a person responsible for grievances and consultation and a person responsible for internal auditing.
      3. All employees shall be made fully aware of the requirements for personal information handling and the need for extreme care to avoid any leakage of information to any outside parties.
    2. Acquisition, Utilisation and Transfer of Personal Information
      1. When InCROM accepts an individual’s personal information, the individual’s consent to use the information shall also be obtained after providing a clear explanation of its intended use, and the nature and scale of InCROM’s business activities. Further, where an individual’s personal information is to be provided to or handled by a third party, that individual’s consent must be obtained.
      2. Disclosure, correction or deletion of an individual’s personal information will be allowed within reason, at the request of that individual or that individual’s legal representative(s).
      3. Special consideration shall be given to the handling of personal information of persons under the age of 20. Consent from the legal guardian shall also be required.
    3. Personal Information Security
      1. The person(s) responsible for the handling of personal information shall be specified and the number of people given access to this information limited. InCROM will make every endeavour to ensure the prevention and correction of unauthorised access to personal information, leakage, loss or damage etc of personal information, and to ensure that security of personal information is maintained.
      2. Where the handling of personal information is outsourced to a third party, the third party selected shall be a Privacy Mark approved company or acknowledged as meeting comparable standards for personal information protection. Further, where a third party is contracted for the handling of personal information the requirements for handling will be stipulated by contract and every endeavour made to ensure the information’s security.
    4. Regulatory Compliance
      1. With respect to personal information handling, all laws, national policies and applicable standards shall be complied with.
      2. In addition to setting company rules for personal information handling in accordance with relevant laws, national policies and JISQ15001, rules shall be reviewed and improvements made on an ongoing basis.
    5. Continuous revision
      • The implementation of Policies 1~4 (listed above) will be assessed regularly by audit and every endeavour will be made to ensure the ongoing improvement of the Personal Information Management System.
      • If you have any questions or opinions you wish to share in regards to personal information handling, please contact us at the details below:
    Grievances and Consultation Contact
    InCROM Group
    SMO Division, Volunteer Recruitment Department
    Tel: 0120-1966-94 (Mon ~ Fri 9:00~17:00)
    Email: kojinjoho-info@incrom.com

Handling of Personal Information

Personal information shall be handled in accordance with standard agreements between InCROM and its partner medical institution(s).

Personal information shall include

  • Address, Name, Phone number and other information specific to an individual
  • Medical information including medical history, laboratory/physical test data etc
  • Clinical trial participation status (history)

Provision of the above information is not mandatory, however, where necessary information has not been provided, volunteer registration may not be accepted.

InCROM promises to handle personal information in accordance with laws and regulations for the protection of personal information, to review internal rules and handling systems as necessary, and to ensure strict and careful administration of personal information.

Use of personal information

InCROM will only use personal information for the following purposes:
Clinical trials
Correspondence between InCROM and individual volunteers

(Personal information will not be used for other uses without the owner’s permission).

Requesting changes to personal information

InCROM shall respect individual’s rights with respect to their personal information. Should an individual request viewing, correction, addition, deletion, discontinuation of use, or refuse to allow provision of personal information to a third party, these wishes will be followed in accordance with standard agreements between InCROM and partner medical institution(s).

To request any changes to your personal information or its handling please see the notes below. Also, to ensure that your personal information is kept accurate and up to date please notify us of any changes to your address, name, place of work or education, email address etc.

Who can make requests?

  • Requests can be made by the individual to which the personal information pertains or the legal/nominated representative of that person.
  • Where requests are made, verification of identity will be required.
  • Where a legal/nominated representative makes a request on an individuals behalf proof of right to act on that individuals behalf (proxy) will also be required in the form of an official document (or its copy).

Requests cannot be accepted in the following instances

  • Where the request form is filled out incorrectly or incompletely
  • Where identity cannot be confirmed
  • Where the right to act on behalf of an individual cannot be confirmed
  • Where the subject of the request form does not match the information disclosed
  • Where law prevents the execution of the request
  • Where the request will cause significant damage to, or risk of damage to, InCROM’s business

Please understand that your personal information will be shared between InCROM and the medical institution(s) with whom InCROM has contracted to for the conduct of clinical trials. Your personal information will not be provided to any other third party without your permission.

Further to the above, personal information will be handled in accordance with law (Law No.57 30 May 2003).

Enquiries

For enquiries regarding personal information handling, please contactmakoto.tsunoda@incrom.com or phone 0120-72-8343(Makoto Tsunoda).

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One thought on “CLINICAL TRIALS………… JAPAN

    DR ANTHONY MELVIN CRASTO Ph.D responded:
    September 4, 2014 at 3:48 am

    Reblogged this on New Drug Approvals.

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