Clinical trial of a
New Medicine({name of investigational
product})－What’s a clinical trial?－

Name of your doctor:

Name of your clinical research coordinator (CRC):

A “clinical trial” is different from a normal medical examination. In aclinical trial, researchers study new medicines and treatments to see
how safe they are and how well they work. As we explain the details
about this clinical trial, please tell us at any time if you decide you

don’t want to take part in it. Please ask us any questions you may have.

You can also talk it over with your family before deciding. Your decision
not to take part will not change the quality of the care you receive.

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Contents
1

What’s a clinical trial? ....................................................................................................... 1

2

Disease and the investigational product................................................................... 2

3

The purpose of this clinical trial .......................................................................................... 3

4

Taking part .............................................................................................................................. 3

5

How will the clinical trial work?........................................................................................... 4

6

Potential risks and benefits ............................................................................................... 10

7

Promises for you to keep during the clinical .................................................................. 11

8

Other treatment options if you don’t take part ............................................................. 13

9

If you have side effects....................................................................................................... 13

10

Updates .............................................................................................................................. 13

11

Withdrawing from participation ..................................................................................... 14

12

Genetic testing .................................................................................................................. 15

13

Keeping your blood samples over the long-term ....................................................... 17

14

Privacy policy ..................................................................................................................... 18

15

Voluntary participation and withdrawal ........................................................................ 19

16

Institutional Review Board (IRB) ..................................................................................... 19

17

Consultation service ......................................................................................................... 20

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1What’s a clinical trial?

Medical treatments used today are based on a lot of research.

Preclinicaltest

Researchers test different chemicals to see if theymight be useful for treating a disease. They often

test new chemicals on living things like mice

5-10 years

before they are used with people.

Clinical After a new chemical passes the pre-clinical test, it is tested withtrial human volunteers in a clinical trial. The chemical is now called
an “investigational product” (IP) and is tested in three phases.

Phase1

Researchers give the IP to healthy volunteers
and/or patients to check its safety. They thenmeasure how much of the IP gets absorbed andhow much of it passes through the body.

Phase2

Only a few patients get the IP. After the patients get the IP,
the researchers measure the benefits, risks, and the bestamount (dosage) for making patients better.

Here

Phase3

Now, the researchers give the IP to many morepatients to see how well it works, what the risks
are, and what the best dosage is.

Inspection/ After the clinical trial is over, the drug company sends the results
Approval to the government to be checked by experts. If the government
experts think the IP is safe and effective, it gets approved as a
new medicine for use with patients.

Pre-market Researchers continue studying the new medicine after it has
study
been approved. They collect information about its benefits andrisks from many patients.

1

5-10 years

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2

Disease and the investigational product
About {name of disease}→Details

About {name of investigational product}

In this clinical trial, you will be asked to take tablets of {name ofinvestigational product}, which doctors believe may have the following
effects: { 1) effect, 2) effect}(Additional information: in case it is not approved in Japan){name of investigational product} is commonly used to help patients with{name of disease} all over the world, but {name of investigational product}has still not been approved for use in Japan.

(Additional information: in case a similar medicine has been approved)
Currently only {name of similar medicine} is available in Japan to treat{name of disease}, but {name of investigational product} works differently
from {name of similar medicine}. Here’s how:{difference between the two}

A clinical trial gives researchers a chance to test new drugs so thatpatients have more choices about their treatment in the future.

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3

The purpose of this clinical trial(Example)

The purpose of this clinical trial is to measure the effectiveness and risks

of using the investigational product (IP) in patients with {name of disease}.
During the trial, researchers will measure how much of the IP is absorbedby the body and how much passes through.

4

Taking partTo qualify to take part in this clinical trial, you must meet the following
requirements.

1)

Requirements

2)
3)
4)

1)

You can’t take part if you have even one of following.

2)
3)
4)
5)
6)
Even if you have all these requirements, you may still not be able toparticipate depending on your medical examination results.

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5

How will the clinical trial work?
Number of people taking part

Example 1

15 people in Japan
Example 2

15 people in Japan and 60 people from other countries
How long with this clinical trial last?

This clinical trial will last 6 weeks from the time you decide to take partin it.

{Number}days{Number}
Weeks{Number}
Weeks

Screening(Medical examinations to check that you can take part)
Using the investigational product (IP)

Observation (Medical examinations to check for
differences before and after taking the IP)

Type of IP and directions for taking it(Example)

Take one tablet twice a day, once after breakfast and once after dinner.
Insert a photo of investigational product4

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Dosage(Example)(In case of placebo)

You will help test the IP in one of three ways, called “regimens (REH-ji-

menz).”

A. You will be given lots of {name of investigational product};

B. You will be given a small amount of {name of investigational product};OR

C. You will be taking something that looks like {name of investigational

product} but doesn’t contain the product at all, called a “placebo” (pluhSEE-bo).

Same appearance

Different components
IPA

Large amount of the IP

B

Small amount of the IP

CNo IP at all! (Placebo)

If you get regimen A, you may get better but you may also become worse,
as we will explain in “Chapter 6: Potential risks and benefits.”

If you get the placebo (tablet C), your condition will not change or may

even become worse because it doesn’t do anything.
Why use a placebo?

Some people feel better after taking a placebo because they
believe it is working. Researchers use placebos so thatthey can get a better idea of how the IP is working bycomparison. In this way, researchers can measure an
IP’s effectiveness and its health risks accurately.

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Which regimen you get will be decided automatically and even you, yourparents, and the researchers will not know until after the clinical trial.

If you feel sick or feel uncomfortable, please tell your parents or the

researchers right away. The researchers will examine you carefully andgive you something to make you feel better. Also, if your test results showthat it’s unsafe for you to continue, the researchers may stop you fromtaking part any further.

You can quit the clinical trial anytime when you wish. Your decision to quit

will not affect the quality of the care you receive. Please tell the
researchers or the CRC if you want to quit.
(In case a Forced titration)

First, you’ll be asked to take small amounts of the investigational product,
then bigger amounts every three days while we check to make sure thateverything is OK with your health. This is important to judge what amountis best for patients the same age and weight as you.
(In case a Dose titration)Example

First, you’ll be asked to take small amounts of the investigational product,
then bigger amounts gradually until we can see an effect while we checkto make sure that everything is OK with your health. This is important tojudge what amount is best for patients the same age and weight as you.
Every 3 days

1st day

Every 3 days

4th dayDose

6

7th day…

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Dose

The number of times you take itis the same but the amount ineach tablet increases.

1st day

4th day

7th day7

Days

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Schedule

You will be asked to take the following medical examinations according to the schedule below.
Screening
Time
Explanation/
Consent
Medicalexamination

During IP use
Start

2nd week

4th week（±3days）

Blood pressure
Pulse
Body temperature
Urine test
Blood test
IP in blood
Lung function test
Diary
Genetic testing **We will explain the details in Chapter 12.

8

8th week

Observation
12th
week

20th
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28th
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Example・ Lung function test
This test checks the size and movement of your lungs
when you breathe. A mouthpiece (tube) will be placed inyour mouth, and you’ll be asked to breathe following thenurse’s directions.

Please tell us if it’s difficult for you to breathe or you feelsick so you can take a rest.

・Measuring the IP in your blood
A blood test tells how much of the IP stays in your blood and how
much of it is working. Shortly after you begin taking the IP, you will be

asked to take a blood test using either (1) a normal injection needle or(2) a soft tube inserted into your vein. You can choose whichever you
like better. You may have some pain or feel a little sick during a blood
test. There will be about five blood tests during the clinical trial.

To measure the amount of the drug in your blood, you may be asked
to visit the hospital even on a day when you haven’t taken the IP.

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6

Potential risks and benefits
Potential benefits

You may or may not get benefits from taking {name of investigational
product} because research on this IP is not over yet. The effectiveness ofthe treatment depends on the person taking it.
Potential risks

You may have to get frequent medical exams.

You may also get one or more of the following symptoms.
Percentage

Symptoms％

Itching and hives％

Feeling sick％Sweating％％
You may get other symptoms.

If you think something’s not right, please tell the researchers right away.
They will give you something to make you feel better.

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7
1.

Promises for you to keep during the clinicalSee the researcher when you’re supposed to

A researcher will examine you often to check the effectiveness of the IP
and to make sure that your health is OK.

2. Ask your family before you take any other medicine

Some medicines can’t be taken during the clinical trial.

If you feel sick, before you take another medicine be sure to ask yourfamily if it’s allowed. And please write down (or ask your parents or

guardians to write down) the name of the medicine and the date you took
it in your medical diary.

3. Tell us about any other treatments

Please tell your parents and the researchers if you intend to have anothertreatment for any other illness, including dental treatments.

4. Bring your “clinical trial card” whenever you go to another hospitalor pharmacy

If you visit another hospital, please show your “clinical trial card” to thedoctors or pharmacists there and tell them you are taking part in a clinical
trial and are not allowed to take certain kinds of medicine.
5. Keep a diary for during your clinical trial

Please keep a diary with your family to write down each time you take the

IP and how you feel. Please bring the diary with you whenever you visit
the hospital and show it to the researchers and the CRC.
6. Bring all the IP you have to the hospital

Please don’t throw away any leftover IP, including the empty cases andbags. Give them to your parents and bring all of them to the hospital.
7. Birth control during the clinical trial

The researchers cannot say yet how taking the IP may affect your ability

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to have a baby or breast feed it. Please be sure not to get pregnant during
the clinical trial.
-For girls

If you discover that you are pregnant, please tell your parents or the

researchers right away so that you can stop taking part in the clinical trial.
-For boys

If you find that your partner has become pregnant, please tell yourparents or the researchers right away so that your partner and her baby
can be examined to make sure they’re OK.

* Add an explanation about contraception by referring to the text
suggestions as necessary (see: For women, For men, Contraception).

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Other treatment options if you don’t take partYou can receive other treatments that have already been approved even
if you decide not to take part in this clinical trial.
{name of treatment}

9

If you have side effects

If you feel uncomfortable, please tell your parents and the researchers

right away. The researchers will watch you closely and give you
treatments to make you feel better.

10

Updates

If a new health risk, etc. of the IP is discovered while you are taking partin this clinical trial, the researchers will inform you and your family rightaway. Based on this new information, you can decide whether or not you
want to quit the clinical trial. Please let us know if you’d like to quit.

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Withdrawing from participation

A clinical trial may be stopped for any of the following reasons.

Also, you may be asked to stop taking part if you do not follow the rules
in Chapter 7.

1. You and your parents or guardians decide to stop yourparticipation.

2. The researchers say you should stop for some health reasons.
3. (If you are a girl) You are pregnant.

4. The researchers think the IP is not working or that you may be
at risk of severe effects or injuries related to this trial.

5. The drug company conducting this clinical trial decides to stop thetrial.

6. The Institutional Review Board decides to stop the trial.
The researchers will continue to examine you and give you othertreatments even if you stop taking part in the trial. You may receive
additional medical examinations to make sure your health is OK when you
withdraw or afterwards.

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12

Genetic testingThis clinical trial includes genetic testing. Your genetic test concerns yourfamily and your future children.

What does “genetic” mean?

Genes, which contain your body’s “blueprint,” make it possible

for parents to pass traits like eye color and hair color on to theirchildren. Each of us carries genetic information fromeach of our biological parents. Some genes are related
to certain diseases and can affect the effectiveness andhealth-related risks of medical treatments.

Genetic testing: purpose and procedures(Example 1)

The purpose of the genetic test in this trial is to find out how well the IP
is working in patients depending on specific differences in their genetic

information. This is the only reason for doing the genetic tests in this trial.
(Example 2)
The researchers in this trial will ask you and other volunteers to take agenetic test to diagnose {name of disease}. Those who receive a diagnosisof {name of disease} can then take part in the clinical trial.
(Example 3)

The researchers in this trial will do genetic tests to get specific genetic
information that they need to measure how well the IP is working. Once

we have decided when and how the genetic tests will be conducted, we
will let you know.

On week {number} of your hospital visits, you will receive several tests,and {quantity} ml of blood will be collected for testing. The blood used

for genetic testing will be kept by a special agency for a maximum of{period}, then will be safely disposed of.

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Potential risks and benefits(Example 1)

Genetic testing will not give any benefits to you personally, but it may be

used to develop new treatments and medicines that can help many
people in the future. Some people feel anxious about their genetic test

results. Also, there is a risk that your genetic test results, which are part ofyour private information, might be leaked. However, the drug company
sponsoring the clinical trial has promised to control your genetic test
information strictly so that it doesn’t become public.
Disclosure of your genetic test results(Example 1)

The researchers cannot tell you the results of your genetic test.

(Example 2)

Please ask your parents or the researchers if you want to know the resultsof your genetic test.

It may take some time until the results of your test are available. You may
talk to a genetic counselor if you wish.
Before you take a genetic test

(In case of required screening)

To take part in this clinical trial, you need to take a genetic test. Before

you agree to take part in the trial, please consider carefully whether you
want to receive a genetic test and take part in the trial.

You can withdraw from the trial at any time if you change your mind. If
you quit the trial, your blood sample will be safely disposed of, but any
data we get before you quit will be kept for further study related to thistrial.

(In case pf voluntary screening)

Having a genetic test is completely up to you. Please think it over carefully
with your parents before deciding either way.

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Please let your parents and the researchers know right away if you don’t
want to take part or if you change your mind after starting the trial. Again,
you can quit this clinical trial anytime you wish.

If you quit the trial, your blood sample will be safely disposed of, but any
data we get before you quit will be kept for further study.

You can continue to take part in this clinical trial even if you choose not
to take a genetic test or decide to stop the test after it has started.

13

Keeping your blood samples over the long-termYour blood sample will be preserved for the long term and tested again
in the future if additional research is needed to find out the parts of the
IP that are effective against {name of disease} and their risks and benefits.

The additional research study may include tests where your genetic

information is disclosed (Please refer chapter 12, Genetic testing). At the

moment, however, no additional studies are being planned nor can we
say when such studies may be done or what their purpose will be.

You and your parents should decide if you agree to long-termpreservation of your blood samples and its use in additional research. You
can take part in this clinical trial even if you decide your blood samples
should not be preserved in the long-term.

We will safely dispose of your blood sample at any time you wish during
this clinical trial, but any data we get before you quit will be kept for
further study.

Please ask the researchers if you wish to know more about the additional

studies. Please remember that these additional studies may not be doneor may not be completed while you are taking part in this trial.

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Privacy policy“Personal information” is information about people, like their name,address, phone number, and so on.

The information collected in this clinical trial will include things that are

unique to individuals, like their birthday, medical history, and test resultsthat can be used to find out who they are. Your personal information will

be given to the pharmaceutical company for protection and be used instudies after removing information that can lead back to you.
An alphabet and number code will be used instead ofyour name.
Example:John Doe→A001
The people at the pharmaceutical company who are in charge of thisclinical trial and workers at the Ministry of Health, Labour and Welfare
may check your medical records to make sure that this clinical trial isbeing done properly. However, when they check your medical records,

they will follow strict rules to keep your information from becoming
public. Your personal information will never be leaked.

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Voluntary participation and withdrawal

Please think carefully whether or not you wish to take part in this clinical

trial. Your decision is the most important thing. Even if you choose not totake part, the researchers will give you other, standard treatments to help
you feel better.

If you change your mind during this clinical trial, please discuss yourfeelings with your parents and the researchers before deciding. Whether

or not you choose to continue taking part, you will go on receiving all theservices you have been getting.

If you decide to quit after taking the investigational product (IP), you may
receive a medical examination to make sure your health is OK. Please
follow the researchers’ directions and ask them or the CRC (ClinicalResearch Coordinator) if you have any questions or if something isbothering you.

16

Institutional Review Board (IRB)

Clinical trials are done following strict regulations to protect patients’safety and human rights. All clinical trials need to be approved by theInstitutional Review Board (IRB). The IRB monitors the researchers tomake sure that they are following the rules, protecting the patients’ rights,
and conducting the clinical trial safely. The IRB has already reviewed thisclinical trial and has given permission for it to be conducted.

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Consultation service

If you want to know more about anything related to the clinical trial or

you feel anxious, you can talk to your parents, the researchers or the
consulting service below any time you wish. We will be happy to explain
everything to you until you and your parents understand completely.

If you experience anything unusual during or after this clinical trial, pleasetell us right away.

Name ofinstitution
Contact(Example) ABC hospital(Example) clinical trial office

Phone number

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Hospital Copy●●●

Letter of Assent●●●

I have learned everything I want to know about {name of investigational
product} and agree to take part in this clinical trial.
I agree to be genetically tested.

 Yes ( I agree to disclose the results □ Yes □ No )
 No

Regarding the use of my blood samples for additional studies: I agree to have my blood samples preserved for the long term.
 I agree to have my blood samples preserved for the long term
without tests disclosing my genetic information.

 I wish my blood samples to be disposed of safely.
Date:

/

/

Year

month

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date

Name:
・・・Investigator・・
Date:

Year

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month

date

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Name:
・・・CRC・・・
Date:

Name:

/

Year

month

date

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Clinical Trial Office Copy●●●

Letter of Assent●●●

I have learned everything I want to know about {name of investigational
product} and agree to take part in this clinical trial.
I agree to be genetically tested.

 Yes ( I agree to disclose the results □ Yes □ No )
 No

Regarding the use of my blood samples for additional studies: I agree to have my blood samples preserved for the long term.
 I agree to have my blood samples preserved for the long term
without tests disclosing my genetic information.

 I wish my blood samples to be disposed of safely.
Date:

/

/

Year

month

/

/

/

date

Name:
・・・Investigator・・
Date:

Year

/

month

date

/

/

Name:
・・・CRC・・・
Date:

Name:

/

Year

month

date

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Patient Copy●●●

Letter of Assent●●●

I have learned everything I want to know about {name of investigational
product} and agree to take part in this clinical trial.
I agree to be genetically tested.

 Yes ( I agree to disclose the results □ Yes □ No )
 No

Regarding the use of my blood samples for additional studies: I agree to have my blood samples preserved for the long term.
 I agree to have my blood samples preserved for the long term
without tests disclosing my genetic information.

 I wish my blood samples to be disposed of safely.
Date:

/

/

Year

month

/

/

/

date

Name:
・・・Investigator・・
Date:

Year

/

month

date

/

/

Name:
・・・CRC・・・
Date:

Name:

/

Year

month

date