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Clinical trial and study guide
About clinical trials
Many people may have vaguely heard of clinical trials and studies, but this may be their first time applying for or participating in one.
We will explain as clearly as possible to alleviate any anxieties about Food and daily necessities clinical study and to enable you to apply and participate with confidence and peace of mind.
Many people may have vaguely heard of clinical trials and studies, but this may be their first time applying for or participating in one.
We will explain as clearly as possible to alleviate any anxieties about Food and daily necessities clinical study and to enable you to apply and participate with confidence and peace of mind.
Index
What is a clinical trial?
Until a medicine is developed
Aren't clinical trials scary?
The merit and demerit of participating in a clinical trial
Related information
What is a food and daily necessities clinical study?
Flow of participation
FAQ
What is a clinical trial?
A clinical trial is a clinical study conducted to confirm the efficacy and safety of an unapproved "drug candidate (investigational drug)" in humans. Depending on the results, the drug can be approved by the Ministry of Health, Labor and Welfare and then used in general. Clinical trials are an important process to ensure that new drugs can be used safely in the future. Many people may hear similar terms such as "clinical research," "clinical study," and "clinical trials" but are not sure of the difference between them. Clinical trials are part of clinical study. Clinical study is conducted to confirm the efficacy and safety of pharmaceuticals, cosmetics, and food products.
Until a medicine is developed
To develop a new drug, It takes more than 10 years and costs more than 10 billion yen, and it is made carefully in stages.
Basic research
2-3 years
Discovery and production of new substances that can become medicines
Non-clinical (animal) trials
3-5 years
Verify efficacy and safety using cultured cells and animals
Clinical trials and studies
3-7 years
Verify efficacy and safety in humans
Phase 1
Safety study in healthy adults
Phase 2
Safety and efficacy will be tested with a small number of patients
Phase 3
Final confirmation of safety and efficacy will be conducted on a large number of patients.
Application and review
About 1 year
After applying to the Ministry of Health, Labor and Welfare and passing a rigorous examination, the drug is approved for production and sale.
Aren't clinical trials scary?
Participation can be decided after receiving sufficient information
The clinical trial physician and clinical trial coordinator will provide you with a thorough explanation of the clinical trial from every angle in advance. If you have any questions or concerns, you can ask them without hesitation, and you can decide whether to participate only after you fully understand and agree with the terms. (Informed consent)
Even after deciding to participate, you can quit at any time, and patients will not suffer any disadvantages if they decline to participate or quit in the middle of the trial.
Strict implementation mechanism to prioritize safety
Clinical trials are conducted under laws that prioritize the human rights and safety of participants, as well as strict rules set by the Ministry of Health, Labor and Welfare.
As mentioned above in "Until a drug is made," clinical trials first check safety and effectiveness on cultured cells or animals. If there are any problems at this stage, such as serious side effects, trials on humans will not be conducted. Safety is confirmed in stages over a period of several years.
Although clinical trials are conducted carefully in this way, the possibility of side effects cannot be denied. In the unlikely event that health damage occurs, appropriate compensation will be available from the pharmaceutical manufacturer unless the causal relationship can be completely denied.
The merit and demerit of participating in a clinical trial
Merit
Detailed examination
You can get a detailed examination and understand your condition.
Increased treatment options
It is one of the options for receiving the latest treatments.
Reduce time constraints
There are many clinical trial/studies that do not require hospitalization and require only monthly or multiple visits to the hospital.
Reduce the economic burden
You will be compensated for the time and financial burden associated with participating in a clinical trial.
Demerit
Risk of side effects
Just like any other medicine, there is a possibility of side effects with investigational drugs. We will proceed with great care to ensure safety, but if any problems do occur, compensation is available.
Restrictions on daily life
You may be required to undergo more examination and visit the hospital more frequently than usual. Additionally, you may be asked to keep daily records, which may impose some restrictions on your daily life.
Related information
What is a food and daily necessities clinical study?
Flow of participation
FAQ