What is a clinical trial
“Clinical trials” has a long history.
Medicines and treatments can’t be offered to medical institutions or pharmacies without approval of a regulatory agency. A clinical trial is a type of research that conducted with the cooperation of healthy volunteers or patients in order to receive approval from the regulatory agency.
Clinical trials are not limited to new drugs. If a drug is used overseas already, a clinical trial is still needed before it can be used in Japan. Maybe the word of “clinical trials” is not so familiar to you, but it is not something new. It has a set of well-established system with a long history, and developed with the progress of modern medicine.
A clinical trial is a necessary procedure to release a new drug
The ingredients of the medicine are derived from chemical synthesis, unknown substances such as bacteria in plants or soil, marine organisms and so on. In order to confirm effectiveness and safety, the substances will be tested by repeating animal experiments.
However, since these are something used on the human body, it is still necessary to evaluate the efficiency and safety on humans as a “drug candidate (study drug)”.
Clinical trials are widely conducted in developed countries
Clinical trials are conducted in all developed countries. The globally uniform standards which emphasize the accuracy of clinical trials and respect for human rights have been formed. In developed countries where volunteerism has developed, there is a growing awareness that “clinical trials” is a necessity for society, similar to “donating blood”.
Now we hope "clinical trials" could be understood more
Assuming that there are 100 new drugs have been developed in the world, 80-95 of them are already used in many developed countries whereas only 15-20 of them are used in Japan. The present situation in Japan is that people are not aware of the "clinical trials" and refuse to cooperate, thus the birth of new drugs is delayed.
By increasing the number of people who understand "clinical trials" could speed up the development of new drugs which would be provided to the patients suffering from illness in the world.
Development process of a new drug
In the process of a new drug development, it takes the longest time for clinical trials.
Let's look at what clinical trials do in the process.
Developing a new drug may take 10 years or more. During the long years, what role does the “clinical trials” play in the development? Let's check and understand it by according to the following explanation.
Basic research
(Drug discovery)
(Drug discovery)
In this stage, researches will be carried out in order to find substances which can be used in drugs from plants, scientific substances, and microorganisms
Preclinical studies
Animal testing is conducted to assess whether the substances are safe and effective. Before starting a clinical trial, the efficacy and safety must have been confirmed in the animal testing.
Clinical trials
Phase1 trial
Aim to evaluate safety using a few healthy adults as research subjects.
Phase2 trial
Aim to assess the efficacy and safety of the candidate drug with the cooperation of a small number of patients.
Phase3 trial
In order to confirm the efficacy, safety and usage, the new drug will be compared the difference with existing drugs.
New Drug Application
Review / Approval
Review / Approval
The regulation and control of new drugs in Japan has been based on the PMDA (Pharmaceuticals and Medical Devices Agency). In order to be recognized as a "drug", the application of a new drug must be approved by PMDA. The review process is stringent. Once the efficacy and safety is reviewed, a license will be issued.
Post-marketing surveillance /
Post-marketing clinical trials
Post-marketing clinical trials
After approved by PMDA, the new drug can be manufactured, sold and used. Information on efficacy and safety will be collected and analyzed continually while the drug used by patients.
In the process of a new drug development, it takes the longest time for clinical trials.
Clinical trials are so important that always be treated with the utmost caution.
Advantages and disadvantages of participating in clinical trials
Clinical trials are carried out with the volunteers who participate in voluntary action. Therefore, please carefully judge the merits and demerits of participating in clinical trials.
Advantages
- ●You can receive treatment with new drugs quickly. You can receive treatment with new drugs quickly, such as a promising drug slowed unprecedented efficacy or a drug is already used overseas.
- ●You can receive more detailed treatment. As there is aspect of examination, you may have more blood tests, scans or other cancer tests more than usual treatment. So you would know in detail about your disease state.
- ●You can receive reduced treatment costs During the trial, the drug company will bear part of the costs of medicine and testing.
- ●A portion of transportation expenses will be paid. To reduce expense burden for visiting the hospital, you can receive transportation expenses assistance to some extent.
- ●The doctor in charge will consult consistently The clinical investigator (maybe more than one) will consult consistently. And there is no need to consult with other than clinical investigator.
- ●You can consult carefully A Clinical research coordinator (CRC) will respond kindly to the questions and consultations regarding clinical trials in general.
- ●Participating in a clinical trial is a social contribution. You can contribute to society by participating in a clinical trial while thinking about "I want to contribute for people suffering from illness" or "I want to leave a better medicine for the next generation".
Disadvantages
- ●You may have to visit the hospital more often and longer than usual In order to confirm the efficacy and safety of the new drug, the number of visits and examinations may be more than general treatment.
- ●You may be asked for various cooperation You may be asked to take medicine on time, and record your physical condition. Also, depending on the content of treatment, you may be asked to restrict exercise or diet.
- ●The risk of side effects wouldn’t be completely denied. New drugs may cause unknown side effects. Of course, you should take them with sufficient safety in clinical trials, but the risk of side effects can’t be completely ruled out.
- ●Clinical trials must be taken at designated hospitals only. Because clinical trials can only be performed at a designated hospital, so even if the patient’s will, the treatment couldn’t be conducted outside the designated hospital. And for safety reasons, you should also consult your clinical investigator if you want to use over-the-counter medicine.
The rules of clinical trials
Informed consent
When a subject decides to participate in a clinical trial, he (she) should be fully explained about the clinical trial from all sides.
If the subject understands and expresses intent to participate in the clinical trial, he (she) should confirm it by written documents.
Informed consent is validated by a signed and dated consent document from the subject and the clinical investigator.
The contents that must be explained in a clinical trial are defined in GCP (Good Clinical Practice). And “The contents should be interpreted as simple as possible.”, “The questions from the subject should be answered fully” are also required in GCP.
Descriptions
Such clarifications are described in the consent statement.
- Carry out the clinical trial for the purpose of experiment
- Purpose, method, period of the clinical trial
- Name, position, contact information of clinical investigator
- Expected effects and harms of investigational drugs
- Other treatment issues
- The participation can be canceled any time you want
- Subjects will not receive any disadvantageous treatment if they refuse or withdraw the participation.
- Monitors *, auditors, and IRBs can view the source data directly based on protecting subject's personal information.
- Confidential information about subjects is protected.
- Contact information of the medical institution in the case of occurrence of health hazards, and necessary treatment will be conducted.
- Matters concerning the guarantee of health hazards, and nondisclosure agreement.
- Necessary matters concerning clinical trials.
* The abbreviation of clinical trial monitors. The person who monitors and confirms the trial is properly conducted or not during the clinical trial.
What does a clinical research coordinator (CRC) do?
A Clinical Research Coordinator (CRC) is a person who assisting the process of clinical trials at medical institutions.
Descriptions
Such clarifications are described in the consent statement.
- We will explain in more detail about drugs and schedules of the clinical trial after you received explanations from the doctor.
- We will respond to your anxious feelings and questions about clinical trials.
- We will arrange and inform you of the date and examination schedule before you visit hospital every time.
- Before you get an examination, we will talk to you about the changes in physical condition and whether there are side effects.
- We will assist in your examination, and explain how to use investigational drugs etc.
- In order to conduct a clinical trial safely and smoothly, we will contact and coordinate with doctors, hospital staffs and pharmaceutical companies.
Clinical trial coordinators (CRC) can protect human rights of patients (subjects), promote clinical trials smoothly, pay attention to security and privacy and respond appropriately.
About participating in clinical trials
ASBO is a website that guides clinical trials as one of treatment options under the motto of “Building tomorrow’s healthcare”.
This website will provide an opportunity to receive the latest treatment with safe and secure support.
