About clinical trials and SMOs
What is a Clinical Trial?
Clinical trials are indispensable for the introduction of new drugs to the market. In order for a new drug developed by a pharmaceutical company to be used and sold at medical institutions and pharmacies, it must be approved by the government (Ministry of Health, Labor and Welfare).
In order to obtain government approval, the drug must be taken by healthy people or patients who are expected to benefit from the drug, and its efficacy and safety (presence or absence of side effects, etc.) must be examined beforehand.
The trials designed to obtain approval for a drug on human subjects are called clinical trials.
The drugs we use today were all created with the cooperation of many people. Participation in clinical trials is also for the benefit of patients who are waiting for the birth of new drugs.
Clinical Trials at Medical Institutions
Clinical trials for new drugs are conducted in phases 1 through 4, of which phases 2 through 4 are conducted on patients.
Clinical Trial
- Phase 1 trials：
- To confirm the drug's side effects, the drug is administered to healthy subjects.
- Phase 2 studies：
- A small number of patients are dosed with the drug to investigate its therapeutic effect and safety.
- Phase 3 studies：
- A large number of patients are dosed with the drug to confirm its therapeutic effect and safety.
Approval is granted and a new drug is born.
- Phase 4 studies：
- After marketing, data on efficacy and safety will be collected from a large number of patients who have received the medication.
Benefits of Participating in Clinical Trials
By cooperating in a clinical trial, you can be among the first to take drugs developed through the latest research. In addition, you will undergo more detailed examinations than in general medical care, leading to a more detailed understanding of your own medical condition. Above all, we believe that it is a very noble act to be able to give birth to new drugs for the next generation by contributing to society through participation in clinical trials.
Safe and Secure Clinical Trial Environment
The medical institutions that conduct clinical trials are provided with medical facilities and highly specialized medical staff as stipulated by the "Ministerial Ordinance Concerning Standards for Conducting Clinical Trials on Drugs," and are able to provide appropriate treatment and procedures even in emergency situations. Personal privacy is strictly protected and a firm ethical system is in place.
Clinical Trial Process
If you wish to participate in a clinical trial and meet the conditions for clinical trial participation, you will receive a detailed explanation of the purpose of the treatment, the expected effects and side effects, and the duration of the treatment. It is especially important that you give your consent with full understanding (informed consent) because of the research aspect of a clinical trial. It is the patient's own free will to decide whether or not to participate in a clinical trial. You will never be forced to participate in a clinical trial, nor will you be disadvantaged by refusing. Of course, you can withdraw from a clinical trial at any time, even after it has started.
Trusted Clinical Trial Support System
In order to ensure that patients fully understand and agree with our services and participate in clinical trials with peace of mind, we assign specialized clinical trial coordinators, called CRCs, to medical institutions, so that patients can feel free to consult with us at any time about any concerns or questions they may have. Clinical trials are conducted with the utmost respect for the human rights of the patients who participate.
Points to Keep in Mind When Participating in Clinical Trials
While there are many benefits to participating in a clinical trial, there are also several things to keep in mind. For example, you may be required to come to the hospital on a certain day, or you may have to keep a record of the doses you take, which may be troublesome. Also, due to the nature of the study, there is a possibility of rare and unexpected side effects. In addition, you may be taking placebos, which are fake drugs that have no therapeutic effect.
Request for Participation in Clinical Trials
Although medical science has made remarkable progress, there are still some diseases for which there is no cure. In order to overcome such diseases, research for new drug development is being conducted day and night. However, clinical trials are inevitably necessary for new drugs to be born. For the sake of tomorrow's medical care, we would like to ask as many patients as possible to participate in clinical trials.
What is a SMO?
SMO stands for Site Management Organization. By supporting the operations of medical institutions conducting clinical trials, we reduce the burden on clinical trial sites and improve the quality and speed of clinical trials through the expertise of a specialized organization.
Growing Expectations for SMOs
In recent years, the environment surrounding clinical trials has undergone major changes. In particular, the "Revised GCP (Good Clinical Practice)" came into effect in 2003, and the way of new drug development appropriate for the new era is now required. We support the clinical development of new drugs that are more effective and safer by focusing on the human rights and safety of trial subjects to the maximum extent possible, an ethical principle based on the Declaration of Helsinki. To accomplish this important task imposed on clinical trials and to promote the hurried development of new drugs, many expectations are now placed on SMO companies specializing in clinical trials.
Benefits of using SMO
On behalf of the clinical trial site, we prepare complicated procedural documents, operate and manage the Clinical Trial Review Committee, and so on. We can ensure smooth implementation of clinical trials by providing full support for compliance with relevant laws and regulations and various clinical trial operations. In addition, we provide support for the appropriate progress of clinical trials by negotiating with pharmaceutical companies that request clinical trials.