What is a Clinical Trial?
We, Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics, strive to provide the proper knowledge on clinical studies to the general public. We are now recruiting volunteers who can participate in the clinical studies （clinical trials） conducted by Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics.
If you are interested in participating in the clinical study （clinical trial） as a Clinical Research Institute Volunteer, please read Contents on this website before registering yourself for the Clinical Research Institute Volunteer Panel through the webpage “Registration for the Clinical Research Institute Volunteer Panel”.
What is a Clinical Trial?
Clinical study is a test to assess the effectiveness and adverse effects of “candidate drug” in humans. “Clinical trial” is a kind of clinical study conducted for the particular purpose of obtaining government （Ministry of Health, Labour and Welfare） approval as a “medicine”.
The following flowchart outlines the steps of developing a new medicine. Medicines we currently use have also been developed through the same process and received government approval before being used in general clinical practice.
Phase 1 Trial
A study is given to a small group of healthy adults （including patients） to see whether the “drug” is safe or not. Also, the study explores the amount of time the drug takes to be absorbed into the body and excreted.
Showa University Clinical Research Institute for Clinical Pharmacology and Therapeutics （“the Center”） has 44 beds dedicated for clinical research.
Phase 2 Trial
A study is given to a small group of patients to see how effective the drug is （effectiveness）, what kind of adverse effects occur and how often （safety）, and how the drug should be used. （dosage, period and frequency of administration, etc.）
Phase 3 Trial
A study is given to a large group of patients for the final confirmation of the effectiveness, safety and usage of the drug. Clinical trial is conducted in accordance with the rule determined by the government （GCP=Good Clinical Practice）. The issues such as protection of patients’/healthy volunteers’ human rights and safety are thoroughly examined at the institutional review board, and all the clinical trials are conducted with the approval of the director of the hospital.
Cooperation of many patients/healthy volunteers is critical for the development of medicines.
Glossary
Clinical Study （Clinical Trial）
Clinical study is intended to thoroughly investigate whether or not the “candidate drug” is really safe and effective in human beings. Among them, clinical trial is one type of clinical study in which the national government （Ministry of Health, Labour and Welfare） evaluates the obtained data （effectiveness, side effects, etc） and determines whether the drug can be used as a pharmaceutical product.
Post-marketing Study
After the drug is approved by the national government （Ministry of Health, Labour and Welfare） as a pharmaceutical product, post-marketing study is conducted while the new product is used by large number of people at general clinical practice, aiming at collecting the information mainly on product safety such as new or few side effects or interactions with other drugs.
Declaration of Helsinki
Formally called “Ethical Principles for Medical Research Involving Human Subjects”, this statement articulates ethical principles involved in medical research defining that the well-being of the individual research subject must take precedence over all other interests for science and society. Human rights are fully respected in conducting clinical trials in accordance with the Declaration of Helsinki.
IRB: Institutional Review Board
Institutional Review Board （IRB） is an organization that monitors and reviews issues such as human rights and safety of the persons who enroll in clinical trials and the scientific nature of the trial. The board members include not only the medical/dental/pharmaceutical professionals from the hospital but also those who are lay persons or who do not have stakes in the hospital.
Informed Consent
Written informed concent needed for clinical trial participants to make decision such as the purpose and procedure of the trial, potential benefits （efficacy of treatment） and risks （adverse effects） will be fully explained. After the participant fully understands the written information, he or she decides whether or not to enter the trial at one’s own free will, and gives official consent by signing the document.
CRC: Clinical Research Coordinator
Clinical Research Coordinator （CRC） is responsible for facilitating reliable trials and researches under the auspices of the investigators （doctors）. In Japan, the term frequently refers to “Clinical Trial Coordinator”, but recently they are also called “Clinical Research Coordinator”.
GCP
GCP stands for Good Clinical Practice, which articulates the standards to be followed by medical institutions, doctors and pharmaceutical companies in order to conduct clinical trials reliably, ethically and scientifically.
Investigational Product
Investigational products include test drugs and comparator drugs. A test drug contains an ingredient which is expected to have benefits for the purpose of the trial, and a control drug contains different ingredients than the test drug. Control drugs include a pharmaceutical product already available on market which has the same effect/efficacy as the test drug, and a placebo which has no pharmacological effects. （The appearances is indistinguishable from that of the test drug） Subjects are randomly assigned to receive either of the investigational products （test drug or control drug） to evaluate the effectiveness and safety of the products while avoiding the selection bias between investigators and subjects.