Q&A With Dr. Furihata

Q1: Can anyone participate in a clinical trial?
Q2: What kind of drugs are tested at clinical trials?
Q3: Are clinical trials safe?
Q4: Does it cost anything to participate in a clinical trial?
Q5: Can I participate at any time?
Q6: What are the advantages of participating in a clinical trial?
Q7: What are the disadvantages?
Q8: What happens if I am invited to a screening?
Q9: Am I allowed to drop out of a trial even after signing the consent form?
Q10: Will my privacy be protected?
Q11: Are there are any rules we need to follow during the trial period?
Q12: Is there anything we need to be careful about in daily life?
Q13: What kind of tests/examinations will I take?
Q14: Am I allowed to withdraw partway through the trial?
Q15: Are clinical trial volunteers compensated?

Q1: Can anyone participate in a clinical trial?

The first condition for participation in a clinical trial is to meet the basic recruitment criteria. Those who meet these criteria will be invited to a screening (health check and information/consent session) at the clinic or hospital where the trial is to be conducted. Based on the result of the screening, a decision will be made regarding whether the volunteer is eligible to participate in the trial.

Q2: What kind of drugs are tested at clinical trials?

The drugs tested at clinical trials can range anywhere from common medicines that have been taken by patients around the world for many years to novel drugs that are still in the early stages of research. Whereas the effect of common medicines on a wide range of people is usually well understood, novel drugs will have only undergone extensive laboratory and animal testing to determine their safety and efficacy. Whatever kind of drug is being tested, the possibility of side effects is a concern. This is why volunteers are always carefully monitored and measures are taken to ensure their safety.

Q3: Are clinical trials safe?

It is always important to exercise an appropriate degree of caution regarding the risk of side effects, even with drugs already on the market. At P-One Clinic, we recognize such risks and treat volunteer safety as our number one priority.

To protect the human rights of volunteers, all our trials are planned and operated in accordance with the internationally recognized standards of Good Clinical Practice (GCP). This means that they must first be approved by an independent ethics body called an Institutional Review Board, which also carries out regular safety checks once trials are in operation. Moreover, we have established a number of safety systems, ensuring that volunteers can always consult with our doctors, coordinators and other key staff, and allowing us to respond rapidly if any side effects are experienced.

Q4: Does it cost anything to participate in a clinical trial?

All examinations, screenings, and testing are conducted free of charge. For regular health checks, we pay volunteers a fixed amount to help cover their transportation costs and provide compensation for participation in trials. Amounts vary and details will be sent to members when invited to visit the clinic.

Q5: Can I participate at any time?

Trials are conducted on particular days according to a fixed schedule. Members who match the initial recruitment criteria will be invited to join screenings on specific dates. Those who have participated in another trial recently may be unable to participate until a certain amount of time has passed. The length of the washout period varies from trial to trial.

Q6: What are the advantages of participating in a clinical trial?

Volunteers should participate in clinical trials voluntarily, on the basis of their own good will. The frequent testing and examinations from medical specialists provides an opportunity to learn about your physical condition. The data gathered through your participation may help bring treatments to the patients that need them.

Q7: What are the disadvantages?

Each volunteer’s condition is unique and disadvantages may include the following:

• You will have to put aside your spare time to visit the clinic and complete the trial
• You will have to abide by the trial rules and requirements
• For some individuals, drugs may be ineffective or have unexpected side effects

The doctor in charge will provide a detailed explanation of the trial and volunteers will only participate with a full understanding of the possible risks.

Q8: What happens if I am invited to a screening?

Screenings include an information session where the head doctor will provide a presentation about the study and answer all questions.Volunteers will then decide whether to consent to participate in the trial. Those who consent will take a health check and examination. Those who pass the screening will be invited to join the rest of the study.

Q9: Am I allowed to drop out of the trial even after signing the consent form?

Yes. Trial participation is completely voluntary and you can inform the head doctor and withdraw at any time, even after the trial has begun. You will not receive any disadvantageous treatment if you decide to withdraw.

Q10: Will my privacy be protected?

The data collected at clinical trials become the source material for applications that are submitted to the Ministry of Health, Labor and Welfare (MHLW) for approval to manufacture and sell medicine. The medical site (P-One Clinic) sends reports containing trial data to the drug manufacturer and other related organizations, but no personally identifying information whatsoever is included. Sometimes MHLW officials and drug company supervisors will access personally identifying information after completion of the trial, but even in these special cases, all accessing parties are legally obligated to keep personally identifying information confidential and to never leak it externally.

Q11: Are there are any rules we need to follow during the trial period?

There are a number of rules that volunteers will be asked to follow so as to ensure their safety and to help us obtain reliable data. These rules concern the time and frequency of testing, dosing, the date of clinic visits and so on. The head doctor and trial coordinator will provide a detailed explanation of all the rules at the screening.

Q12: Is there anything we need to be careful about in daily life?

Depending on the target illness and objective of the trial, volunteers may be asked to alter their daily lifestyle. For example, there may be restrictions on smoking, alcohol consumption, certain kinds of food, strenuous physical activity and so on.

Q13: What kind of tests/examinations will I take?

Clinical examinations are performed to monitor the physical condition of volunteers, and to gather data used in evaluating the effectiveness and safety of medicines. Different kinds of tests are performed depending on the trial objective, the medicine, and other factors.

Q14: Am I allowed to withdraw partway through the trial?

If you feel you are unable to stay in the trial for some reason, you have the right to withdraw at any time. Abruptly discontinuing a trial drug can have negative effects in some cases, so we recommend withdrawing after consulting with the head doctor.

Q15: Are clinical trial volunteers compensated?

To help cover the costs associated with participation, including commuting to the clinic, putting aside your time, and abiding by lifestyle restrictions, clinical trial participants are provided with remuneration in accordance with a fixed guideline.