Q1:Can anyone participate in clinical trials?
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 doctor’s health check and examination at the clinic where the trial is to be conducted. This determines whether the volunteer matches the criteria and objective of the trial. After the health check a decision will be made regarding whether the volunteer can participate.
Q2:What kind of new drugs are tested at clinical trials?
The novel drugs tested at clinical trials are substances that have passed a fixed safety and efficacy evaluation after repeated, long-term testing performed by a pharmaceutical manufacturer. While novel drugs are expected to have new beneficial effects, the possibility of side effects is also a concern. This is why careful attention is always paid to subjects when such drugs are administered.

Q3:Are clinical trials safe?
It is necessary to exercise regular caution concerning the risk of side effects, even with drugs already on the market.
P-one Clinic has adopted the following approach to ensure clinical trial safety:
•We prioritize safety and make sure that subjects can always consult with the doctors in charge, trial coordinators and other key supervisors.
•We have adopted a system that allows us to take the appropriate measures immediately if side effects occur.
•We have established an Institutional Review Board that investigates whether trials should be taken on by the clinic and carries out regular safety checks while trials are in operation.
•In order to maintain safety and protect human rights, all trials are planned and operated in accordance with the regulations of Good Clinical Practice (GCP).
In this way, the clinical trials at P-one Clinic are conducted on the basis of multiple safety systems.
Q4:Does it cost anything to participate in clinical trials?
All the examinations conducted during the period the trial drug is administrated are free. In most cases the trial drug is provided free of charge by the drug manufacturer. Moreover, we pay volunteers a fixed amount to reduce the burden of transportation expenses when commuting to the clinic. For details, please contact the clinic at the time of your registration or ask the trial coordinator.
Q5:Can I participate at any time?
Each trial is carried out for a fixed period of time according to a particular plan. The set washout period between trials varies. In some cases participation in a trial is not possible until a fixed amount of time has passed since the previous trial. Please inquire about the washout period for any trial you might wish to participate in.
Q6:What are the advantages of participating in clinical trials?
The basis for participation in clinical trials is the subject`s desire to volunteer out of their own good will. You can receive examinations from medical specialists and a detailed explanation of your progress during the trial. Moreover, in some cases you can try the newest drugs before their release on the market.
Q7:What are the disadvantages?
Each subject`s condition is unique, and disadvantages can include the following:
•You may have to put aside your spare time to commute to the clinic and take examinations.
•You will have to obey the trial rules and precautions.
•If necessary you may have to make a record of taking the drug.
•Depending on the subject, some drugs may be ineffective or have unexpected side effects.
The doctor in charge will explain such matters, so please participate with understanding of the risks.
Q8:If I am admitted into a trial, what steps are required?
You will need to attend a pre-trial information session/health check, and listen to a presentation from the head doctor/trial coordinator, before signing the trial participation consent form. The consent form also includes information about the trial in most cases.
Q9:Am I allowed to drop out of the trial even after signing the consent form?
Yes. Trial participation is the voluntary decision of each subject so you can inform the head doctor and withdraw at any time. You will not receive any disadvantageous treatment in the case of cancellation.
Q10:Will my privacy be protected?
The various kinds of data collected at clinical trials become the source material for applications that are submitted to the Minister of Health, Labor and Welfare (MHLW) for approval to manufacture and import medicine. The medical site (P-one Clinic) reports the trial data to drug manufacturers and other related organizations, but no personally identifying information whatsoever is included. In some cases MHLW officials and drug company supervisors will access personally identifying information after completion of the trial, but even in this case, all accessing parties are are legally obligated to keep all personally identifying data confidential and must never leak it externally.
Q11:Are there are any rules we need to follow during clinical trials?
There are a number of rules that subjects will be asked to follow in order to ensure their safety and to help us obtain reliable data. These rules concern the time and frequency of drug dosing, the date of clinic visits, drug dosing records and so on. The head doctor and trial coordinator will provide a concrete explanation of all the rules.
Q12:Is there anything we need to be careful about during daily life?
Depending on the type of illness and objective of the trial, subjects may be asked to take precautions concerning their daily lifestyle. For example, there may be restrictions on smoking, alcohol consumption, nutrition, amount of exercise and so on.
Q13:What kind of examinations are performed during clinical trials?
Clinical trial examinations are performed to monitor the health of subjects, and are used as data to check the effectiveness and evaluate the safety of medicines. The type of examination varies depending on the trial objective, the medicine, and other factors.
Q14:Am I allowed to withdraw part-way through the trial?
If you feel you are unable to continue the trial for some reason, you can talk to the head doctor and withdraw at any time. Abruptly discontinuing a trial drug can have negative effects in some cases, so please be sure to withdraw after consulting with the head doctor.
Q15:Are clinical trial volunteers uncompensated?
Clinical trial volunteers are paid a certain amount as compensation for participation. For your cooperation in abiding by lifestyle restrictions, as well as bearing the costs required for commuting to the clinic and putting aside your time, we offer remuneration in accordance with a fixed standard. As such, participation in a clinical trial is different, for example, from a part-time job contract.

Haven’t found what you’re looking for? You can find more information in this Q&A or send us an email, and we’ll be happy to assist you further: info@tokyo-clinical-trials.com

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