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Clinical trial participation means helping medical research to ensure that new drugs under development are effective and safe for patients who might use them once they are on the market. Every clinical trial is therefore a new study that may involve risks. InoKura is committed to fully informing volunteers of any adverse effects and potential risks that may arise during the clinical trial in which they wish to participate. Before the screening visit (the very first visit to select volunteers), we provide an informed consent form. This document must be read and accepted by the volunteers before going any further in the recruitment process. The form contains all essential information about the clinical trial. Its sole purpose is to enable volunteers to understand the implications of trial participation and to help them to make an informed decision. Should volunteers still have questions after reading these documents, they are free to ask any member of our medical team.

Volunteers are free to withdraw their consent from a clinical trial at any time.

If a volunteer withdraws consent during a trial, compensation will be prorated for the time spent in the trial.

If a volunteer experiences any adverse effects, whether related to the trial medication or not, he/she will be promptly examined by the study doctor. If required by the volunteer’s state of health, the doctor will carry out additional tests to establish a diagnosis and treat the symptoms as quickly as possible.

Here is a list of things to bring if you are selected to participate in a clinical trial involving hospitalisation:

• Toiletries (toothbrush, toothpaste, shower gel, deodorant, etc.)
• Bath towels
• A change of clothes
• Something to keep you busy (books, magazines, a tablet, a computer, a mobile phone, video games, board games, etc.)

Drinks, meals and snacks are served on the ward, so there’s no need to bring them with you. We also ask you not to bring any medication with you when you are hospitalised on the unit: we provide you with all necessary and authorised medication.

During hospitalisation, the days are based around various examinations carried out according to a precise schedule that our team strictly adheres to. This is why volunteers are sometimes asked to stay in their rooms at certain times of the day, most often in the morning. Some examinations require volunteers to lie down or sit up for a few minutes before they are carried out. The nursing staff take care to explain to volunteers how their days at the hospital will be spent so as to ensure that they go as smoothly as possible. During periods when there are gaps between examinations, volunteers are free to move around the unit and occupy themselves as they wish.

Volunteers who are selected to join a clinical trial will receive financial compensation. The compensation amount is specific to each trial, and varies from a few hundred euros to 4-5,000 euros. It is assessed on the basis of study-associated demands (number of days of unit hospitalisation, number of outpatient visits, examinations carried out, etc.).

Compensation must be approved by the Ethics Committee overseeing the study.

Under no circumstances is financial compensation linked to risk. In addition to financial compensation, volunteers will receive a full medical check-up before joining the study and be compensated for the time spent on these examinations.

Drug interactions should be avoided to protect the health of the volunteer and trial integrity. The contraceptive pill is generally accepted. For other drugs, it depends on the trial in which the volunteer wishes to participate.

An Ethics Committee is a European body that ensures compliance with Good Clinical Practice (GCP) and the protection of participants’ rights. Before study start-up, each trial must be approved by a European Ethics Committee. This committee must take into account a number of factors, such as the relevance of the trial and its design, the protocol, the suitability of the investigator (i.e., the person responsible for conducting a clinical trial at a site) and his/her collaborators, and the quality of the facilities. This committee guarantees the smooth running of the study so as to ensure volunteers’ safety.

It is possible to take part in several successive clinical trials, but not simultaneously. In fact, some of our volunteers take part in several trials per year. Participation in different clinical trials is subject to a waiting period ranging from 1 to 3 months, depending on the type of previous trial and rules established by the trial partners.

No. Whether for a screening appointment, hospitalisation or an outpatient visit, the team’s doctors cannot legally cover your absence from work with a medical certificate. However, a certificate of attendance may be issued by one of our doctors.