BECOMING A VOLUNTEER

A clinical trial is a medical research project. It is carefully designed to learn more about a new treatment. All clinical trials are conducted in accordance with the Declaration of Helsinki and ICH/GCP Guidelines. Healthcare Authorities, such as Ethics Committees are involved in the clinical trial process to ensure patient safety.

Clinical trials have the potential to:
• Lead to new or better treatments
• Lead to improved quality of life
• Provide new medical information

Why Should You Participate in a Clinical Trial?
You may get involved in a clinical trial because you are suffering from a disease for which a safe and effective treatment does not currently exist. Or you may join a clinical trial hoping to improve your medical condition and/or quality of life. Or maybe you simply want to help in the advancement of science.

If you are considering participation in a clinical trial, we encourage you to discuss any questions or concerns you may have with your doctor. Your decision is voluntary and should be based on personal needs and interests.

Making the Decision to Participate in a Clinical Trial
By taking part in a clinical trial, you are contributing to the development of better treatments which may help others in the future. Choosing to participate in a clinical trial is an important personal decision. There is no obligation on your part to participate. Your participation will not influence how your health care provider treats you.

Your Participation is Confidential Your personal and medical information that is collected for the trial is stored in a way that your identity always remains confidential.

What Happens During a Clinical Trial? You will be asked to read and sign an informed consent form before your participation begins. This is a detailed document explaining all aspects of the trials. Before making this important decision, each participant will be given a full explanation of the clinical trial by the doctor, including:

• Whether the clinical trial is right for you.
• The possible benefits and risks.
• Your rights and responsibilities as a participant.
• Tests and examinations that may be required, such as having a blood sample taken or blood pressure measured.
• Whether or not the trial design includes a placebo.

Taking part in a clinical trial may provide the opportunity to:

• Use a new medicine only available within a clinical trial.
• Receive specialized/focused medical care associated with the clinical trial by a medically qualified doctor.

On the other hand, the following may happen:

• The trial medicine may not be of benefit to you.
• Your visits to the doctor may need to be longer and more frequent.
• You may experience unwanted effects from the trial medicine.

What Happens After a Clinical Trial?
After clinical trial participation has ended, the doctor may discuss future treatments. All of the information that is collected during the clinical trial will be studied and analyzed to learn more about the new medicine or treatment. The information collected will be sent to the regulatory authorities for review and approval. Upon approval, the medication may be made commercially available to patients.

Your Safety is Our Top Priority
Your safety is the number one priority in a clinical trial, and your condition will be closely monitored. Therefore, your doctor:

• Will ask you to take your trial medication as prescribed and to attend all your scheduled visits.
• It is imperative that you provide accurate information about your medical history.
• Needs to know about any changes in your condition no matter how minor they may seem to you.
• Will tell you about any new information that may affect your participation in the clinical trial.

You have the right to leave the clinical trial at any time and for any reason, and this will not affect the medical care you receive from the trial doctor.