Clinical research studies involve testing investigational study drugs on people living with a particular condition. All investigational study drugs have to be tested before they are allowed to be used in medical care. To begin with, investigational study drugs are tested in a laboratory on animals. Later, clinical research studies take place to understand how these investigational study drugs can affect people. The BEACON-CF clinical research study is taking place in people.
The study drug in this clinical research study is called investigational because it is not yet approved for treating cystic fibrosis by health authorities, such as the United States Food and Drug Administration (FDA), the European Medicines Agency (EMA) in the European Union, or health authorities in other countries. The BEACON-CF clinical research study will help researchers to understand how safe the investigational study drug is, and how it may help the treatment of cystic fibrosis for the future.
All clinical research studies must be reviewed by regulatory authorities to make sure everyone who chooses to take part is treated safely and fairly. This review is carried out by health authorities and groups called institutional review boards and research ethics boards, which are external groups that are not affiliated with any clinical research studies. This means the review is as unbiased as possible, and helps make sure all clinical research studies uphold the same safety and ethical standards.
Without this review, clinical research studies would not be able to take place. There may be risks in taking part, either from the investigational study drug or device, or the tests involved, and these are explained in detail by the study doctor before you decide to take part. You will always have the option to ask questions about any of the tests or procedures involved in the study, and you can stop taking part in the study at any time.
Clinical research studies can take place in many locations, including hospitals, universities, doctors’ offices, and community clinics. If you decide to take part in the clinical research study, you will receive information regarding the clinical research study location.
If you are interested in the BEACON-CF clinical research study, click here to find out where it is taking place near you.
If you meet the criteria and decide to take part, the study doctor will share more information about the number of visits and the time expected from you during the study.
The length of time you participate in the clinical research study will be approximately 28 weeks.
Around 9 people will take part in this clinical research study, and additional people may be able to take part.
Your responsibilities for the BEACON-CF clinical research study will be explained to you by your clinical research study team. Some of your responsibilities will include:
There are some possible risks to taking part, which may occur from the investigational study drug or investigational device, or from some of the tests. Before taking part, you will be provided with an Informed Consent Form that describes the full details of the risks involved. The study doctor will also discuss risks with you and will answer any questions that you may have about the clinical research study.
It is not expected that you will experience a direct benefit due to participating in this clinical research study. However, the information from this clinical research study will help to advance the knowledge of cystic fibrosis and how it is treated, and may help people living with cystic fibrosis in the future.
You can stop participating in the BEACON-CF clinical research study at any time by informing your study doctor, this is called the right to withdraw. The study doctor may also stop you from taking part at any time for various reasons. Before taking part, you will receive an Informed Consent Form which provides further details on your right to withdraw.
You will be compensated for your study-related time and reimbursed for expenses needed to participate in the clinical research study, like transportation, accommodation, and meals. You will be given full details as to how much you will be reimbursed by a member of the study team.