What is a clinical research study?
Clinical research studies are used to show if/how an investigational medication works and to find out if it is safe. They can also be referred to as clinical trials.
Clinical studies are run by qualified healthcare professionals. The doctors and other healthcare providers are responsible for the study-related care of the people that participate (or enroll) in these studies. Clinical trials are a mandatory part of the process that leads to approval, which is required before a drug can be marketed.
Independent committees (called Institutional Review Boards or IRBs) are made up of medical and nonmedical people, who also watch over clinical research studies, to make sure that the people who enroll are properly and adequately informed and consent prior to study participation.
Why are clinical trials conducted?
Clinical trials are essential to the development of new interventions (drugs, procedures, devices etc) that strive to help people to live longer and with less pain or disability.
They help researchers to understand what does and doesn’t work in humans that cannot be learned in the laboratory or in animals.
Clinical trials also help doctors decide if the side effects of an investigational treatment are acceptable when weighed against the potential benefits.
Clinical trials are also required by the health agencies for new interventions prior to being prescribed and used by healthcare professionals for treatment of patients.
What is a bronchoscopy?
A bronchoscope is a device (scope) that lets the doctor see the inside of your lungs. The scope is a made from a thin tube with a light at the tip which is passed through your mouth or nose, then into your lungs. It is through this scope that doctors can see the inside of the airways, take tissue samples or rub a brush alongside of your airways.
There are risks associated with bronchoscopies and your doctor will review those in details with you.
What is an investigational medication?
An investigational medication is what is being studied to see if airway inflammation improves while taking it. The drug is not yet approved for general use by regulatory authorities.
Why should I join a clinical research study?
Thousands of people volunteer to participate in clinical trials every year. The reasons for participation vary, but all of them help to advance medicine. Some reasons include:
- Medical supervision. Some people have a disease for which there is no approved treatment. They might join a clinical trial in the hopes of receiving an investigational medicine.
- Contribute to future treatments. Many participants wish to help future patients. This has been reported by both patients and healthy volunteers.
- Help improve the lives of others. Some people participate with the hope of helping others. The investigational medication could benefit other patients and, in some cases, save lives.
Who can participate in a study?
Every clinical trial has a set of criteria that study participants must meet in order to participate, including agreeing to sign an informed consent form and HIPAA authorization.
What is an informed consent?
Before deciding to participate in a clinical study, potential participants will go through a process called "informed consent". This is designed to help to learn more about the clinical trial before deciding whether or not to participate.
Potential participants are given detailed information about the study. This includes:
- the purpose,
- the possible risks,
- the potential benefits,
- how long it will take,
- what procedures are required, and
- whom to contact with any questions or issues.
Once potential participants have no further questions, the document is signed to confirm the decision to participate. An informed consent is designed to protect the study participant. It is not a contract. A participant can ask questions or stop participating for any reason and at any time, even before the study is over.
What is an open label study?
Both the study participant and study doctor will know what investigational medicine the patient is receiving.
What type of study-related medical care is provided during the study?
All study-related medical care related to the study is provided. There is no insurance required to participate. A full schedule of participation activities will be shared with the study participant at the beginning of the study.
Study participant may receive additional study related compensation for time and effort, where permitted. Reimbursement for travel expenses (airfare, lodging, meals) may be provided.
Is it safe to participate in a clinical trial?
All clinical trials have possible risks, some of which are known before the study starts. Before deciding to participate, the known study risks will be explained. Study participants are closely monitored during the study.
While side effects may occur with any investigational medication being studied, the safety and well-being of study participants are top priorities for the sponsors, doctors, nurses, and research professionals who conduct clinical trials.
Study participants can decide at any point to end participation.
Can I speak with someone if I have questions?
Yes, after you complete the online questionnaire and give permission to be contacted, a study representative will make contact with you. You can ask questions at any time before deciding to participate to the study and during study conduct. The study doctor and all site staff will be available to address your questions.