There are many reasons why people decide to participate in clinical trials:
Getting early access to new treatments that are not available outside the clinical trials setting
Access to expert medical advice from the study doctor and other members of the research team
Gaining a greater understanding of the nature of cystic fibrosis
Regular, detailed health check-ups
Results from the study may help others in the future
It should be noted that many clinical research studies have a placebo group. However, most studies will follow on to open label where you will receive the active drug.
What is a clinical trial?
A clinical trial is a scientific study, or an organised test of medicines and new treatment options, involving patient and non-patient human volunteers. Clinical trials confirm whether medicines are safe and effective to introduce as new treatments for a particular disease or condition.
Clinical trials may also be used to determine whether an existing medicine can be safely and effectively used for other diseases and/or conditions.
Why are clinical trials important?
Clinical trials help us to determine if a promising new treatment is safe and effective, as well as giving us a better understanding of the current standard treatment. This can improve patient care and outcomes by identifying a more effective treatment and/or lessening the side effects of treatment.
Clinical trials help change and shape treatment practices to improve the symptoms of cystic fibrosis and patient comfort throughout national and international communities.
Who can participate in a clinical trial?
All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results.
The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria".
These criteria are based on such factors as age, gender, CF genotype, previous medical history and other medical conditions.
Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants.
It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.
Will I be paid?
No, you will not be paid to participate in a clinical research study. You may, however, be reimbursed your travel costs and associated out of pocket expenses.
Please speak to your study coordinator about study reimbursements as they will vary from site to site.