- Clinical trials are the best way to evaluate new therapies.
- Studies are highly regulated and must meet strict approvals.
- There is no obligation to take part in clinical trials.
- Your care & treatment will not be affected if you do not participate.
- You are free to withdraw at any stage.
We believe that every patient with PBC should have the opportunity, if appropriate, to take part in clinical trials. It may not always be possible for every person with PBC to take part, as some clinical trials have more restrictive participation criteria than others.
There are more clinical trials in PBC than ever before with more and more pharmaceutical companies exploring possibilities of their compounds to make a positive difference for PBC patients. The best way to evaluate new therapies, their benefits and side effects, is through clinical trials. In fact, the licensing of Obeticholic Acid (OCA) could only be made possible through clinical trials.
Despite great strides in recent years, there are still many unanswered questions about PBC: what causes the disease? how best to treat the condition and its symptoms? What is the cure? We can only answer these questions with research and that requires your help and support.
Current studies are exploring treatments for itch, looking for links between fatigue and cognitive impairment (or what patients often refer to as “brain fog”), and expanding our knowledge of the condition. Many patients, not only now but in future generations, would benefit from these cures being discovered.
The PBC Foundation recognises the importance of, and need for, well-designed clinical studies that will help with the diagnosis and outcomes of people with PBC. Developing new treatments for patients with any disease, PBC included, is never easy, and particularly for new drugs requires doctors to run clinical trials.
In the UK and other countries, research involving patients is regulated and the PBC Foundation is keen to encourage all those with PBC to support clinical studies, provided they are appropriately approved. It is important that all participants know there is no obligation to take part in clinical trials, and not taking part will not affect your care, but at the same time participation in such trials can help advance the understanding of PBC and help find better and more effective therapies.
Before you agree to take part in any research and sign the Consent form, you should have time to consider what is involved, the risks and benefits.
We work closely with clinicians and others to bring to the attention of all those with PBC the clinical studies that are currently recruiting participants. You may or may not decide to take part and we support you in this decision. If you would like to talk through any research project or even ask some questions, you can call us and we can try to help you.