I’m writing this blog because the Lupus Research Alliance, and its affiliate, Lupus Therapeutics is determined to drive discovery and development of new treatments for lupus! I am proud to serve as Executive Director of Lupus Therapeutics, which serves as fiscal and administrative agent of the Lupus Clinical Investigators Network (LuCIN), a network of 57 academic research medical centers focused on partnering with clinical investigators and industry within the lupus community to evaluate therapies that are potentially safer and more effective in treating lupus .

Currently, we have seven (7) studies underway within LuCIN, testing potential ways to better monitor and treat lupus.

The Need for New Treatments
Treatments aren’t perfect for lupus, but they generally work.  They’ve gotten better.  Unfortunately, as is often the case with chronic illnesses, the treatments that are used for long-term care can often increase chances of long-term toxicity.

Lupus manifests itself differently in different people.  A lot of the research that we’ve conducted has really helped to understand the basic biology behind lupus.  Translational science that has helped to segment and target more specific drugs based on genetic makeup.  There’s a long way to go, but on a molecular medicine level, there has been a lot learned about how to potentially target certain therapies to personalize approaches.  We’re headed in the right direction, and lupus is a prime candidate because it affects a very heterogenous population.

You Can Help
The FDA is the ultimate arbiter as to whether a drug will be approved.  But bridging the gap between patients and the FDA is important so they hear directly from the people who are affected.  For instance, fatigue is very frustrating for many who live with lupus, but it’s not used as a clinical endpoint in trial design.  The FDA is becoming more receptive to hearing about daily life experience.  We’ve conducted meetings, and the FDA is listening and considering how to design trials with input from patients early on so that these kinds of endpoints are addressed and met.

Take information to your doctor.  Ask them how to get involved.  Research on our website.  Find the information that you need to decide about joining a clinical trial.  Ask your doctor if you’re a viable candidate based on the individual and the study requirements.

LuCIN centers are in nearly every large market in the United States and Canada.  There’s a high probability that there’s a trial you can get involved with in those areas.  (Visit our website dedicated to lupus clinical studies — lupustrials.org.)

It’s important to remember that you’re not alone.  There’s an opportunity to be an active participant in studies that can improve your symptoms and those of people who are diagnosed with lupus in the future.  There are a number of opportunities that will only improve our chances of figuring out this disease and how to treat it.

Get active!  Without individuals participating we’re not going to move the needle.  We’re not going to improve treatments.  There won’t be new treatments.  The only way to more forward is for people to get actively involved.  There’s a direct correlation between participation in trials and the outcome of that disease and it’s likelihood of success.  We’re here to help educate, we’re here to talk with you about your concerns about clinical trials.

For more information on LuCIN and lupus trials, read these FAQs.

Knowing what to expect with a clinical study:
A stringent screening process goes through the eligibility protocol of the trials for anyone who wishes to participate.  Applicants must satisfy a number of areas of Some of the factors considered are:

Severity of disease.  Does it fall within the range of eligibility for the study?

Any other things that might prohibit participation, such as organ involvement.

Answer questions related to study.

Questions patients might consider before signing up:
How long will I be in the study?

Will I be allowed to keep taking my other medicines?

How do I take this medicine?

Will this make me feel better?  Worse?

How often will I need to visit the clinic for treatment or labs?

Informed consent:
Informed consent must occur before you’re officially enrolled in a clinical trial.

Potential participants will talk in detail about requirements for participation in the trial and what the person is signing up for, including risks and possible benefits.

After all qualifications are vetted and met, participants will give their consent and be enrolled in a clinical study.