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Why Participate in a Clinical Study

These viewpoints and experiences are from someone who participated in a prior SetPoint Medical study. Individual decision-making and experiences may vary.

What should one consider when deciding whether to participate in a clinical study?

Therapies approved today for Rheumatoid Arthritis (RA) have had to go through regulatory procedures, including clinical studies, before the FDA (US Food and Drug Administration) allows its commercial use. Those who participate in clinical studies have early access to an investigational therapeutic approach, as well as a dedicated study team focused on providing study participants with on-going, closely monitored healthcare.

Assessing New Options and Overcoming Barriers

People living with RA know the necessity of new treatment options as they are constantly balancing their symptom relief with the side effects and costs of the RA drugs. There is a significant need to ensure we are studying new treatment approaches that might improve upon today’s standard of care.

By participating in clinical research, you become a pioneer in the early days of a therapy that may have the potential to advance the future of treatment for the RA, and perhaps provide learnings for the broader patient community.

Unfortunately, clinical study enrollment across disease indications, including Rheumatoid Arthritis, is at an all-time low. While there are many factors to consider when deciding whether to participate in a clinical study, often, it’s fear of the unknown that may cause reluctance towards participating in a clinical study. This is completely natural – even when a treatment isn’t working, many may feel more comfortable and safer in the predictability of their current care routines rather than trying a new approach that is unknown and investigational.

“However, you can better evaluate your options by reviewing the science and understanding the details of the investigational approach being assessed in the clinical study.”

The reality for many people who suffer from RA, despite trying multiple medications, is that there are two options: one, to remain as is, with status quo of constant chronic pain, reliant on drugs that are expensive and often come with undesirable side effects, or the second option: to take a chance and try an entirely new, albeit investigational, treatment approach.

While the second option is investigational and there are no guarantees of benefits, a clinical study is your opportunity to be a pioneer in developing revolutionary treatment approaches.

Therefore, it is important to immerse yourself in learning as much as you can about the science and the mechanism of action of the new approach being studied in RESET-RA, and understand the potentials risks and benefits of participating in the clinical study.

How to enroll in a clinical study?

Those who participate in clinical research have an opportunity to experience patient care through a different lens while seeing firsthand the field of science and medicine converge. As a participant in research, it’s important to be fully informed on what your participation involves, what your role in the study entails, and then decide what’s best for you.

When applying to participate in a clinical study, you will hear a lot of terms that may be new to you, and these include:
 
Eligibility criteria: U.S. clinical studies for a new investigational therapy have a protocol that is approved by the FDA and IRB, and followed by the study’s research doctors, to evaluate an investigational therapy in a specific group of patients.
 
Clinical study protocol: This refers to the set of procedures to be followed by the investigators, study coordinators, and study participants. It includes a schedule of appointments and procedures, as well as guidelines for all involved to abide by to ensure that the study procedures are standardized, the safety of patients is protected, and that the effectiveness of the therapy being investigated is accurately evaluated.
 
Informed consent: This is a document that the study team will carefully go over with participants to ensure they understand exactly what they are signing up for if they choose to be in the study. This includes what will be expected of them (how many visits and when), any potential benefits and risks related to study participation, and so forth. It is important that you take your time to review this document and ask the study team any questions you may have before signing the informed consent form. The informed consent form is not a contract. Even after signing the informed consent, you can withdraw from the study at any time.
 
Rescue therapy: If your disease activity does not improve or worsens during the study, ‘rescue therapy’ may be given to help treat the symptoms or flare-up. The medications utilized as rescue therapy typically include therapies that are currently the standard of care and FDA approved, for example biologics or DMARDs that you may have already tried. Rescue therapy, therefore, gives your study doctor the option to intervene with all currently available treatments to help treat your RA, if needed. The RESET-RA study allows for rescue therapy for RA.
 
Control group (also called ‘placebo control’ or ‘sham arm’): Do not despair upon hearing this term! Before we discuss what this means, it’s important to highlight that in many studies, including the RESET-RA study, all patients receive the study treatment after reaching the three-month mark and can continue with the therapy for the rest of the study. With that preface out of the way, let’s talk about what a control group is and why it is important. If the clinical study is randomized, it includes what’s called a ‘control group’ and a ‘treatment group.’ The ‘treatment group’ gets the new investigational treatment being studied, and the ‘control group’ gets currently approved and available treatments pre-specified by the protocol. The reason it is important to include a ‘control group’ at the beginning is to ensure that the therapy being tested actually does something when measured against a group that is getting only the standard of care treatment, which, in the case of RESET-RA, is DMARDs. During the Informed Consent process mentioned above, the clinical study coordinator will discuss this with study participants.
 
Along with knowing these terms, it’s also important to know that your study costs are covered, and you can withdraw at any time, with no penalty. What’s more, participating in clinical studies doesn’t limit your typical care – in fact, while most people with a chronic illness check in with their specialists every three to six months, or perhaps only during periods of flare-ups, when participating in a clinical study, you have access to a dedicated clinical study coordinator with whom you can check in at any time. The clinical study coordinator is one of the best resources for you throughout the study – they will be someone you will rely on to get you in for appointments as needed, schedule your follow-ups, and answer any question you have about the study. 

Let’s say you’re ready to explore this new investigational option and find out if you can participate in the RESET-RA clinical study – where do you start? 

  1. Review the eligibility criteria and take the qualification questionnaire to see if you qualify.  
  2. If you do, you will be able to set-up a phone appointment with a health care professional who will review the eligibility criteria and answer questions about the study. They will also help you find a study center nearest to you and connect you to that center.
  3. You will then need to visit the study center in person and review the informed consent form with the site’s study coordinator – and if you so choose, sign the consent to start the process!
We appreciate you considering participation in the RESET-RA study.

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