Rheumatoid Arthritis Research

How is participant wellbeing protected during a clinical trial?

One of the responsibilities of the healthcare team who run clinical trials is to care for participants. The healthcare team is typically made up of doctors, nurses, and trained researchers. This means that they are trained to look after your safety and health.

Clinical trials also have a regulatory and ethical framework to protect participants. Everyone conducting a clinical trial has strict regulatory and ethical duties. Teams of people, called an Ethics Review Board (ERB) or Institutional Review Board (IRB), operate independently from the day-to-day conduct of research. An ERB or IRB reviews every clinical trial before people can take part. This is to ensure that the correct steps are taken to protect participants' welfare and rights. An ERB or IRB protect participants by:

• making sure that clinical trial risks are as low as possible for participants;
• ensuring the potential benefits of the clinical trial outweigh the risks; and
• making sure that a clinical trial meets overall safety requirements for participants.

After joining a trial, can a participant stop taking part?

A participant may stop taking part in a clinical trial at any time, for any reason. No matter the stage of the trial, a participant has the right to change their mind and withdraw. If a participant decides to withdraw, the study doctor will remove them from the trial in a way that is safe for the participant.

As a clinical trial participant, you would contribute to the long history of volunteers around the world. Together, trial participants help researchers answer important health questions and discover new medical treatments.

Once a clinical trial is complete, the results will be available online. You can search for completed Lilly clinical trials on our completed trials page.

Before joining a clinical trial or completing any trial-related activities, potential participants are given information about the study and have the chance to ask questions. This process is called informed consent.

The informed consent process will help you understand:

• the purpose of the clinical trial;
• what will happen during the clinical trial; and
• the risks and benefits of taking part.

Informed consent begins before a person agrees to participate in a trial or completes any trial-related activities and continues throughout the study.

For rheumatoid arthritis clinical trials, participants may need to visit the study doctor more often than they would for normal care. During the clinical trial, there are different types of assessments. These may include:

Physical exams

• In these exams the study doctor may focus on areas that can be affected by rheumatoid arthritis such as the joints, skin, and eyes.
• They will also usually listen to your heart and lungs and check if your abdomen (belly) is tender by gently pressing on the area.

Lab tests and other assessments

Blood samples

• To check for infections, your blood count, cholesterol levels, how organs like your liver and kidneys are working, and if you are pregnant. They may also look for rheumatoid arthritis markers in the blood.

Other measurements

• Weight, height, and vital signs such as your temperature, heart rate and blood pressure are also recorded.

Patient Reported Outcomes (PRO) Questionnaires

Rheumatoid arthritis can have far-reaching impacts on a person's social and emotional well-being and quality of life. An important part of clinical research studies is to assess the impact the condition is having on these different areas. This is usually done by completing questionnaires designed for this purpose.

After the trial, a participant should work together with their primary doctor to figure out the best next steps and care plan.
The investigational medicine (the medicine that was studied) may need to be looked at in more clinical trials. It may also be reviewed by regulatory agencies and approved for use outside of a clinical trial.