What are clinical research studies?
Clinical research studies are designed to test the safety and effectiveness of investigational study drugs. Regulatory agencies worldwide require that, before any drug can be prescribed to a member of the public, it must go through multiple phases of research.
All clinical research studies follow strict guidelines to help ensure that the rights and health of participants are observed during the study while allowing researchers to collect valuable information about the investigational study drug.
Why are clinical research studies conducted?
Clinical research studies are needed to determine whether an investigational study drug is safe and effective. Every new investigational drug must have completed the appropriate clinical research to see if it can be approved by government agencies for use in the public.
What is informed consent?
Informed consent is the process that allows you to learn the most important facts of a clinical research study. Before participating, we will take you through a written Informed Consent Form (ICF) that outlines the important information to read and consider before joining the study. The study doctor will go through this document with you and answer any questions you may have.
What should you consider before participating in a clinical research study?
Participation in a clinical research study is an important decision and should be carefully thought through. You should never feel that you have to participate in a clinical research study. Even if you join the study, you can cancel your participation at any time for any reason. You will have the right to receive the same standard of care as you did before joining, however, you will not be able to continue taking the investigational study drug. A study doctor will discuss other options that may be available to you.
Why should I join a clinical research study?
Many people take part in clinical trials for different reasons.
- Access to new investigational drugs: by participating in a clinical research study you may gain access to new investigational drugs that would otherwise be unavailable and contribute to medical research which may help other people in the future.
- Study-related medical care: you will receive study-related care from a clinical research study team composed of doctors, nurses, and other medical professionals who are committed to your well-being and to research that may lead to better future options for the treatment of psoriatic arthritis.
- Flexible participation: remember there is no guarantee that you will benefit by participating in this clinical research study, and if you choose to participate, you are free to withdraw at any time for any reason. You will have the right to receive the same standard-of-care treatment as you did before joining. A study doctor will discuss other options that may be available to you.