Taking part in a clinical trial is a personal decision that needs to be well-thought out and reflected according to your best interests as a participant. Remember that at any time you are free to refuse or withdraw from a clinical trial.
Understanding the study purpose
Clinical trials have different purposes and requirements. Therefore, take the time to read and thoroughly understand the goal of the study. Here are some examples of study questions commonly researched in psoriasis and arthritis psoriasis:
- Is it to test the efficacy or side effects of a new treatment cure?
- Is it to minimize symptoms and improve quality of life?
- Is it to understand the association of psoriasis with certain activities or triggers?
- Is it to understand the long-term effects of a new medication?
Potential benefits and risks of participating
It is important to weigh all potential benefits and risks. As clinical trials research unanswered questions and evaluate novel treatments, uncertainty related to treatment efficacy and safety remains an important factor to consider.
Please note that these are not all potential benefits of all studies. Potential benefits vary based on the study. The following benefits may or may not be applicable to all studies.
- Treatment efficacy:Your disease severity may improve or even be cured.
- Quality of life: Your symptoms may improve.
- Access to new treatments and healthcare:Being among the first participants in the world to test a novel drug treatment that could improve your quality of life and the lives of other patients.
- Role in advancing science:You are contributing to advancing knowledge in psoriasis or arthritis psoriasis.
- Health follow-up:You are monitored by a healthcare team while you are in a clinical trial.
- Cost of medical care: You will have access to medical care and therapeutic treatments at a free or low cost. You could also benefit from it after the study for a certain period.
In case of adverse effects or health issues, participants receive all the medical care needed. Adverse effects are also reported in study results and reported to regulatory entities.
- Disease severity:Your disease severity may worsen or impact your quality of life.
- Side effects: Possible unknown treatment side effects.
- Constraints: You will potentially have to modify your everyday schedule to fit the study requirements (e.g., frequent visits to plan, testing and procedures, daily restrictions on certain activities)
- Treatment uncertainty: You don’t know the medical intervention that you will receive (e.g., control or experimental group).
- Confidentiality: Despite rigorous measures taken in all clinical trials to protect your privacy, you may fear or feel uncomfortable with potential security breaches.
- Discomfort: You may experience physical or emotional discomfort related to some procedures in the clinical trial (e.g., a skin biopsy).
To enroll in a clinical trial, all participants need to meet all the eligibility requirements. A member of the research team will walk you through the requirements. Don’t hesitate to discuss with your healthcare provider (e.g., general practitioner or specialist) regarding your health status and other treatment options before enrolling.
Informed consent is a process where the research coordinator and/or a member of the research team will walk you through the study informed consent form, which explains how the clinical trial works, the expectations of participants, etc. Before enrolling in a clinical trial, it is important to understand and evaluate the potential risks and benefits as a participant. Take your time to ask questions and understand your role throughout and after the clinical trial. Familiarize yourself with new medical terms or concepts.
Your decision is free-willed. Remember that you should not feel pressured or obligated to participate. If you decide to participate, you will sign a consent form, which means that you agree to participate and that you acknowledge the potential risks and benefits associated with the study. As part of the informed consent, you can decide to withdraw at any time. Even if you decide to be part of the study, you can change your mind at any time.
Once you are enrolled, you will be assigned to a contact person in case of any questions or medical concerns throughout and/or after the trial. This contact person is your first resource person. It is important to inform and report to this person of any health concerns or health changes that you notice during or even after the trial.
Don’t forget to inform your healthcare provider of your interest or of your participation in a clinical trial. Your general practitioner or specialist can advise you and better follow you after study completion.
Patient organizations represent a helpful resource before, during and after participating in a clinical trial. They can put you in contact with people who previously participated in one and/or provide support through patient support groups. They can also inform you of ongoing and/or actively recruiting clinical trials.