Information for Potential Participants

Why is participation in clinical trials important?

The decision to join a clinical trial is very personal. Nobody should force anyone to join a study. Information about the trials must be provided very clearly, all questions must be addressed, and time must be given to potential participants to reach their own conclusion of whether joining a study is right for him/her.

To join a clinical trial is to participate in scientific discovery. Medical breakthroughs would not be possible without the altruistic participation of volunteers. The decision to join a clinical trial may involve different reasons non-self-exclusionary:

• Sometimes the available treatments do not work and there are no other options
• The participant is uninsured, and he/she will get medication that may work for his/her condition
• Participants want to contribute to drug development and feel good about themselves

It is good to keep in mind that joining a clinical trial brings potential risks and benefits. For example, the safety of the drug is being evaluated and unexpected reactions may occur. Usually, before a drug is evaluated in a clinical trial, several prior studies were conducted in laboratory and in animal models. The results of these studies are reviewed by experts and only after the analysis and conclusion that potential benefits outweigh the risks is that the FDA approves a study to be conducted in humans. However, there is no guarantee that the new drug will work. The research team will be monitoring very closely all the reactions, and the participants will benefit from the regular visits to the clinic and the monitoring provided by the safety tests and follow-ups.

What is an Informed Consent document?

Sadly, in the past, unethical events occurred in which people became part of research studies without their knowledge or consent. The Tuskegee syphilis study is one of these infamous studies in which patients were left untreated to observe the natural history of syphilis. Examples like that provided a general bad reputation for clinical research. A lot has changed and nowadays, a set of strict regulations are in place to guarantee that participants are protected and well informed throughout the study.

The Informed Consent document is the most important document in a clinical research study. This document contains information about the purpose of the study, the procedures involved, the duration of the study, the potential foreseeable risks, the description of alternative treatment options, a statement that participation is voluntary and that refusal to participate will not result in any type of penalty or loss of benefits. This document serves as the basis for a deep discussion about the trial and only after understanding the study can a decision be properly reached. The Informed Consent is a process that can be revised and discussed at any time during the study's conduct.

What happens if I decide to participate in a clinical trial?

1. You will need to give permission, showing that you agree to participate in the study by signing an Informed Consent document
2. A member of the study will explain what happens next

Keep in mind that you have the right to withdraw from the study at any time. It's important, however, to talk to the study doctor first to ensure you exit the study in a safe way.

Currently Enrolling Clinical Trials:

Clinical trials for the following dermatologic disorders/concerns are currently enrolling, or will be opening for enrollment in the near future:

• Atopic Dermatitis
• Cutaneous T-cell Lymphoma
• Cutaneous Lupus Erythematosus
• Hidradenitis suppurativa
• Prurigo Nodularis
• Pruritus
• Psoriasis

For more information on specific studies, please visit our research site.

Compensation: Payment for time and effort in coming for the study visits is usually made at the end of each visit.  The payment is loaded into a Greenphire Clincard, which can be used like a credit or debit card.  Parking is covered by the studies. Depending on the study,  alternative transportation can be arranged, or reimbursement of travel expenses will be offered.

Contact information: Please contact DermClinicalTrials@UCHealth.com or 513-475-7631 with further questions or inquiries.