What is a clinical trial?
A clinical trial is an organized program designed to determine the safety and effectiveness of a new therapy (drug or device). The University of Pennsylvania's Office of Human Research has a list of frequently asked questions for patients who are considering participating in research.
What is protocol?
A protocol is a clearly defined written plan that describes the "what, how, when, and why" of how the clinical trial will be organized and implemented. Penn's Office of Human Research has a list of frequently used research terms for patients to review who are considering participating in research.
What is the difference between the care I receive if I participate in a clinical trial versus the care I receive if I do not enroll in a clinical trial for my condition?
Should you want to participate in a trial, your doctors will meet with you to discuss the benefits and risks associated with the trial as it pertains to your specific condition.
In general, participation in a clinical trial provides you with closer monitoring and more frequent follow up visits with your doctor and study team. In addition, participating in a clinical trial may offer you access to experimental technologies, therapies, and/or medications new to the field.
Your doctors at Penn Medicine are committed to providing you with the highest level of care, regardless if you do or do not participate in a clinical trial.
Will I be paid if I participate in a clinical trial?
Each trial has its own specific financial compensation. Some trials do not provide payment for participation in research, while others do. If payment for participation is an option, the research doctor or study coordinator will advise you of this when you come in to talk to them about the study.
Will I have to pay for anything?
Each trial will have its own specific guidelines for financial reimbursement. Please read the study consent form very carefully to determine what that reimbursement may or may not be.
You and/or your health insurance may be billed for the costs of medical care during this study, if these expenses would have happened even if you were not in the study, or if your insurance agrees in advance to pay.
How is research conducted at Penn?
Federal regulations govern the conduct of clinical trials. Institutional Review Boards (IRBs) are independent committees empowered by the government to review, approve, or deny clinical trials. At Penn, IRBs are part of the Office of Regulatory Affairs.
Additionally, Penn has its own institutional departments and committees that also oversee clinical trials that involve human subjects. These include the Office of Human Research (OHR), which has a section on its website dedicated to Research Patients/Volunteer Information. Please refer to the OHR website for more information.
What if I want to withdraw from the study after I have signed consent to participate?
You can withdraw from the study at any time. Participation is voluntary and completely up to you. Your doctor may also withdraw you from the study should he/she believe it is necessary for your health or safety. The Food and Drug Administration (FDA) may also decide to stop the study. Withdrawal will not interfere with your future care.
Will my health information be kept confidential?
All personal health information will be kept in the strictest confidence. Typically, in all disclosures outside of Penn Medicine, you will not be identified by name, social security number, address, telephone number, or any other direct personal identifier unless disclosure of the direct identifier is required by law.
Every patient receives Penn's HIPAA: Notice of Privacy Practices document that explains how medical information about you may be used and disclosed.
If you are already enrolled in a neurosurgery clinical trial, please refer to the Research Subject Authorization Confidentiality & Privacy Rights for specific details about how your personal health information will be used.
If you are already enrolled in a neurosurgery trial and have specific questions related to your study, please call any of the doctors or nurses listed on the front page of your consent form.
If you have general questions related to neurosurgery clinical trials you may call Eileen Maloney-Wilensky, neurosurgery clinical research division director, at 215-662-6462.