Office of Clinical Research

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There are several ways to become involved in research as a volunteer.

• Talk with your doctor
  Depending on your health status and any medical conditions you may have, your doctor may inform you of research study opportunities

• Review instructions for how to Find a Study below

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1. Search for Research Studies
   Search by a key word, medical condition, or the name of a particular doctor
2. Review your Matching Studies
   You will be shown a list of research studies that matches your search
3. Contact the Study Investigator
   You will receive contact information for the research investigator. You should contact the research team if you are interested in learning more or in volunteering to participate.

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Learn more about clinical research studies and what it means to be a clinical research participant:

What is a clinical trial?
A clinical trial is a research study involving human volunteers and is designed to answer specific health questions.

Clinical Trials are studies that take an in-depth look at new ways to diagnose and treat a health condition. Participants may benefit from:

• Access to innovative therapies and treatment options.
• Expert medical care for their condition.
• Active involvement in their health care and treatment plan.
• Contributing to medical research.

Why are clinical trials performed?
Clinical trials may be performed to:

• Determine if a new drug or device is safe and effective.
• Compare existing treatments to determine which is more effective.
• Study different ways to use existing treatment so they will be more effective, easier to use, or have less side effects.
• Learn how to best use an existing treatment in a new population, such as children.

Why do people participate in clinical trials?
People enroll in clinical trials for many reasons. In general, participants help advance what is currently known about existing or new medications and devices, and can play an important role in making those treatments available to new populations.
 
Who is eligible to participate in a clinical trial?
It is important to remember that the main purpose of a clinical trial is study a new or existing medication or device- not to treat patients.
For each clinical trial, researchers develop “eligibility criteria”; this is a set of factors outlining who can participate in a trial. Factors include age, sex, type and stage of disease, previous treatment history, and other medical conditions.
Eligibility criteria help to reduce the amount of variation in the study to ensure the results are as accurate as possible.
 
What happens during a clinical trial?
The process depends on the type of clinical trial being conducted. The clinical trial team includes doctors, research coordinators and other health care professionals. For trials conducted by the University of Pennsylvania this team administers clinical trials according to the strict rules set by the Federal Office of Human Subject Protections and/ or the Food and Drug Administration (FDA).
 
Who sponsors clinical trials and where are they conducted?
Clinical trials can be sponsored or funded by, physicians, medical institutions, foundations, voluntary groups or pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran’s Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors’ offices or community clinics.
 
Are clinical trials safe?
The Federal government sets rules for clinical trials to ensure that participants are treated as safely as possible. In addition, studies conducted at the University of Pennsylvania must be reviewed and approved by the Penn Institutional Review Board (IRB). An IRB is an independent committee of physicians, statisticians, community advocates and others who ensure that a clinical trial is ethical and the rights of study participants are protected. Research investigators must regularly update the IRB on the study’s progress. In addition, Penn Medicine’s Office of Clinical Research provides training for the clinical trial team and conducts audits of certain drug and device trials.
 
What is informed consent?
Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate in a clinical trial, the research team explains the details of the study. Translation assistance is available. Then the clinical trial team provides the participant with an informed consent document with written details that were discussed about the study, such as its purpose, duration, requested procedures, key contacts, risks and potential benefits. The participant then decides whether or not to sign the document. Informed consent is not a contract; the participant can withdraw from the trial at any time.
 
What are the risks of participating in a clinical trial?
Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable when studying new medical treatments. Researchers are required to give eligible participants complete and accurate information about what will happen during the trial so they are fully informed before giving consent to participate.

There are generally known and unknown risks associated with clinical trials, such as:

• There may be unpleasant, serious, or even life-threatening side effects resulting from the study treatment.
• The treatment may not be effective for the participant.
• The protocol may require more of the participant’s time and attention than a standard treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

What happens after the trial?
Once all participants have completed the study and all data collected from the trial is properly entered into the trial database, the study data can be analyzed to determine the answer to the specific health question posed in the research study.

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Office of Clinical Research (OCR)
The OCR can assist you in identifying research participation opportunities. The OCR works closely with faculty who are conducting clinical research at University of Pennsylvania Healthy System to recruit research participants.

General Hours: Monday to Friday 9:00 a.m. – 5:00 p.m.
Phone:  215-662-4484
Email: psom-ocr@pobox.upenn.edu 

Institutional Review Board (IRB)
You may contact the IRB if you would like to learn more about the ethical conduct and oversight of human research studies.

General Hours:  Monday to Friday 9:00 a.m. – 5:00 p.m.
Phone: 215-573-2540
Email: irb@upenn.edu

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