Participate in Research

Clinical research is a scientific investigation to find out how a potential medication or treatment works in people.

Through clinical research, researchers find new ways to prevent, detect, diagnose, control and treat illnesses. Most of our current information on medicines and diseases has been obtained from research. New drugs are being developed and may offer advantages over existing ones. For example, vaccines and antibiotics have been developed to end many previously common and deadly diseases such as smallpox, polio, diphtheria, tetanus, and childhood leukemia. Participating in clinical research studies allows you to be a part of this process.

Clinical research studies are available for people with specific diseases and for healthy people who want to help advance science. Every study identifies the specific characteristics that the participants must have in order to participate. These characteristics are called eligibility criteria. Some of these criteria include age, general health, a diagnosis of a particular disease, certain symptoms, etc.

Many clinical research studies rely on healthy volunteers – those without a particular condition. Often, healthy volunteers are used as a comparison to a similar person with a condition. This helps scientists understand differences and similarities in people and how diseases affect them differently.

There are no guaranteed personal benefits from participation in a clinical research study. Any potential benefits will be discussed with you as part of the consent process. Your involvement may help future patients and advance science and understanding of disease. Some studies may offer compensation for your time.

Participation in clinical trials or studies is completely voluntary. You must agree to participate and you’ll be asked to sign a consent form, which gives detailed information about the study, procedures, medications and risks.

Participation in a clinical study means you will work with a research team in a medical setting. Team members include doctors, nurses, study coordinators, and other health care professionals. A principal investigator monitors participants during the research study. How the study will be conducted will be explained to you during the consent process.

While clinical research trial personnel do not diagnose health issues, nor are they an extension of your primary care team, if there is a concern that arises, you will be advised to schedule an appointment with your own health care provider to be properly examined.

White it is different for every study, most studies cover the cost of examination and procedures for the study. This can include physical exams, doctor visits, study medications, laboratory tests, EKGs and more.

Participating in a clinical trial or study is completely voluntary and you can leave the study at any time if you change your mind.

Clinical trials for new medications will often list a "phase" in their description. Here is what those phases indicate:

• Phase 1: This is an study in a small group of 20 to 80 people in which researchers evaluate the drug's safety, determine how it works in the human body. It also identifies side effects and is used to determine a safe dosage.

• Phase 2: This study looks at how effective the drug is in a slightly larger group of people, generally between 100 to 300. Further safety evaluations are also done at this phase.

• Phase 3: A phase 3 study is done after early evidence suggests the drug is effective. This is an expanded trial that includes thousands of people, both those taking the medication and people not taking it. It is used to confirm effectiveness, monitor side effects, and compare the new drug to commonly used treatments for the same condition. 

• Phase 4: These studies are done after the drug has been marketed. They are done to collect information about the drug's effect in specific populations, and to measure any side effects associated with long-term use.

Being involved in a research study can be a big decision. The U.S. Food and Drug Administration (FDA) has numerous regulations in place to make research as safe as possible. In addition, Penn State College of Medicine has a Clinical Trials Office and a Human Research Protection Program to monitor studies and keep safety a top priority. You are encouraged to discuss all potential issues with the study personnel and your healthcare provider to make an informed decision before agreeing to participate.

What about medication trials?

Before a new medication can be approved for use by the public, it must be tested thoroughly according to strict guidelines established by the U.S. Food and Drug Administration (FDA). Before it can be tested in humans, the drug has gone through pre-clinical studies to try to predict the drug safety and effect on humans. As with any medication or treatment plan your doctor might prescribe, there can be unknown risks, but careful monitoring is in place to reduce this risk during a clinical study.

Are clinical research studies approved somehow? How do I know they’re legitimate?

An Institutional Review Board (IRB) reviews and approves all studies. The IRB is made up of scientific and non-scientific members, administrators, and members of the public. IRB approval of all research is required by the U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials. For questions, please contact the Human Research Protections Program (HRPP) by phone at 814-865-1775 or by email at irb-orp@psu.edu.

Do I definitely receive the experimental drug if I'm in the study?

A key element in any research trials is to have accurate results. To determine what effects a drug has on humans, some studies may use a placebo – a pill or medication with no active drug in it – to compare to the active drug. The study coordinator, physician and you may not know whether you are receiving the actual drug or a placebo while you take it. This ensures that the study trial is unbiased in the results, and will show how the new medication does or does not work. In many cases, you may receive the study drug for a length of time, and a placebo for a certain length of time; or you may remain on your normal treatment while testing the new medication.

How do I know my personal information will be kept confidential?

Federal laws mandate that your personal information be kept confidential and that you be informed of all parties who will view that information. Typically, that could include the principal investigator, a study nurse and/or study coordinator, a representative of the study sponsor (such as a drug company), and occasionally a representative of the FDA. In most cases, this viewed information will have identifying information replaced by initials and study number. The specifics should be discussed with you in detail prior to your entry into a study. Your information will not be shared outside of the purposes of conducting the study unless you provide consent to do so. For example, some people provide consent to use their data from a study in additional future research.