Resources

Protocol Submission and Review Process

An academic health center strives to balance the competing interests of industry, academic researchers, and the public in the development of drugs and devices leading to potential advancements in healthcare. At Penn State Milton S. Hershey Medical Center (PSHMC), we have developed an integrated Research Support Team that is a critical component for streamlining the regulatory, contractual and financial aspects. 

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Q: What is a clinical research trial?
A:
A clinical research trial is a scientific investigation (trial or study) of a research medication or treatment to find out how it works in people. Through clinical trials, doctors help find possible new ways to prevent, detect, diagnose, control and treat illnesses. 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). Participation in clinical trials is completely voluntary and all information provided by a participant is kept strictly confidential and used only for the purposes of conducting the study as required by law.

Q: What happens during a clinical trial?
A:
Participation in a clinical trial means you will work with a research team in a clinical office setting. Team members include doctors, nurses, study coordinators, and other health care professionals. As a qualified volunteer for a study you will receive all medical visits and procedures directly related to your participation in the study at no cost. This can include: physical exams, doctor visits, study medications, laboratory tests, EKG's, etc.

Q: What are the benefits of participating in a clinical trial?
A:
Most of our current information on medicines and diseases has been obtained from research. New drugs are being developed daily and may offer advantages over existing ones. Still, being involved in a research study sometimes makes us uneasy. It helps if we remember the many research successes over the past few decades. For example, vaccines and antibiotics have been developed to eradicate many previously common and deadly diseases such as smallpox, polio, diphtheria, tetanus, and childhood leukemia. It should be remember that there are no guaranteed benefits to your participation in a clinical trial. Any potential benefits to you and society should be discussed with you by your doctor prior to your entry into a study.

Q: How am I protected during the research clinical trial?
A:
Patient safety is the number one priority of the FDA, the pharmaceutical companies, the Penn State Clinical Trials Office and the Penn State Human Subjects Protection Office. Before participating in a study, you must agree to and sign an Informed Consent, which gives detailed information about the study, procedures, and medications including the risks. Experienced physicians who have been thoroughly trained and designated as Principal Investigators monitor you throughout the study. As with any medication, there may be unknown risks from participating in the study. An Institutional Review Board (IRB) must review and approve all studies before you are asked to participate in the study. The IRB is made up of scientific and non-scientific members, clergy, administrators, and members of the public. IRB approval of all research is required by U.S. Food and Drug Administration (FDA) to ensure protection of the rights and welfare of patients who are enrolled in clinical trials.

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

Q: Who participates in clinical research and how are they selected?
A:
Lots of different people like you and I participate in clinical research. Every study identifies some specific characteristics that the participants should have in order to participate. These characteristics are called eligibility criteria. Some of these characteristics are things like age, general health, a diagnosis of a particular disease, certain symptoms, etc.

Q: Why can't I know which drug I am on?
A:
A key element in any research trials is to have accurate results. The study may either compare a research drug to standard therapy or a placebo (an inactive substance). The study coordinator, physician and you may have no idea whether you are receiving the actual drug or a placebo. This ensures that the study trial has been unbiased in the results and will show how the new medication does or does not work.

Q: How do I know my personal information will be kept confidential?
A:
Federal laws mandate that your personal information be kept strictly confidential and that you be informed of all parties who will view that information. These parties typically include your doctor, nurse and/or study coordinator, a representative of the sponsoring organization, and occasionally a representative of the FDA. In most cases this viewed information will have personal identifiers replaced by your initials and study number. The specifics should be discussed with you in detail prior to your entry into a study.