Patients & Families

Clinical research is the process we use to identify new ways to diagnose, treat, cure and prevent disease. Clinical research is fundamental to how we advance our care for patients today.

Examples include studies designed to:

• Determine if a new drug or device is safe and effective.
• Compare existing treatments to determine if one is more effective than another.
• Study large numbers of patients with the same disease to understand as much as is possible about that disease and identify the best way to take care of patients with the disease.
• Learn how to best use an existing treatment in a new patient population.

People participate in clinical research for many reasons. They want to help physicians and scientists learn more about disease and health. They may want to have the opportunity to receive an investigational medicine or they may want to contribute to overall knowledge about a condition or disease.  

Each research study is designed to evaluate a very specific patient population. This is described in a research protocol as “eligibility criteria” or a set of factors outlining who can participate in a research study. Factors include age, sex, type and stage of disease, previous treatment history, and other medical conditions.
 

Informed consent is the process whereby by research teams ensure that you learn what the study involves, and based on knowing this information you are able to make an informed decision about whether or not you want to participate.

An informed consent form (ICF) contains written details about the study, including its purpose, duration, planned procedures, key contacts, risks and potential benefits. The document can serve as a reference point during the study to which participants can refer back to refresh their understanding of what is involved.

Most costs in clinical research are covered by the research sponsor. The Informed Consent Form (ICF) should explain the possible costs, payments you may receive, and expenses that will be covered. Such expenses may be; travel costs like taxi, gas mileage, or hotel, and time that you may require to take away from work (therefore any related compensation).

There could also be costs for the care you receive in clinical research. Some of those costs can be covered by health insurance. You do not need to have health insurance to participate in clinical research. If you do not have insurance, speak to the trial staff about your payment options. Some funding sponsors have programs in place to pay for care that would normally be covered by insurance.

Oversight of clinical research is often referred to as sponsorship. Clinical research can be sponsored by physicians, medical institutions, foundations, voluntary groups, pharmaceutical companies, and/or federal agencies (such as National Institutes of Health (NIH), the Department of Defense (DOD), and/or the Department of Veterans Affairs (VA).

Clinical research can take place at outpatient clinics ( such as your PCPs office), hospitals, community centers, remotely, and at patients homes.

Who pays for the study depends largely upon the clinical research study. It might be funded by a government agency, pharmaceutical sponsor or by the university / hospital itself.

The process depends on the type of clinical research being conducted. For most clinical research; you will have a screening visit where the research team will determine if you are eligible for the study and,if you are, you will review and sign consent. The informed consent form (ICF) will outline all of the activities that will take place during the study including number of visits, what to expect at each visit, how long visits may be, expected time frame of the study and any potential risks.  

Research, by its nature, is designed to learn what we don’t currently know. Therefore, it is important to note that all research will carry some risk and some studies will have higher levels of risk than others. There is a requirement that every effort possible is made to reduce the risk. The level of risk of all studies is independently reviewed by an ethics committee called the Institutional Review Board (IRB) that is comprised of physicians, statisticians, and community advocates. They are charged with ensuring that a research study is ethical and that the rights and safety of study participants are protected. If you are considering participating, it is important that you carefully read the informed consent form and ask the study team to explain all known risks in detail.

The level of risk is different in each clinical research study. Some observational studies have very minimal risk while other studies with unapproved new products might have a higher risk. Efforts are made to control the risks to clinical research  participants, however some risks may be unavoidable when studying new medical treatments. The informed consent outlines the potential risks to the research participant. Researchers are required to give eligible participants complete and accurate information about what will happen during the clinical research study so they are fully informed before giving consent to participate.

There are generally known and unknown risks associated with clinical research, 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.

When your research participation is coming to end, you will usually have a final research visit with the research team. At this time, research teams may collect any remaining medication, complete any final procedures and for you to ask remaining questions or follow up items. This might also be a time for the team to share with you any results with you, that they had to withhold during the study. 

If you think you have received a bill by mistake, please send a copy of your bill to psom-ocrfin@pobox.upenn.edu along with the name of the study you are in, the name of the investigator/physician leading the study and the IRB number (6 digit number on your consent) if you have it.

OCR Finance can assist with any billing discrepancies including any professional or hospital charge(s) erroneously billed to the patient’s personal family account (i.e., insurance company).