FAQ

1) What is a clinical trial?
2) Why are clinical trials done?
3) Who can participate in a clinical trial?
4) What are the benefits and risks of participating in a clinical trial?
5) Does it cost money to participate in a clinical trial?
6) Are clinical trials safe?
7) What is informed consent?
8) Is my health information protected in a clinical study?
9) What role does Oregon Medical Research Center have in bringing new treatments to people?
10) Who should consider clinical trials and why?
11) What should people think about before joining a clinical trial?
12) What’s the role of the FDA in approving new drugs & medical treatments?


1) What is a clinical trial?

A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and fastest way to find treatments that work in people, and new ways to improve health.

There are different kinds of clinical trials, including those to study:

  • prevention options
  • new treatments or new ways to use existing treatments
  • new screening and diagnostic techniques
  • options for improving the quality of life for people who have serious medical conditions

Clinical trials are conducted according to a plan called a protocol. The protocol describes what types of patients may enter the study, schedules of tests and procedures, drugs, dosages, and length of study, as well as the outcomes that will be measured. Each person participating in the study must agree to the rules set out by the protocol.

A new investigational drug or treatment must be shown to be both safe and effective before it can be considered for approval by the U.S. Food and Drug Administration (FDA). The process for approval can take many years and has many different steps. Each drug must pass through at least four phases to be approved.

Phase I trials are the first step in testing a new drug or other products in humans. These are performed after extensive testing in animals with satisfactory safety results. These are small studies where everybody in the study is given the same treatment. Phase I trials answer questions about the best way to give a treatment and how much of it can be given safely. The study staff watches carefully for harmful side effects and other possible risks.

Phase II trials are larger studies that continue to test the safety and effectiveness of a new drug or product in a larger number of people and generally compare the product with a “placebo” or “blank” treatment. This is done in a “blinded” and ”randomized” manner in which neither the physician nor patient knows which product is being administered.

Phase III trials are larger and longer studies that are done if the new drug showed promise in Phase II studies. Phase III trials are the final steps toward approval of a new drug or product by the FDA. Phase III trials are usually “blinded” and “randomized.” Participants agree to be randomly selected, that is, assigned by chance, to one group or another in the research study.

Phase IV trials involve drugs or products that are already approved by the FDA. These studies are performed for a variety of reasons which may include addressing different doses or regimens, applied to different medical conditions, or comparative studies for generic approvals.

2) Why are clinical trials done?

Many clinical trials are done to see if a new drug or device is safe and effective for people to use. Clinical trials are also done for other reasons. Some compare existing treatments to determine which is better. The current, approved treatments are called the “standard treatments.” Sometimes clinical trials are used to study different ways to use the standard treatments so they will be more effective, easier to use, and/or decrease side effects. Sometimes, studies are done to learn how to best use the treatment in a different population, such as children, in whom the treatment was not previously tested.

For most trials, researchers, doctors, and other health professionals administer the clinical trials according to strict rules set by the Food and Drug Administration (FDA). FDA sets the rules to make sure that people who agree to be in studies are treated as safely as possible.

3) Who can participate in a clinical trial?

Every clinical trial attempts to answer some very specific research questions. To do this, each trial has certain requirements about health, age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Potential participants must meet the requirements of a particular trial to be an eligible volunteer.

4) What should I think about before joining a clinical trial?

People should learn as much as possible about the clinical trials that interest them. They should also feel comfortable discussing their questions and concerns with members of the health care team. Prospective participants should understand what happens during the trial, the type of health care they will receive, and any costs to them – which may or may not include the cost of the product, costs associated with administering the product, etc.

Anyone considering a clinical trial should also know that there are benefits and risks associated with participating.

5) What are the benefits and risks of participating in a clinical trial?

The benefits of participating in a clinical trial include the following:

  • Clinical trial volunteers gain no-cost access to potentially effective treatments before they are available to the general public.
  • Due to the nature of the safety processes, labs and tests, clinical trial participants receive regular and careful medical attention from a research team that includes doctors, nurses, and other health professionals.
  • The investigational treatment being studied may potentially be more effective than what is currently available on the market.
  • By participating, clinical trial volunteers may help other people who need treatment for the same condition in the future.
  • Accordingly, clinical trial volunteers help scientists and physicians learn more about the condition or disease for which the treatment is being tested.

The potential risks of participating in a clinical trial include the following:

  • Because the investigational medication is new and has not been through an approval process like other medications or devices on the market, there will be information that is not known. The medication or device may not be better than what is currently available and/or it may have harmful side effects that are not expected.
  • Being a part of a clinical trial means that participants will have more office visits than what would likely be needed if you were not in a clinical trial.

6) Does it cost money to participate in a clinical trial?

Volunteers do not pay any money to participate in a clinical trial. In fact, most often volunteers are compensated for their time and travel associated with the trial. Each study is different, but the amount provided to each participant is detailed in the informed consent that is provided before a volunteer begins a study.

7) Are clinical trials safe?

The FDA works to protect participants in clinical trials and to ensure that people have reliable information as they decide whether to join a clinical trial. The federal government has regulations and guidelines for clinical research to protect participants from unreasonable risks.

Although efforts are made to control the risks to clinical trial participants, some risks may be unavoidable because of the uncertainty inherent in medical research studies involving new medical treatments.

The government requires researchers to give prospective participants complete and accurate information about what will happen during the trial. Participants must sign an “informed consent” document before joining the study indicating they understand that the trial is research, and that they can leave the clinical trial at any time. This informed consent is part of a process that ensures a prospective participant in a clinical trial understands what known risks might be associated with the study, and whether there are potential, but as yet unknown risks that may be associated with the product being studied. This information permits someone deciding whether or not to enter a clinical trial to make an informed decision about the level of risk they are willing to accept before they enter the trial.

8) What is informed consent?

Informed consent is a process of communication between researchers and volunteers for clinical trials. The goal of the informed consent process is to protect participants. It begins when a potential participant first asks for information about a study and continues throughout the study until the study ends. You can expect to receive very detailed written and verbal information about the study from the physician including:

  • All the important information about the study length, time commitment, visits, compensation, confidentiality, etc. so you have the information to choose to enroll or participate
  • All the potential risks and benefits of participating in the study, including the alternatives to the research being conducted
  • The information that enrolling in and staying in a clinical study is completely voluntary and that participants can leave a study at any time. The informed consent is not a contract, it is a process
  • Most importantly, you will be given time to read the informed consent document and ask any questions you may have.

Although there is an informed consent document that must be signed, the process of communication continues throughout the study. In many cases, information about the investigational treatment or changes to the study protocol will occur during a study and a new informed consent will be discussed and signed.

9) Is my health information protected in a clinical study?

Confidentiality is an important part of clinical research and ensures that personal information is seen only by those authorized to have access. It also means that the personal identity and all medical information of clinical trial participants is known only to the individual patient and researchers – it is never passed along to the drug companies sponsoring the studies. Results from a study will usually be presented only in terms of trends or overall findings and will not mention specific participants.

10) What role does Oregon Medical Research Center have in bringing new treatments to people?

To answer that question, it is helpful to understand the overall drug approval process. Generally, it takes many years and many steps for a new medication to be available to a doctor to prescribe it to a patient. This is a somewhat simplified version of that process:

A scientist discovers a molecule or develops a compound that he or she thinks will be helpful to people with a certain condition. The scientist performs tests on that compound in the lab and frequently on mice or other animals to show that it might have help. Other scientists get involved and review the information (or in some cases perform similar tests) to help prove the theory. If that is successful then the information is presented (by a pharmaceutical company) in an application to the U.S. Food and Drug Administration (FDA). The company must gain approval from the FDA to start testing the product (called a clinical trial) in humans. This is where Oregon Medical Research Center gets involved. Clinical research trials are used to test and evaluate investigational drugs and treatments. A new investigational drug or treatment must be shown to be both safe and effective before it can be considered for approval by the U.S. Food and Drug Administration (FDA). Drug companies rely on clinical research companies like Oregon Medical Research Center to conduct the studies. A carefully monitored clinical research trial is the best way to find out if a new treatment is safe, effective, or better than medications that are already available.

The FDA has very exacting rules on how studies must be developed and patient safety is the most important consideration. Clinical trials are highly regulated and monitored. At Oregon Medical Research Center, we have been involved with more than 350 clinical trials.

11) Who should consider clinical trials and why?

It is important to test drugs and medical products in the people they are meant to help. It is also important to conduct research in a variety of people because different people may respond differently to treatments. FDA seeks to ensure that people of different ages, races, ethnic groups, and genders are included in clinical trials.

Some people participate in clinical trials because they have exhausted standard (approved) treatment options – which either did not work for them, or they were unable to tolerate certain side effects. Clinical trials may provide another option when standard therapy has failed.

Other people participate in trials because the want to contribute to the advancement of medical knowledge.

For each clinical trial, researchers develop eligibility criteria, such as the age, sex, type and stage of disease, previous treatment history, and other medical conditions. These criteria help to reduce the amount of variation in the study, without threatening the scientific integrity of the trial, by removing medical variations that might complicate analyzing the results.

Not everyone who applies for a clinical trial will be accepted. Volunteers may be excluded based on the eligibility criteria and/or the number of participants needed by the researchers to collect enough information to determine the safety and effectiveness of a therapeutic agent.

12) What’s the role of the FDA in approving new drugs & medical treatments?

The Food and Drug Administration’s job is to make sure medical treatments are safe and effective for people to use. However, FDA does not develop new therapies, or conduct the clinical trials to demonstrate safety and effectiveness. FDA staff members meet with researchers, and perform inspections of clinical trial study sites to protect the rights of participants and to verify the quality and integrity of the data.

Here are some additional links to learn more about clinical trials:

http://clinicaltrials.gov/ct2/about-studies

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm

http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm