Taking Part in Clinical Trials FAQs

NOR's strength is dependent and built around our quality physicians and sponsor-driven staff. In order to achieve a successful collaboration with our patients and study sponsors, we feel education, communication and a complete understanding of what our patients' expectations and needs are is our first priority.

What is a clinical trial?

A clinical trial is one of the final stages of a long and careful research process. It is a research study that evaluates new treatment therapies, which focuses on ways to prevent, detect, diagnose, control and treat diseases. Such research relies on patients like yourself, who volunteer to participate in these new or changed medical therapies. These clinical trials are specifically conducted in health care settings such as a hospital or outpatient clinics by interested physicians trained to manage research. The search for new treatment therapies begin in the laboratory, where scientists first develop and test studies. If an approach seems safe and effective, the next step may include testing in animals and then in patient populations specific to the the treatment therapy.

What is the purpose of a clinical trial?

The purpose of a clinical trial/research study is to determine whether a new treatment option is safe and effective and better or comparable then the current medical standard of care. It also gives our patients the ability to participate in cutting edge medicine and allows them alternatives in treating their disease process that they would not generally have available to them.

Why are clinical trials important?

Today's clinical trials lead tomorrow's standard's of care. If a new treatment proves effective and beneficial, it may then become the accepted standard of care that will benefit many patients in the future.

How does a clinical trial differ from standard medical care?

Clinical trials test the safety and effectiveness of new treatment options. Standard medical care are treatment options that have been proven effective, approved by the FDA and are currently being utilized by physicians.

Are clinical trials safe?

Risk and side effects exist with almost any medical treatment whether it is the standard of care or as a part of a clinical trial. However, many safe-guards are in place to make sure clinical trials are as safe as possible and protect patient rights.

To assure that the sponsoring company are properly protected, most clinical trials are regulated and monitored by the federal government, the sponsoring company and by the institution where they take place. Clinical trials are headed by one or more physicians, also known as "principal investigators," who are deemed to have the capability and expertise necessary to conduct the trials. The trial may take place in one or more medical centers in the same country or throughout the world. All institutions that conduct clinical trials utilize an Institutional Review Board (IRB) - a group usually consisting of medical doctors, nurses, community leaders, attorneys and ethicists. This board must review and approve each clinical trial prior to its initiation. In addition, the IRB continually reviews all ongoing clinical trials on a regular basis and the IRB is immediately alerted to any new outcomes or adverse effects of the treatment being studied.

How are clinical trials managed?

Each clinical trial has an action plan (protocol) that explains how it will work. Known as a protocol, this plan explains what will be done in the study and why. It outlines how many people will take part in the study, what medical tests they will receive and how often, and the treatment plan. The same protocol is used by each doctor that takes part in the study.

Each study enrolls people who are alike in key ways. The protocol describes the characteristics that all patients in the study must have in common. Called eligibility or inclusion criteria, these guidelines differ from study to study, depending on the trials purpose. They may include age, gender, whether patients have had prior treatments or who have other health problems.

Using eligibility criteria is an important principle of research that helps protect patients and produce reliable results.  Patients then follow the action plan throughout the trial and once all patients enrolled have completed their participation in the study, the results are analyzed. This data is then used to help the FDA determine if this treatment option should be approved for all patients. Once approved it is an available treatment option for all physicians to prescribe.

Should you take part in a clinical trial?

Possible Benefits:

You may or may not benefit directly from participating in a clinical trial. Clinical trials offer high-quality care and potential benefits. Taking part in a clinical trial also offers participants a chance to be a part of a process that may and often does result in a significant advancement in the ongoing medical effort to discover new and effective ways to fight debilitating illnesses. To many people, that possibility in itself is sufficient motivation to take part.

Possibly Drawbacks:

New treatments being studied are not always proven to be better than, or even as good as the current standard of care. They may have side effects that doctors do not expect or that are worse than those from standard treatments. Even if a new treatment has significant benefits, it may not work for you. Even standard treatments, proven effective for many people, do not help everyone.

Who pays for clinical trials?

Cost is an important consideration for a patient thinking about entering a clinical trial. Most clinical trials that test a treatment require clinic or hospital visits, x-rays, blood tests, or other medical procedures. Often a pharmaceutical or biotechnology company sponsors the clinical trial and any extra associated costs involved; although, patients should ask if they will have any associated costs in conjunction with the study.

What is an Informed Consent?

Taking part in a clinical trial is up to you and is strictly voluntary and you have the right to discontinue your participation in a study at any time. If you are asked to take part in a trial, you will need to read thoroughly and sign a patient informed consent. The purpose of this is ensure that participants are fully aware of what is involved in the trial. You should study the consent form carefully to be sure you have a clear understanding of what to expect, including procedures, risks and benefits. Remember that participating in a clinical trial is strictly voluntary. And, if you choose not to participate, that decision will have no impact on the care you receive. Now or in the future, clinical trials are regulated by the federal government and certain sections of the consent form are standard for all clinical trials.