Some people mistakenly believe that because a clinical trial is listed at the National Institute of Health’s sponsored website, www.ClinicalTrials.gov that the study is approved by the United States government.  Deciding to participate in a clinical trial requires some knowledge and understanding of how clinical trials work.

Who Is Sponsoring the Clinical Trial

It is important to know who is sponsoring the study.  A study sponsor is the organization who not only originates and designs the study but also has authority and control over all aspects of the clinical trial. There are many different types of sponsors. Sponsors can include a pharmaceutical company, an academic medical center, a private practice or a research organization such as the American Macular Degeneration Research Foundation.  Knowing who the sponsor is will help you determine the credibility of who is initiating the study.  The National Institute of Health provides this disclaimer to remind people that it is up to them to make an informed decision:

“The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.”

Who Can Participate in a Clinical Trial

Each study will have very specific guidelines that a patient must meet in order to qualify to be in their study.  It’s much more complicated than just having a condition, such as macular degeneration or diabetic retinopathy.  Age requirements are listed for each study – one clinical trial might require patients be 50 and older and another study may have age requirement of 45 to 80 years old. Other qualifications will be listed under the heading, “Eligibility Criteria.”  Some examples of Inclusion Criteria are that only patients who have not yet started any treatment are eligible and yet another study will have specific criteria for Best Corrected Visual Acuity.  A patient may be excluded from participating in a study for many reasons and they will differ with each study.  Having an autoimmune disease, high intraocular pressure, or a history of cancer may disqualify someone.

What Does “Different Arms” Mean?

Just because someone is eligible to be in a study, it is important to be aware that some of the participants may not receive the investigative treatment.  Some studies have what’s called different “arms” or groupings.  One group may receive a placebo, or another group may receive what’s considered standard treatment.  You may see the term “sham arm” which means a group of participants receives a procedure or device that appears to be the same as the actual procedure or device being studied but does not contain active processes or components. Clinical trials are designed to reduce any preconceived biases towards or against a treatment and as a result patient are randomly assigned to an arm. Depending on how the study is designed, often the patient nor the provider know if the research drug or therapy is being administered.

Participating in a clinical trial is a big decision that requires a full awareness of what treatment you will be receiving and the possible risks and benefits.

Leslie Degner, RN, BSN

www.WebRN-MacularDegeneration.com