Frequently Asked Questions

A clinical trial is a research study involving people. They are performed to show whether a drug is safe and effective for a particular kind of patient or diagnosis.

Clinical trials differ from routine medical care because they have a specific goal to determine the effectiveness of the study medication. They are carried out under very strict protocols designed to determine the effectiveness of the study medication. Study participant’s relationship with the clinical trial doctors may be different than that of a primary care doctor. Primary care doctors have the flexibility to do whatever they think is in the patient’s best interest to promote health. Clinical trial doctors must follow the protocols designed to determine the effectiveness of the study drug.

Before new medication can be made available to the general public, it needs to be evaluated to make sure that it is safe and effective. This is achieved by carefully monitored clinical trials. The FDA (Food and Drug Administration) has established very rigorous guidelines for how pharmaceutical companies (known as “sponsors”) research the drug in healthy patients first, then in those who the drug is designed to help. Only when the results show the drug to be safe and effective can sponsors bring it to market.

Sponsors collect information in a very systematic way. Every new medication has to be approved by a variety of review boards, including the FDA. They have strict rules that the trial sponsors must follow to protect patients. Clinical trials contribute to our understanding of how a drug works, if it works and if it has a clear risk/benefit advantage.

Yes! Prior to Human clinical trials, all drugs are extensively tested in animals. Through this process we get a good understanding of their use, effectiveness and safety prior to testing in healthy humans. Then we measure the safety of the compound in an actual person who has the condition. Of course, there is no absolute guarantee that what you find in animals will also hold true in people. That is why we do so much safety monitoring during the clinical trial.

Clinical trials are designed to figure out a wide range of questions: What kinds of patients the drug might be useful for? What age range? What kind of dosing? Whether the drug is useful and safe when the patient is taking other drugs?

We perform many different evaluations such as health assessments and questionnaires to discover benefits and risks. The goal is to find out exactly what the drug will do and whom it will help.

Every clinical trial proceeds on the basis of informed consent. When you decide you’re interested in participating in the study, you are provided with written information called informed consent. It includes information on why a medication is being studied, how long the study will last and what the potential benefits/risks are for the study medication.

The clinical trials that Suburban Research Associates conducts are considered double-blinded. Double-blinded means that neither you nor Suburban Research Associates knows if you are taking the study medication or a placebo (A placebo is an inactive sugar pill).

Yes. In any clinical trial, you can leave at any time, no matter what the reason. If you decide to early terminate a clinical trial, it is very important to tell Suburban Research Associates that you are discontinuing and why. The information provided can be important for other participants and for the sponsor to get the best information out of the study. There may also be safety effects to address if you stop medication without previously informing the coordinator.

It is important to know that discontinuing a clinical trial will not cause Suburban Research Associates or your personal doctor to treat you differently, nor will it decrease your chances to get a drug or other treatment that may benefit you. There are no repercussions for early termination of a trial.

It would depend on the study drug on trial. Each clinical trial has different inclusion and exclusion criteria so always disclose ALL medications being taken to the study coordinator and doctors. This applies to over the counter medications as well.

It depends. There are study guidelines that pharmaceutical companies must follow in this matter. If there is enough safety and effectiveness of the drug, the study may have what’s called an extension. Extensions allow treatment with the study drug to continue after the main study ends. Check with your study coordinator regarding your clinical trial.

It depends, ask your coordinator. Once results are finalized and approved, Suburban Research Associates can usually discuss the findings with the participant. Keep in mind, that studies often last longer than a patient’s actual participation and then all of that data needs to be analyzed. Therefore, it can take up to a year or two before Suburban Research Associates may know the results.

*The following information is intended as educational material and has been extracted from the National Fragile X Foundation Quarterly, Issue 45, June 2012. The information and examples expressed have been provided by Suburban Research Associates and do not reflect the views or opinions of our collaborating sponsors.