What are clinical trials?

A clinical study is carefully designed to test the effects of a medication, medical treatment, or device on a group of volunteers. Clinical studies are an important step in making new medications available. They measure the drug’s ability to treat a condition, its safety and its possible side effects. Some trials involve new medications not available to the general public. Other studies focus on existing medications which are being evaluated for their effectiveness compared to other medications.

There are various stages of testing within the drug development process. At each stage, a certain critical threshold must be attained before the process can advance to the next level. In Pre-Clinical testing, medications are tested in a laboratory. Phase I, is commonly referred to as the ‘first in man’ studies and is typically conducted using 40-100 healthy volunteers in a control setting to determine safety, metabolization, duration of action, rate of excretion or possible side effects. Phase II is where the drug is given to a small group of patients that are actually suffering from the condition the drug is intended to treat. Phase III, this is the final stage of testing prior to approval and involves hundreds of patient volunteers. During this phase, patient recruitment requires close attention to detail. At the completion of this phase, the drug sponsor will assemble all the relevant data from the pre-clinical and clinical trial process and submit a New Drug Application to the FDA. Once, approval is obtained, the FDA requires pharmaceutical companies to conduct limited, post marketing or Phase IV studies, primarily to determine if there is any safety issues that arise from long-term use or interactions with other drugs taken by the real world. Generally, Five Towns Neuroscience Research conducts Phase II, III and IV trials.
Clinical trials are typically sponsored by the pharmaceutical companies, but federal agencies such as the U.S. Food and Drug Administration (FDA), universities, and medical foundations may also sponsor trials.

Who participates in clinical trials?

People with the condition being studied as well as healthy people can volunteer to participate in a clinical trial. The FDA has very strict requirements that specify which studies involve healthy volunteers and which studies involve patients with condition being studied.
Each study has specific requirements such as age, gender, or medical/psychiatric condition for participants. Initially, a research assistant will ask you basic information about your current condition and medications during a brief interview by phone or in person that will allow them to find out if you are a good candidate to participate in a clinical trial. If you qualify based on the phone screen, you will be scheduled for an appointment to speak to the doctor or nurse practitioner. During the clinical appointment the study will be discussed with you in detail and you will be given the opportunity to decide if you want to participate in the study.

In a clinical trial, what should I expect?

When you arrive at Five Towns Neuroscience Research, you will meet with the doctor and/or the nurse practitioner who are part of the research team conducting the trial. Before any person can participate in a clinical trial, they must first consent to participate by signing an Informed Consent Form. The research team is trained in medical and mental health research. They will explain everything about the trial, what to expect, and answer any questions or concerns you might have. When you make the appointment, they will tell you what to expect in the first visit.

What are the benefits of participating in clinical trials?

You have the opportunity to receive cutting edge medicine and treatment for your condition at no cost. In some cases the U.S. Food and Drug Administration has already approved the medication for other uses in the United States and the trial is being conducted to determine the effectiveness in treating a your condition. Also, in some cases, you will have the opportunity to keep receiving the medication being studied at no cost for a period of time.

What protections are there for people who participate in clinical trials?

The government has strict guidelines and safeguards to protect people who choose to participate in clinical trials. Every clinical trial in the U.S. must be approved and monitored by an Institutional Review Board (IRB) to make sure the risks are as low as possible and are worth any potential benefits.
An IRB is an independent committee of physicians, statisticians, community advocates, and others that ensures that a clinical trial is ethical and the rights of study participants are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that initially approves and periodically reviews the research.

Is the information confidential, can I stop participating at any time?

All information collected during your participation in the trial is held confidential a unique code is assigned to you that will be used on all information related to your care. At any point, if you so desire, you can withdraw from the study. That is your right.

What is informed consent?

Informed consent is the process of learning the key facts about a clinical trial before you decide whether or not to participate. These facts include:
  • Why the research is being done.
  • What the researchers want to accomplish.
  • What will be done during the trial and for how long.
  • What risks are involved in the trial.
  • What benefits can be expected from the trial.
  • What other treatments are available.
  • The fact that you have the right to leave the trial at any time.

If you are considering joining a clinical trial, the research staff will give you informed consent documents that include the details about the study. Since joining a clinical trial is an important decision, you should ask the research team any questions you may have about the study and the consent forms before you make a decision.

If you decide to join the clinical trial, you will recieve a copy of the informed consent documents so you can review them at any time.

Remember informed consent is more than signing a form. It is a process that continues through the study. You should feel free to ask the research team questions before, during, and after the study. Informed consent continues as long as you are in the study.