Actively recruiting patients for

CLINICAL TRIALS

We recruit patients for clinical research and trials at no cost to the patient. Our staff is well trained in “Good Clinical Practice“ aka GCP providing ethical and highest scientific quality in conducting, recording and reporting trial results. We have worked with major sponsors like GSK, Pfizer, Novatris, Johnson and Johnson, Merck and many others.

We have worked with the following Clinical Research Associates: PPD, PPDI, PRA International, I3 Research, Ingenix Pharma, Pharma Net, Premier Research, Paraexel Inc, UBC Inc, Research Point and Medpace.

SEE TRIALS IN PROGRESS

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Why Should I?

Participate in a Clinical Trial

Clinical trials are part of clinical research and at the heart of all medical advances. Clinical trials look at new ways to prevent, detect, or treat disease.

The goal of clinical trials is to determine if a new test or treatment works and is safe. Clinical trials can also look at other aspects of care, such as improving the quality of life for people with chronic illnesses.

People participate in clinical trials for a variety of reasons. Healthy volunteers say they participate to help others and to contribute to moving science forward. Participants with an illness or disease also participate to help others, but also to possibly receive the newest treatment and to have the additional care and attention from the clinical trial staff.

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Clinical Trials 101

The process is simple

Clinical trials are conducted in a series of steps, called phases – each phase is designed to answer a separate research question.

Phase I: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

Phase II: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.

Phase III: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.

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HOW ARE CLINICAL TRIALS CONDUCTED?



Browse answers to your

FREQUENTLY ASKED QUESTIONS


  • What trials can I participate in?
  • What is a clinical trial?
  • How much will it cost?
  • What is a protocol?
  • Who monitors the conduct of protocols?
  • Who gets to be in a study?
  • What is informed consent?
  • What is assent?
  • What are my rights as a research participant?
  • What should I consider before agreeing to participate?
  • What happens when the study is over?
What trials can I participate in?

Please sign up on our website for email alerts to know about upcoming and in-progress trials. Click here to download the enrollment form or read about the latest trials under the Resource Center tab.

What is a clinical trial?

Research that includes humans is clinical research. Clinical research helps researchers understand how best to treat patients or helps them learn more about a particular condition or disease. There are many different forms of clinical research. One common form is a clinical trial. In a clinical trial, researchers test new drugs, medical devices or treatments.

Clinical trials may seek to discover new drugs, new ways of giving patients approved drugs, new combinations of approved drugs, new surgical techniques, devices, or biological products. Clinical trials are also conducted to test cutting-edge and novel therapies, like studies that involve gene therapy or gene transfer.

Clinical trials must be conducted before a new drug, biologic, or device may be marketed in the United States. The FDA regulates clinical trials. The FDA gives investigators permission to test a new drug, biologic or device under strict regulatory conditions.

How much will it cost?

Clinical trials test new drugs, devices, or treatments. In some cases, taking part will not cost you or your insurance company anything. In other studies, the research team may bill your insurance company for drugs, devices, and services they provide. It is possible that your insurance company will not pay for some or all of the charges and you may receive a bill for those costs. The study informed consent form will describe any costs to you in detail. If the information in the consent form is not clear, you should ask the research team to explain any costs before you sign the consent form.

What is a protocol?

A protocol describes the rules to follow during the research. For example, a protocol states why it is important to study the research question and how the research team will answer the research question. A protocol also states how the research team will protect the health and well being of the research volunteers. A protocol includes information on the study procedures, medications to be used, possible risks and benefits, possible adverse events, and data analysis methods.

Who monitors the conduct of protocols?

Physicians, nurses, sponsors, auditors, statisticians, and federal and non-federal regulatory bodies carefully monitor the actual conduct and safety of protocols. This means that different groups are reviewing the safety and progress of each protocol on a regular basis. If any of these groups determine that there is a concern with how the study is conducted, the study will stop.

Who gets to be in a study?

Each research study is different. Each study tries to find answers to a specific question. Researchers must follow strict rules to decide who may take part in research. Not everyone with the disease or problem that is being studied can take part in a research study. If your doctor thinks that you might qualify for a study, he or she may ask if you want to take part. Many patients also look for research studies on their own through websites or support groups.

What is informed consent?

Informed consent is the process that gives information to people who are thinking about taking part in research. After learning about the research, you should understand:

  • the purpose of the study
  • the procedures involved in the study
  • the possible benefits and risks of taking part in the study
  • the rights of people who take part in research
  • that taking part in research is your choice
  • what you can do instead of taking part in the study
  • how the research team will give you any new information that may be learned after you decide to take part in a study that might cause you to change your mind

Informed consent is a process that helps you learn about the research study. After learning about the study, you will be able to ask the researcher or his/her staff questions. You should only agree to take part after you clearly understand the study and feel comfortable. You should take time to talk over your decision with your doctors, family, and friends. If you agree to take part, you will be asked to sign an “informed consent form.” The informed consent process goes on even after you are taking part in the study. If researchers learn new information after you begin the study, they must share this with you.

What is assent?

Research at Neuro Pain Medical Center includes children as well as adults. The law states that children cannot make their own decision about research. We, however, feel it is important that children but receive an explanation of the research and have a chance to ask questions. If your child’s doctor tells you that your son/daughter must “assent” to participate, it is because we respect his/her rights as a person. “Assent” refers to the process by which we ask a child’s agreement to participate. In most cases, investigators will obtain a child’s assent if he or she is over the age of 7. It is important that the information shared with your child be understandable. The researcher will consider your child’s age and maturity level when presenting information. Doctors and parents need to work together to help the child understand what a study involves.

Adults who cannot legally make decisions for themselves may also agree to participate through an assent process. Researchers must also obtain the consent of an individual who represents such. Investigators want to make sure that the person whose mental abilities are impaired has some understanding of what will happen to him/her and can say no if he/she so chooses.

Sometimes assent is not required. In situations where the research may be the only way to help a patient with a life-threatening illnesses, assent is not required if the research is expected to be beneficial to the individual. Even so, researchers are encouraged to discuss the research with the individual patient.

What are my rights as a research participant?
  • You have the right to not take part in a research study.
  • You have the right to drop out at anytime.
  • You have the right to be given new information about the study.
  • You have the right to ask questions at any time and have them answered as soon as possible.

You also have the responsibility to stay informed during your participation in a study. You should ask questions about anything you do not understand or simply want to know.

What should I consider before agreeing to participate?

You may consider taking part in a study because:

  • You may benefit from the best possible treatment or an experimental treatment that would otherwise not be available to you.
  • The physicians and nurses will closely monitor your progress throughout the trial.
  • You would be helping researchers to improve the treatments for future patients.

You might consider not taking part in a study because:

  • The experimental treatment may not work for you, or it could make your condition worse.
  • The experimental treatment may cause side effects that no one anticipated.
  • Your health insurance may not cover research procedures.
  • If the trial is randomized and includes a placebo (an inactive, dummy pill), you may not be given the experimental treatment.
  • The amount of testing for efficacy and safety purposes may involve too many trips to the research office and take too much time.

When deciding whether or not to participate, you should ask the following questions and you should feel comfortable with the answers:

  • If I am ill, will this research help me?
  • What are the risks?
  • What is involved? What will I have to do?
  • Will I be charged anything or compensated for my participation?
  • How can I end my participation if I change my mind?
  • What will happen when the study is over? Will I be told the results?
  • Is the study controversial?
  • Whom do I contact to express concerns or obtain information?
What happens when the study is over?

At the end of a study, the researchers analyze the data that were collected from all participants throughout the study. Findings and data collected about you will be compared to other participants. In clinical trials, doctors and specialists in biostatistics would conduct the analysis and report the findings to scientific meetings and medical journals. Data will also be shared with experts and various government agencies responsible for the approval of new drugs, biologics and devices. Not all experimental treatments receive final FDA approval in the end.

What happens when the study is over also varies from study to study. Sometimes patients can remain on the study drug if they are responding to the new treatment; however, this is the exception rather than the rule. Generally, participation ends when the study ends because it might not be safe or effective to continue treatment based on what is known at the time. Clinical trial participants can withdraw from the study at any time without jeopardizing the rest of their standard medical care.

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