By volunteering, participants are an important factor in the future of medicine allowing themselves and others with the same health issues to benefit from new and advanced therapy options.
Innovative Clinical Research Center, Inc.
Links to more information and the benefits of Clinical Research trials:
https://clinicaltrials.gov/ - ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.
https://www.nih.gov/health-information/nih-clinical-research-trials-you/basics - The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency — making important discoveries that improve health and save lives.
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For additional information about the clinical trials currently enrolling at one of our Innovative Clinical Research Center, Inc. sites, please call our Study Team at 704-321-4488.
What is Clinical Research?
A clinical research study or trial is a scientific investigation to determine how or verify if a new medication, medical device or treatment works in people. It is through clinical trials that doctors can find new and better ways to diagnose, treat, control and prevent illnesses. Clinical research studies are an important part of the advancement of medicine.
Why Should I Volunteer to Participate in a Clinical Trial?
There are a number of reasons why people decide to volunteer to be in clinical trials. For some people, being a part of the advancement of science and the contribution to that it makes to society is reason enough. Others suffer from conditions for which no treatment exists or the currently approved treatment could stand to be improved upon. Most volunteers get involved to learn more about their own condition through screening examinations and evaluations throughout the clinical trial. In addition to the reasons listed above, participants can potentially receive promising new treatments at no cost to them, before they are available to the general public.
How Do I Know if a Clinical Trial is Safe?
There may be some risks to participants in a clinical trial. However, the Food and Drug Administration (FDA) has mandatory safeguards and regulations that they require all doctors (Investigators) involved in clinical trials to follow. Our doctors are committed to following all FDA guidelines in order to ensure that a person's safety is not put at risk. In addition, all clinical trials must be approved by an objective group of independent experts known as an Institutional Review Board (IRB). The IRB reviews and approves the study design and monitors the trial's progress to ensure that the risks to participants are as low as possible and worth the potential benefits of participating.
How do trials benefit the Volunteer?
You may help others by contributing to medical research. You may also gain access to help new treatments which are not available.
Who can be in a Clinical Trial?
Healthy volunteers and volunteers with a specific condition are both required in the clinical trial process.
Trained clinicians review some personal information, current medications, and medical history to determine if a volunteer may qualify. Once preliminary criteria is met more testing is completed to ensure a volunteer is a good candidate for participation.
Qualified participants receive medication and care at no cost. Reimbursement for time and study related travel may also be available.
What is Informed Consent?
"Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject's decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form." (ICH E6: GCP Guidelines; 1.28) As Investigators we take our responsibility to provide you with all of the information that you need to make an informed decision very seriously. If there is a study that you may qualify for, you will be presented with an Informed Consent Form containing this information prior to any study related procedures taking place. If new information about your trial becomes available, you will be provided with that information and be presented with a new, updated Informed Consent Form. We understand that informed consent is an ongoing process and you have the right to withdraw your consent at any time.
Who Pays for Clinical Trials?
Clinical Trials are usually sponsored by either the federal government (through the National Institute of Health or NIH), pharmaceutical companies or by device manufacturers. The investigator is reimbursed for all study related procedures through grants by the sponsoring entity.
We encourage you to ask questions. We want you to feel confident and secure in your decision to participate throughout the study. Make sure that you know the answers to the following questions before making your decision:
What is the purpose of the study?
How will I benefit from the study?
What are the risks and what are the chances that they will occur?
What discomforts are involved?
How much time is involved?
Are there other inconveniences?
Have I discussed participation in the study with those who are important to me, such as family and friends?
Phase I studies assess the safety of a drug or device. This initial phase of testing, which can take several months to complete, usually includes a small number of healthy volunteers (20 to 100), who are generally paid for participating in the study. The study is designed to determine the effects of the drug or device on humans including how it is absorbed, metabolized, and excreted. This phase also investigates the side effects that occur as dosage levels are increased. About 70% of experimental drugs pass this phase of testing.
Phase II studies test the efficacy of a drug or device. This second phase of testing can last from several months to two years, and involves up to several hundred patients. Most phase II studies are randomized trials where one group of patients receives the experimental drug, while a second "control" group receives a standard treatment or placebo. Often these studies are "blinded" which means that neither the patients nor the researchers know who has received the experimental drug. This allows investigators to provide the pharmaceutical company and the FDA with comparative information about the relative safety and effectiveness of the new drug. About one-third of experimental drugs successfully complete both Phase I and Phase II studies.
Phase III studies involve randomized and blind testing in several hundred to several thousand patients. This large-scale testing, which can last several years, provides the pharmaceutical company and the FDA with a more thorough understanding of the effectiveness of the drug or device, the benefits and the range of possible adverse reactions. 70% to 90% of drugs that enter Phase III studies successfully complete this phase of testing. Once Phase III is complete, a pharmaceutical company can request FDA approval for marketing the drug.
Phase IV studies, often called Post Marketing Surveillance Trials, are conducted after a drug or device has been approved for consumer sale. Pharmaceutical companies have several objectives at this stage: (1) to compare a drug with other drugs already in the market; (2) to monitor a drug's long-term effectiveness and impact on a patient's quality of life; and (3) to determine the cost-effectiveness of a drug therapy relative to other traditional and new therapies. Phase IV studies can result in a drug or device being taken off the market or restrictions of use could be placed on the product depending on the findings in the study.