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We understand the many complexities behind clinical trials, and at 1nHealth, we’re here to help. Below you will find the most common questions asked, as well as basic information as it pertains to clinical trials.
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are the safest and most effective way to find new methods of preventing, diagnosing, and treating a wide range of diseases and conditions.
There are many potential benefits to be derived from clinical trials. To name a few: you will have access to the most up-to-date care, you will be evaluated by experts who will carefully track your treatment and its implications, you will be closely monitored for any side effects, and you may be making a valuable contribution to advancements in the medical field.
Every clinical trial 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.
IRB includes doctors, nurses, statisticians, community advocates, and others who make sure that each clinical trial is ethical and that your rights are protected. All institutions that conduct or support biomedical research involving people must, by federal regulation, have an IRB that approves and periodically reviews the research to ensure your safety.
Once the trial is approved by the IRB, the organizers of the study must follow a careful plan, called a protocol, that describes exactly what will happen during the study. You will know the full details of the protocol prior to joining any clinical trial.
Not necessarily. Clinical trials can be conducted in an array of settings, including local hospitals, doctor’s offices, universities, and even community clinics – the setting just depends on who is organizing the study.
Clinical trials are carried out according to a detailed plan called a protocol. The protocol will explain the purpose of the study, list the schedule of tests and procedures, delve into the potential risks and protections against such, give the length of the study, discuss eligibility requirements, and disclose the type of information the trial was designed to gather. Each participant must agree to the stipulations spelled out in the protocol before testing can commence.
The research team should be able to provide you with information about side effects and safety issues that have come up during the trial so far.
Clinical trials are usually conducted in a series of steps, called “phases.” Each phase is designed to answer a separate research question. Phase 1 trials evaluate safety. Phase II trials measure effectiveness. Phase III trials test the new drug against the best existing treatment (often referred to as the standard of care). Phase IV trials are conducted to further evaluate new uses or long-term effects of the treatment.
In many clinical trials one group of patients will be given an experimental drug or treatment; a control group consists of participants who will not receive the treatment. By doing so, the effectiveness of the treatment can be observed. here is often a misconception that the control group gets a placebo, however, most trial do not actually utilize a placebo and will never put a patient at risk by not supplying an effective treatment for their condition.
A randomized clinical trial is a study in which the participants are assigned by chance to separate groups to compare different treatment types. Neither the researchers now the participants choose which group the patient is entered. Patients are randomly assigned to either a standard treatment group (control group) or to an investigational group(s). These separate groups are referred to as the “arms” of the trial.
In a blinded trial, participants are randomly assigned to receive the test product, or an existing, approved therapy, and they are not told which treatment they are receiving. In a “double-blinded” study, neither the doctor not the patient knows who is getting the experimental treatment and who is getting the existing standard of care. It is another method used to prevent bias in research.
In open, or unblinded trials, both doctors and participants know what treatments are being given. This is the case for trials of surgical procedures or medical devices.
Before enrolling in a trial, you will receive pertinent information from the research staff. This will allow you to learn the key facts about the trial, including any/all risks and benefits, before determining whither you will participate. “Informed consent” is a term used to describe the process in which you learn such information, ask related questions, and ultimately sign a written agreement explaining that the following are true: you’ve been told the purpose of the trial, what treatments are being used, they type of data that will be collected, and how that data will be used. The purpose of informed consent is to protect participants by giving them information that can help them make informed choices about whether to take part in the trial.
No. Personal information is private and protected, only accessible to those very few with access in order to enroll you in the study applied for. Information is not sold to third parties or given to sponsors.