We understand that you may have a lot of questions about clinical studies. Don’t worry. We’re here to help. We’ll provide all the information you need to make the decision that is right for you.
Following are some of the most commonly asked questions we receive about clinical studies:
Clinical research is part of healthcare science that collects evidence to establish a treatment. If you have ever taken any medication at all, then you have sampled clinical research. Research had to be done on that medication before it was available to you and others.The research is used to find medications for prevention, treatment, diagnosis or relieving symptoms of a disease. The term clinical research can be interchanged with the terms clinical study, clinical trial, research trial, research study or drug study–they all mean the same. At NCCR, clinical research often involves the study of asthma, allergy or COPD medications, but can involve medications for other diagnoses as well.
A clinical trial is a research study conducted with people. The trial evaluates a new medical treatment, drug or device. The study might be looking at the safety of a drug or device. It might be comparing treatments that already exist to see which is better. The trial might look at different ways to use an established treatment to make it more effective or if the treatment could be used in a different population. Before the Food and Drug Administration (FDA) approves a trial to begin, scientists perform testing to ensure the safety of the product in humans.
There are a variety of reasons why people choose to participate in clinical research. Those reasons include wanting to help others or wanting to help science advance. Some want to possibly receive the newest treatment available and/or gain access to quality medical care. Some feel their current treatment is not working. Others want to improve and educate themselves about their health. Some are interested because a person they trust recommended studies to them. Compensation for time and travel is an incentive to others. Most of our patients have a positive experience from their study for at least some of the listed reasons and return for further studies.
Each specific trial has its own set of rules to follow. These rules are called the protocol for the study. It spells out what type of patients can be in the study, what procedures will be done in the study, what medications are involved and the length of participation in the study. This protocol will determine who can potentially be in the study, and what criteria need to be met before beginning the screening process. Some studies are looking for healthy volunteers only. For those studies, you do not need to have any diagnosis.
The process begins with an email to us, a phone call to our office at 919-881-0309 or by visiting this link on our website to submit your information. Someone will connect with you to ask about your medical history and ask a few questions. If you continue to be interested and the staff member feels you are a potential candidate, an appointment will be made for you to come to the office and have a pre-screening visit in most situations. This initial visit lasts about two hours and involves a few procedures that could include signing consent for us to perform procedures, height, weight, ECG, blood pressure and measuring lung volume by blowing into a machine. Depending on the results of that visit, every effort will be made to find a study as soon as possible.
There are no costs to participants in our trials. For most studies, there is paid compensation for time and travel. That compensation varies from study to study.
No, insurance coverage is not necessary. We do not bill your insurance company for any part of the research study.
Informed consent is learning the key facts about a clinical study. It involves two parts–the document and the process. The document is a summary of the study including the purpose, procedures involved, the schedule, potential risks and benefits, alternative treatment options and the explanation of the participant’s rights. If you choose to enter a trial, you give your official consent by signing the document. The process is ongoing from the start to finish of your participation in the study. A member of the research team will discuss the study with you prior to signing, answer all your questions, and you will be given a copy of the signed consent. You will be updated on any new information that could affect you during the study. A member of the research team will be available to answer questions before, during and after the study.
Some questions that you might want to consider asking about a particular study would include:
- What is the purpose of the study?
- What are the risks?
- What are the benefits? What is the chance of receiving a placebo instead of the drug?
- How will I know if I am eligible?
- If I am receiving compensation, how am I paid?
- What are my responsibilities in the study?
- What happens at the first visit?
- Do I have to remain at NCCR for the entire visit?
- What can I bring with me to the visits?
- Who do I call if I have a question or concern?
- What procedures will be done during the study?
- How many visits are there?
- Can I take my regular medications during the study?
Your records of being in a study will be kept private except when ordered by law. The following people will have access to your study records: the Investigator; the Sponsor company or research institution (including monitors and auditors); the US Food and Drug Administration (FDA); other state or federal regulatory agencies; and the IRB. An IRB is an independent committee comprised of physicians, scientists, clergy, nurses, social workers, patient advocates or regular healthcare consumers. Their main purpose is to review and ensure protection of the safety, rights and welfare of human subjects in clinical research studies. An IRB may inspect and copy your records, which may have your name on them. Therefore, total confidentiality cannot be guaranteed. If the study results are presented at meetings or printed in publications, your name will not be used.
All studies are voluntary. Any participant can choose to stop study participation at any time. Risks involved with study participation include the treatment not being effective or receiving a placebo (no active drug), an adverse reaction from the treatment, an uncomfortable procedure (such as a blood draw) or the demands of the trial visits.
Absolutely. NCCR does not want to replace your relationships with your doctors. We will work with you and will, with your permission, send any information to your physician.