Volunteering to participate in a clinical trial is truly something to feel good about. Every study participant makes a valuable contribution to healthcare and to patients suffering from disease worldwide.
At NewLab Clinical Research, patient safety and comfort is our top priority. We hope that these pages help to answer some of your questions about clinical research. Please feel free to call us at any time if you would like to speak to one of our healthcare professionals or arrange for a personal visit.
Please click her to view our current clinical trials
What are Clinical Trials?
Clinical trials are human research studies designed to answer specific scientific questions. Although there are many different types of clinical trials, they all share the common goal of improving prevention, diagnosis or treatment of medical conditions. For a new drug to be approved, the results of carefully conducted clinical trials in a number of healthy people and patients are analyzed to determine if the benefits of taking the drug outweigh the risks. Clinical trials are normally done in four phases to evaluate the risks and benefits of the product. The following table provides an overview of each type of trial.
Phase I
The first tests of the drug in people. They look mainly at a drug’s safety and are usually done in a small number of healthy patients which typically takes several months and may require close observation. Phase I patients do not necessarily have the target disorder of the treatment. Due to the special needs and facilities required for successful Phase I trials, NewLab Clinical Research does not yet participate in this type of research.
Phase II
Tests the drug in patients who have the disease that the drug is expected to improve. They evaluate both the effectiveness and safety of the drug and include more patients than Phase I studies. These trials are usually double-blinded with placebo controls (neither the investigator nor patient know if the patient is receiving active drug or not). This phase can last up to two years.
Phase III
Similar to phase II studies except they usually involve a large number of patients ranging from hundreds to several thousands. Because phase I and II trials have already established the safety of the candidate drug, the risks of Phase III trials are minimal. Once a drug passes a Phase III trial, the company that developed it can apply for approval to market the drug.
Phase IV
Also called ´post-marketing studies´ or registries as they are conducted after the new treatment has been approved and is being marketed. These are usually long term studies that are used to evaluate the long term benefits or side effects in a larger number of people.
Why should I volunteer?
Participants in clinical trials can play a more active role in their own health care. Your health will be monitored in great detail throughout your participation in the trial, all at no cost to you. As a study participant, you will also gain access to new medical treatments for your condition which may (or may not) be better than standard treatments. Most importantly, by volunteering for a clinical trial you are making an important contribution to society, as you will help us learn how to help people in need. It is truly something to feel good about.
Your rights and responsibilities
As a research volunteer, your rights, safety and well-being are NewLab’s first priority, and they are protected and upheld by an international set of standards known as "Good Clinical Practice". Study participants have the right to be fully informed about the nature of the study and what is expected of them, including the foreseeable risks and potential benefits to them. It is important to take all the time that you need to decide whether or not to participate, and be sure that your questions are answered to your satisfaction. You will not be pressured to participate in research, and your medical care is in no way associated with your decision to become a volunteer. In any study, you can change your mind and decide to withdraw your consent at any time.
Once you have a clear understanding of what the trial involves and you consent to become a part of it, it is very important that you follow the directions of the nurses and physicians as closely as possible. You must also be sure to attend all of your study appointments, or reschedule them as far in advance as possible if needed. These responsibilities should not be taken lightly, as the quality of medical research is highly dependent on everyone following the study procedures.
What to expect
NewLab's team of physicians, nurses and support staff are here to facilitate your participation in the important job of research volunteer. A nurse coordinator will work closely with you to be sure that your questions are answered, your appointments are scheduled, and that you are comfortable with all of the study procedures.
There are as many different types of trials as there are diseases to treat, but some basic principles apply to most of them:
- The plan for the clinical trial is contained in a protocol, which is carefully designed to answer specific research questions and to safeguard the health of its participants above all.
- In many clinical trials, one group of patients will be given an experimental drug or treatment, while the control group is given either a standard treatment for the illness or a placebo. The choice of who will be in which group is completely random. You should talk to the research staff about how this randomization works and what are the risks and benefits to participation in this kind of trial.
- Every clinical trial in the world must be approved by an independent ethics committee to ensure that the rights, safety and well-being of study participants are protected at all times.
You will receive a summary of the clinical trial in the document known as the “informed consent form”. Once you have reviewed the form, you may be ready to schedule a visit at the research clinic, or you may have questions about the study – in either case, you are invited to call NewLab Clinical Research at any time and our Patient Relations Manager will direct your call appropriately. The first visit in a clinical trial is called a “screening visit”, and it consists of a review of the informed consent form as well as a series of tests to ensure that you meet the very specific medical criteria specified in the study protocol. The screening visit includes a review of your medical history and the details of the condition to be studied in the clinical trial. We will also ask you about other health conditions and medications you may be taking. The screening visit also usually includes blood or urine tests, a physical exam, other procedures and questionnaires.
If you are chosen to participate in the study, we will schedule your first day of treatment and a series of visits and assessments at NewLab Clinical Research. The number of visits will vary between studies, and all are described in the informed consent form.
Throughout your participation in a study, communication is critical. NewLab's research team is always available and happy to address your questions and concerns.
|
|
|
|
|