FREQUENTLY ASKED QUESTIONS​​

Advancements in research lead to advances in medicine.

  1. 1
    What is clinical research?
    Clinical research is research conducted with human subjects, or material of human origin, in which the researcher directly interacts with human subjects. Clinical research helps doctors and researchers to find new and better ways to understand, detect, control, and treat illness. A clinical research study is a way to find answers to difficult scientific or health questions.
  2. 1
    What is a clinical trial?
    A clinical trial is a type of clinical research study. A clinical trial is an experiment designed to answer specific questions about possible new treatments or new ways of using existing (known) treatments. They are done to determine whether new drugs or treatments are safe and effective. Clinical trials are part of a long, careful process which may take many years to complete. First, doctors study a new treatment in the lab. Then they often study the treatment in animals. If a new treatment shows promise, doctors then test the treatment in people via a clinical trial.
  3. 2
    What is a protocol?
    All clinical studies are based on a set of rules or directions called a protocol. A protocol describes what types of people are eligible to participate in the study; determines the schedule of tests, procedures, medications, and dosages; and sets the length of the study.
  4. 3
    What is an informed consent form?
    Informed consent is the process of learning the key facts about a clinical trial before deciding whether to participate. To help someone decide whether to participate, the doctors and nurses involved in the trial explain the details of the study. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.
  5. 4
    What are the phases of clinical trials?
    Clinical trials are conducted in phases. The trials at each phase have a different purpose and help researchers answer different questions: • In Phase I trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects. • In Phase II trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety. • In Phase III trials, the study drug or treatment is given to large groups of people (1,000-3,000) 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. • In Phase IV trials, post marketing studies delineate additional information including the drug’s risks, benefits, and optimal use. Most of the time, when you take part in a clinical trial, you will only be in that one phase of the study. Treatments move through the phases, but patients do not.
  6. 5
    What will be expected of me?
    The clinical trial process varies with each study. Health care professionals check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch for a time after the trial is completed. For all types of trials, the participant works with a research team. Patients come in for visits with study coordinators in which the coordinators may take vitals, collect blood and urine samples, perform study specific procedures, or dispense medication. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.
  7. 6
    Will there be any cost to me?
    In almost all studies conducted at Cherry Creek Family Practice there is no cost to the patient for participation. The sponsor may compensate study participants for their time and travel expenses and, in some instances, for the inconvenience of a procedure. There are standard compensation rates for the participant's time; the study's principal investigator determines inconvenience rates. You may still be required to maintain and pay for your existing medications. The protocol may require more of your time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.
  8. 8
    How do I benefit from participating?
    Eligible participants in a clinical research study can experience a wide range of benefits including: •Playing an active and central role in your own healthcare •Often background medications and tests are provided at no cost •Free study drug that may help improve your condition •Knowledge that you are helping others by contributing to medical research •Access to personalized expert medical care w/ frequent one-on-one doctor consultations •Developing a working relationship with coordinators who will keep you in mind for future studies
  9. 8
    Is it safe?
    The ethical and legal codes that govern medical practice also apply to clinical trials. In addition, most clinical research is federally regulated with built in safeguards to protect the participants. The trial follows a carefully controlled protocol, and as a clinical trial progresses, researchers report the results of the trial at scientific meetings, to medical journals, and to various government agencies. Individual participants’ names will remain secret and will not be mentioned in these reports. Most clinical studies pose risks of minor discomfort, lasting only a short time. Some volunteer subjects, however, experience complications that require medical attention. The specific risks associated with any research protocol are described in detail in the consent document, which you are asked to sign before taking part in research. Risks to consider include: • Side effects may be worse than those of the current treatment. • Side effects may occur that the doctor does not expect. • New treatments do not always turn out to be better than, or even as good as, standard treatment. • As with standard treatment, the new treatment may not work for you even if it works for other patients.
  10. 9
    What if I want to drop out of a trial?
    All participants in clinical trials are volunteers. You can choose to quit a clinical trial at any time, but talk to your doctor first. Your doctor can tell you how quitting the trial might affect your health and if there are other treatment options. Your relationship with your health care providers will not be changed by your decision.
  11. 10
    How do I know if I qualify?
    All trials are different – give us a call and we’ll let you know! (720) 240 - 0317.