Patient Information

Envision Research manages clinical trials and enrolls patients based on the individual’s healthcare needs and eligibility.

Frequently Asked Questions

Are you interested in participating in a clinical trial? Here is how you could benefit:

 

  • Access to new, alternative treatments.
  • Participating may help contribute to improved healthcare of future generations.
  • Receiving expert, professional medical care from your doctor’s team as well as the research study team.

Current clinical trials:

ORDA Patient Diagram Image

Below is a FAQ section that will answer questions you may have regarding clinical trials.

Have more questions? Call or email Pepper Lumina, CCRP Clinical Research Coordinator

Click to expand each of the  following Frequently Asked Questions

What is a clinical trial?

A clinical trial is a well-planned scientific study of how a medication, device, treatment, or diagnostic method affects a person. Clinical trials determine whether these are safe and effective to improve human health and well-being. Participation in a clinical trial is voluntary. Clinical trials are conducted under strict federal regulatory standards to ensure the welfare and rights of participants. Clinical trials are required by the Food and Drug Administration (FDA) before a medication or device can be used by the public.

Different Phases of Clinical Trials
Clinical trials related to drugs are classified into four phases. The trials at each phase have a different purpose and help scientists answer different questions:
A Phase I trial tests an experimental treatment on a small group of people, to judge its safety and side effects, and to find the correct drug dosage. Sometimes, the study is in healthy people and sometimes the study is in people with a disease or condition.
A Phase II trial uses more people than a Phase I to find out if the experimental treatment is effective and safe. This phase can last several years.
A Phase III trial is usually a large study with many participants. This phase compares the experimental drug or procedure to a placebo or standard treatment, to make sure it is safe and works well. Some side effects that didn’t show up in Phase II may show up in a Phase III trial because many more people are tested. The U.S. Food and Drug Administration (FDA) will consider the results of clinical trials when determining whether to approve a new drug.
A Phase IV trial takes place after the U.S. Food and Drug Administration (FDA) approves use of a drug. A drug’s effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.

Volunteering – Why should I join?

A person volunteers to participate in a clinical trial for different reasons. Examples are:

  • Suffering from a disease with no existing treatment while the clinical trial gives them an option for treatment.
  • Having used existing therapies that failed to adequately help, looks forward to new treatments.
  • Prefers the study-related individualized medical care.
  • Participating in the research may help other people in the future by advancing medical science and health care treatments.

When considering volunteering for a clinical trial, it is important to ask your physician any concerns you may have. The Envision Research team is also available for questions. The risks and benefits associated with participating in a clinical trial will be explained so that you – the volunteer – can make an informed decision.

What are my rights as a clinical trial participant?

Participation in a clinical trial is voluntary. Clinical trials are conducted under strict federal regulatory standards to ensure the welfare and protect the rights of participants.

  • You have the right to informed consent (See below).
  • You have the right to not take part in a clinical trial.
  • You have the right to leave the clinical trial at any time.
  • You have the right to be updated with readily available new information about the clinical trial.
  • You have the right to ask questions at any time and have them answered in a timely manner.

Before you decide whether to enroll in a clinical trial, a doctor or an Envision Research study coordinator will give you the informed consent form that presents the key facts of the study. “Informed consent” is the process of giving a clinical trial participant the facts about a trial. Informed consent includes details about the treatments and tests you may receive and the benefits and risks they may have.

If you agree to take part in the trial, you’ll be asked to sign the informed consent form. You can and should ask questions about the trial to make sure you understand what’s involved. Here are some questions to ask before enrolling in a clinical trial:

  • What is the purpose of the study?
  • Who is sponsoring the study, and who has reviewed and approved it?
  • What kinds of tests, medicines, surgery, or devices are involved? Are any procedures painful?
  • What are the possible risks, side effects, and benefits of taking part in the study?
  • How might this trial affect my daily life? Will I have to be in the hospital?
  • How long will the trial last?
  • Will all tests and treatments I receive be paid by the sponsor?
  • Will I be reimbursed for other expenses (for example, travel and child care)?
  • Who will oversee my care?
  • What will happen after the trial?
How am I protected while participating in a clinical trial?

Clinical trials go through several phases of regulatory approval before they are conducted at a physician’s practice.

Participant safety is guarded through the Office of Human Research Protections at the U.S. Department of Health and Human Services (DHHS), and by an Institutional Review Board (IRB), both of which are responsible for making sure clinical trials are conducted per strict federal regulations.

Envision Research and physician researchers are highly skilled and experienced.  In addition to medical and scientific degrees, these professionals have pursued training and certification specifically in clinical trial management to ensure participants’ welfare and rights.

Your health and safety are of paramount importance in a clinical trial. The clinical trial investigator and Envision research team will observe you closely. You will have scheduled periodic visits to monitor your progress while in the clinical trial.

What are the benefits and risks of being in a clinical trial?

The risks, benefits, and alternative treatments are explained and outlined in your informed consent form. You will be choosing to take an active role in your healthcare.

Examples of benefits may include:

  • Access to new, alternative treatments.
  • Participating may help contribute to improved healthcare of future generations.
  • Receiving expert, professional medical care from your doctor’s team as well as the research study team.

Examples of risks may include:

  • Unpleasant, serious, or life-threatening side-effects to the medicine, device, or treatment that you are using in a clinical trial. You will be given the appropriate care for your health and safety.
  • Treatment may be ineffective.
  • Research study may be time-consuming.
Who can participate in a clinical trial?

Your doctor and the Envision Research team will help you determine if you qualify for a clinical trial. Each clinical trial has specific criteria for who can participate. Criteria may be based on factors such as gender, age, type of disease, stage of disease and previous medical history.