Posts Tagged ‘phases of clinical trials’

Understanding Clinical Trials – Part 4: What Questions Should You Ask Before Enrolling in a Clinical Trial?

Clinical Trials QuestionsParticipation in clinical trials is 100% voluntary. While there are many benefits to participating in clinical trials, there can also be risks. If you have been offered a clinical trial, or are considering participating, it is important to talk with your physician before enrolling in one. Your health care team wants to make sure you have all the information needed to make a decision.

Do not hesitate to ask any questions or bring up any issues concerning the trial with the research team associated with the clinical trial. Tips for asking about clinical trials include:

  • Take a family member or caregiver with you for support and for help in asking questions and recording answers.
  • Plan questions ahead of time — you can still ask new questions you think of while you’re there, but it helps to be prepared ahead of time.
  • Write down your questions in advance, to make sure you remember to ask them all.
  • Write down the answers, so that you can review them whenever you want.

The National Institutes of Health (NIH) developed a list of suggestions that may be helpful to review as you think about the questions you may have:

Questions about the Study

  • What is the purpose?
  • Why do researchers think the approach may be effective?
  • Who will fund the study?
  • Who has reviewed and approved the study?
  • How are study results and safety of participants being checked?
  • How long will the study last?
  • What will my responsibilities be if I participate?

Questions about Possible Risks/Benefits

  • What are my possible short-term benefits?
  • What are my possible long-term benefits?
  • What are my short-term risks, such as side effects?
  • What are my possible long-term risks?
  • What other options do people with my disease have?
  • How do the possible risks and benefits of this trial compare with those options?

Questions about Participation and Care

  • What kinds of therapies, procedures and /or tests will I have during the trial?
  • Will they hurt, and if so, for how long?
  • How do the tests in the study compare with those I would have outside of the trial?
  • Will I be able to take my regular medications while in the clinical trial?
  • Where will I have my medical care?
  • Who will be in charge of my care?

Questions about Personal Health Issues

  • How could being in this study affect my daily life?
  • Can I talk to other people in the study?

Questions about Financial Issues

  • Will I have to pay for any part of the trial such as tests or the study drug?
  • If so, what will the charges likely be?
  • What is my health insurance likely to cover?
  • Who can help answer any questions from my insurance company or health plan?
  • Will there be any travel or child care costs that I need to consider while I am in the trial?

At Emory Healthcare, our physicians and researchers want to answer all your questions about clinical trials and research. View some of our frequently asked questions, or hear from our patients who have gone through clinical trials.

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Understanding Clinical Trials – Part 3: What are the Phases of Clinical Trials?

Phases of Clinical TrialsThe goal of clinical trials is to determine if new treatments, drugs and care-delivery processes are safe and effective. Discovery and data collected from clinical research studies impacts patient care, here and now, while also informing future generations with the hope of achieving better outcomes. But clinical studies do not happen overnight, and in fact, some take years to yield enough information to answer specific questions they are designed to answer.

Clinical trials take place in “phases,” and each phase helps researchers answer specific questions. Learn more about the different phases of clinical trials below:

Phase I:

These trials are used to test brand new drugs, devices or procedures to find out how safe they are, including safest dose, and identify possible side effects. They usually involve 20 to 80 people.

Phase II:

These trials are used to further evaluate the effectiveness of a drug, device or procedure. The researchers keep track of any medical benefits, as well as side effects. They usually involve 100 to 300 people. At the end of Phase II trials, the U.S. Food and Drug Administration (FDA) and trial sponsors determine how Phase III trials will be conducted.

Phase III:

These trials compare a new treatment or procedure to current treatments to figure out which works better. Safety and level of effectiveness continued to be monitored, as well as side effects. They usually involve 1,000 to 8,000 people.

Phase IV:

Once a drug or procedure is approved by the FDA and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment. Information is gathered on the drug’s long-term effectiveness in various populations, as well as adverse side effects associated with long-term use. In the video below, Dr. Donald Harvey walks through the different phases of cancer-specific clinical trials.

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