Posts Tagged ‘clinical trials phases’

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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Understanding Clinical Trials – Part 2: What are the Benefits of Clinical Trials?

With any clinical trial, there are both benefits and risks associated; however, clinical trials are not just for sick people, unlike common perception. Both healthy people and people with certain diseases or conditions participate in clinical trials. While some participate to receive care or treatment only available through a clinical trial, others participate to help researchers find better treatments.

For researchers, physicians and health care professionals, clinical trials are extremely important because they allow us to make real-time differences in medicine. Treatment regimens, drugs and care-delivery protocols all exist today because of clinical studies conducted in the past. Clinical trials and research provide not only hope for our patients, but a possibility for better outcomes and medical advancements in the future.

As a leading academic medical center, Emory Healthcare is proud to offer more than 1,000 clinical trials to our patients. Some direct benefits patients receive by participating in clinical trials include:

  • Access to new treatments that are not yet available to the general public
  • Access to more effective treatments than the standard care therapies
  • Close oversight from medical experts at a leading health care facility in the Southeast
  • Helping others by contributing to medical research

The decision to participate in a clinical trial is completely voluntary; therefore, to help you and your loved ones decide whether or not to participate, it is important to understand any potential risks. The known risks and benefits are different depending on the clinical trial, so make sure you talk to members of the research team before making a decision.

In the video below, Emory researchers and doctors discuss the benefits of clinical trials.

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Understanding Clinical Trials – Part 1: What are Clinical Trials?

What is a Clinical Trial

WATCH Winship at Emory patient and clinical trial participant, Holly Johnston, discuss her decision to enroll in a cancer clinical trial.

Clinical trials are an essential part of moving research forward and most medical advances have been made possible because of volunteer participation in clinical trials.

At Emory Healthcare, clinical trials are at the core of our mission where discovery and research fuel exceptional patient-and-family-centered care. But for many people, clinical studies seem complicated and intimidating. To answer some popular questions about clinical trials and clear up common misunderstandings, we are launching a six-part series on understanding clinical trials and why they are an important part of patient care.

What are clinical trials?

A clinical trial is a form of research that uses human volunteers (called participants) to answer specific questions that help doctors understand new ways to prevent, diagnose and treat diseases.

Existing treatments today may not be effective for everyone, so clinical trials help determine if new drugs, diagnostics or procedures are safe and effective before they are made widely available. There are different types of clinical trials, but all start with a question. An example question would be “does the dose of this drug impact its effectiveness?” A well-designed clinical trial is set up to provide answers to the original question.

What happens during a clinical trial?

Every clinical trial is led by a principal investigator, who is usually a medical doctor, and they typically have a research team including doctors, nurses, social workers and other members of the care team. New treatment therapies are usually tested in three separate phases before regulatory agencies consider them safe and effective.

During a clinical trial, data is collected to help inform the study outcome, which can be positive or negative. Either way, a clinical study is successful if the answer to the initial question is clear and has a solid foundation of scientific data to support it. Even if the outcome is different than the principal investigator’s hypothesis, the end result informs which direction the research team should take next.

Clinical Trials at Emory

There are more than 1,000 clinical trials underway at Emory Healthcare and the outcomes are not only making a difference in people’s lives here and now, but for generations to come.

As we continue our blog series on understanding clinical trials, we want to know what questions you have about clinical trials and clinical research. Leave your questions in the comments field below and your question may just get answered by an Emory researcher!

Also, click to see a list of frequently asked questions about clinical trials.

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Stroke Rehabilitation Clinical Trial a Top International Trial

Rehab Clinical TrialAt Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.

In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.

The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.

Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.

During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.

“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”

Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.

Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.

“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”

The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.

Click to learn more about clinical trials at Emory, or call 404-778-7777.

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Emory’s Stroke Rehabilitation Clinical Trial Chosen as Top International Trial

Rehab Clinical TrialAt Emory, clinical trials are at the core of our mission and we are proud to offer them to our patients. Groundbreaking scientific advances and medical treatments available today have been made possible because of volunteer participation in clinical trials and research.

In fact, one of the thousands of clinical trials conducted at Emory was just identified as one of the 15 top international clinical trials ever published for physical therapy and rehabilitation.

The EXCITE (Extremity Constraint-Induced Therapy Evaluation) trial, led by Emory University’s Steven Wolf, PhD, PT, professor of rehabilitation medicine at Emory University, was created to teach stroke patients to use their stroke-affected arm rather than their “good” arm. Conducted almost a decade ago, the clinical trial was found to have a significant impact in stroke rehabilitation, which set the stage for many future trials.

Each year, more than 795,000 people in the United States suffer from a stroke and many stroke survivors experience partial paralysis on one side of the body. The EXCITE trial enrolled 222 patients who had suffered a stroke, predominantly an ischemic stroke, within the previous three to nine months.

During the trial, participant’s less-impaired hand was restrained and/or immobilized by placing a mitt around the “good” arm in an effort to encourage use of the affected extremity. Participants engaged in daily repetitive tasks and behavioral therapy sessions, which included training in tasks such as opening a lock, turning a doorknob or pouring a drink. Only use of the affected arm was allowed during exercise.

“Often, stroke rehabilitation focuses on teaching patients how to better rely on their stronger limbs, even if they retain some use in the impaired limbs, creating a learned disuse,” says Wolf. “This trial was just the opposite and focused on the impaired limb, which proved to be a valuable form of rehabilitation. We are so pleased and honored that this clinical trial has been found to be a top 15 trial amongst an international jury of experts.”

Wolf, and other Emory University researchers partaking in the national trial, studied participants to determine if the intervention improved motor function, as compared to no therapy at all. Patients were evaluated using the Wolf Motor Function Test (named after Wolf), which is a measure of laboratory time, strength-based ability and quality of movement.

Research investigators found that over the course of a year from the beginning of therapy, the group undergoing constraint-induced therapy showed greater improvements than the control group in regaining function.

“Results showed that constraint-induced movement therapy produced statistically significant and clinically relevant improvements in arm motor function that persisted for at least one year at follow-up,” says Wolf. “This trial was the first large multi-center, randomized controlled trial in stroke rehabilitation that lay the ground work for many other trials to follow.”

The EXCITE trial was funded by the National Institutes of Health from 2000-2005 and the results were published in JAMA in 2006. For the past 15 years, PEDro, a database located and supported within the George Institute for Global Health in Australia, has reviewed clinical trials, guidelines and reviews of work related to rehabilitation and physical therapy. During that time period, around 28,000 trials and manuscripts dating back as far as 1929 were reviewed. The free database is used by thousands of physiotherapists and others interested in rehabilitation from more than 200 countries. Out of the 15 trials highlighted by PEDro, only two were clinical trials based in the U.S.

Click to learn more about clinical trials at Emory, or call 404-778-7777.

Related Resources

Clinical Trials – FAQs

Clinical Trials at EmoryAt Emory Healthcare, we are proud to sponsor clinical trials and offer the opportunity for our patients to participate in them. Currently there are more than 1,000 clinical trials offered throughout our health care system. As one of the nation’s leading academic medical systems, our involvement in clinical trials sets us apart from other health care organizations. Access to advanced resources and technology allows our care team to provide patients with the most effective and progressive treatments. It’s only once these treatments are approved that they’re made available elsewhere.

Medical advances and improvements to patient care have been made possible by clinical trials and the participation of volunteers. Below are answers to frequently asked questions you may have about clinical trials.

Q. What is a clinical trial?

A. A clinical trial is a form of research that uses human volunteers (called participants) to help answer specific questions about new ways to prevent, diagnose and treat diseases. Clinical trials are extremely important because they allow researchers to work with patients suffering from the exact condition they are trying to treat.

Q. What types of clinical trials are available at Emory?

A. There are several forms of clinical trials. Some trials test new drugs, procedures or other treatments, and others look for better ways to prevent diseases in people who have either never had a disease or are trying to keep one from coming back. Some trials are used to develop better ways to diagnose a particular disease or condition while other trials help find ways to improve the care and quality of life of people with long-term illnesses.

Q. What do the different phases of trials mean?

A. Clinical trials take place in “phases,” and each phase helps researchers answer specific questions.

Phase I Clinical Trials: These trials are used to test brand new drugs, devices or procedures to find out how safe they are and identify possible side effects. They usually involve 20 to 80 people.

Phase II Clinical Trials: These trials are used to further evaluate the effectiveness and safety 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.

Phase III Clinical Trials: These trials compare a new treatment or procedure with a standard old treatment or procedure to figure out which works best. Evaluation of side effects and effectiveness continues. They usually involve 1,000 to 8,000 people.

Phase IV Clinical Trials: Once a drug or procedure is approved by the U.S. Food and Drug Administration (FDA) and made available to the public, researchers continue to study its safety to figure out the best use of the new treatment.

Q. Who can participate in clinical trials?

A. Both people in good health and people with certain diseases or conditions participate in clinical trials. People participate in trials to help researchers find better treatments, or to receive care or treatment only available as part of a clinical trial.

Q. How does clinical research make a difference?

A. Clinical research helps us learn about the safety and effectiveness of all drugs, procedures and other
treatments. Medical advances like new drugs and surgical procedures are made possible because of clinical trials and the voluntary participation of individuals.

At Emory, we’re conducting clinical trials and research to make a difference in people’s lives, here and now and for generations to come. While there are many benefits to participating in clinical trials, there can also be risks, which is why it is important to speak with a physician before deciding to participate. For more information on clinical trials at Emory, please view a complete list of our Frequently Asked Questions. If you have additional questions, visit our clinical trials website or call 404-778-7777.

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