Summer 2012

 

The best reasons to volunteer are all around you.

Some you love.
Some you miss.
Some you’ll never know.

What are the different types of clinical research?

Clinical trials differ depending on their intended purpose. There are several different kinds of clinical trials conducted at the NIH Clinical Center (CC). For example, some studies are designed to learn more about a disease or condition, while others are designed to test a new medicine. It is important to understand the different kinds of clinical trials so that you and your family can identify the study that you would be most interested in. Below are some descriptions of the different kinds of clinical research conducted at the CC:

Treatment—Treatment research involves an intervention such as medication, therapy, new device, or new approach to surgery or therapy. These studies test the effectiveness of new treatments, combinations of treatments, or existing treatments for new disorders.

Prevention—Prevention research studies look for better ways to prevent disorders or diseases from developing or returning. Different kinds of prevention research may study medicine, vitamins, vaccines, minerals, or lifestyle changes. These studies evaluate interventions and often involve healthy people or people who are at risk but have not yet been diagnosed with a particular disease or disorder.

Diagnostic—This kind of study is designed to help researchers find better ways to identify a specific disorder or condition. Most times, these trials involve people who have had signs or symptoms of a particular disorder.

Screening—Screening research aims to find the best ways to detect certain disorders or health conditions. Sometimes these studies involve people who do not have any signs or symptoms of the illness, but perhaps have a family history or history of exposure to the illness researchers are studying.

Quality of life—This research explores ways to improve the comfort and quality of life for individuals with a chronic illness. These studies look for new ways to decrease the number or severity of side effects of the illness or its treatment.

Genetic studies—Genetic studies aim to improve the prediction of disorders by identifying and understanding how genes and an illness may be related.

Each of the above types of studies are critical to learning more about improving human health. For more information about the CC and the different research opportunities available for patient and healthy volunteers, visit clinicalcenter.nih.gov.

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Health matters: placebos and randomization

What is a placebo or a placebo-controlled clinical trial?

Clinical trials sometimes compare a new product or therapy with another that already exists to determine if the new one is as successful as, or better than, the existing one.

In some studies, participants may be assigned to receive a placebo, which is a harmless, inactive product that resembles the test product, but without the same treatment value. Placebos allow the investigators to learn whether or not the test product being given works better than the previous treatment.

Comparing a new product with a placebo can be the fastest and most reliable way to show the new product’s therapeutic effectiveness. However, placebos are not used if a patient would be placed at risk—particularly in the study of treatments for serious illnesses—by not having effective therapy. Most of these studies compare new products with an approved therapy.

Patients will always be told if a placebo is part of a study. This information will be included in the consent form given to patients prior to entering the study. When you read the consent form, be sure that you understand what research approach is being used in the study you are entering. CC staff encourage clinical research patients to read these consent forms thoroughly, and make sure they understand the research approach and the use of placebos in the study they are entering or interested in.

What is randomization?

In clinical research studies that seek to test the effectiveness of a new therapy or intervention like a new medicine or treatment, participants may be evenly placed in different study groups. This process is known as randomization, and occurs when participants do not know the group to which they have been assigned. Typically one group receives the experimental intervention while the other receives the standard treatment or no treatment. Randomization allows researchers to compare results between two groups so that they can learn more about how to improve human health and health care.

Individuals participating in the study usually do not have a choice as to which group they will be assigned. Some participants are placed in an "experimental group" and some are placed in the "control group." Sometimes studies are known as "crossover" studies, that means that the groups switch at a designated point throughout the study and each participant will have the opportunity to be in both groups—experimental and control.

When the participants and the investigators do not know which group they are in, it is called a "single-" or "double-blind" study. This helps the patients and the investigators describe what happens throughout the study without bias.

As with the use of placebos, the study design and use of randomization will always be described in detail in the consent form.

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NIH launches Clinical Trials and You

The National Institutes of Health has launched a new educational website for people who want to know more about participating in clinical research. The NIH Clinical Trials and You website offers information on what clinical research is, why it matters, and how to get involved.

The site is home to reliable, accessible information for the public, health-care providers, and voluntary health organizations. Features include basic information, video testimonies from researchers and volunteers, downloadable resources for health-care providers, and resources to find clinical trials at the Clinical Center, through ResearchMatch.org [disclaimer], and around the world through ClinicalTrials.gov. Explore the new website at nih.gov/health/clinicaltrials/index.htm.

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Opportunities for patient volunteers	Opportunities for healthy volunteers
Hepatitis D study Study number: 12-DK-0046 If you have been diagnosed with hepatitis D, you may be eligible to participate in a study that will evaluate the safety and effectiveness of the drug lonafarnib to treat and/or to slow the progression of hepatitis D. There will be two groups in this study. One will receive the study drug, the other a placebo (a sugar pill). Participants randomly assigned to the placebo group may be offered an opportunity to join the lonafarnib treatment group. Participants must be 18 years of age or older and have been diagnosed with hepatitis D. Hepatitis B study Study number: 09-D-0039 The goal of the study is to learn more about hepatitis B and to find out what affects the ways that the disease progresses. This study lasts for five years and requires visits to the CC every three months for the first year and then every six months until the end of the study. Participants must be 18 or older. Traumatic Brain Injury study Study number: 11-NR-0213 The NIH is conducting a study to learn more about traumatic brain injury (TBI). The purpose of this study is to look for changes in the blood that may reveal the extent of brain injury and how the brain changes after injury. Participation requires two six-hour outpatient visits to the CC and will include a blood draw, magnetic resonance imaging (MRI), positron emission tomography (PET) scans of the brain, and neuropsychological tests. You may be eligible if you are 18 to 70 years old, you have a TBI or have been admitted to the emergency department with trauma resulting in injury to the brain, and your injury occurred within the last 30 days.	Research Blood Donor Program Study number: 99-CC-0168 The NIH Clinical Center Department of Transfusion Medicine is looking for healthy volunteers to participate on a regular basis in the Research Blood Donor Program. Blood samples are used in laboratory research, and participants may be asked to donate whole blood or blood components. You may be eligible if you are a healthy man or woman 18 to 65 years of age. The study involves an initial screening visit and visits for whole blood or blood component donation. Metabolism study Study number: 07-DK-0202 The National Institute of Diabetes and Digestive and Kidney Diseases is looking for volunteers who are overweight and healthy to participate in a research study. This study will investigate how the metabolism adjusts to changes in environmental temperature and whether overweight individuals have a different response to exposure to cold temperatures when compared to individuals who are not overweight. You may be eligible if you are 18 to 60 years of age and considered to be overweight or obese. The study involves one screening visit with a general health assessment and one five-day admission to the CC. Healthy women Study number: 02-C-0077 Researchers at the NIH are studying how changes in breast duct cells can lead to breast cancer. The study will look at cells from a normal breast in women who do not have breast cancer. This study requires two outpatient visits to the CC: the first determines if you are eligible to take part in this study; the second involves a procedure to collect breast duct cells. You may be eligible if you are 20-50 years of age and do not have a history of breast cancer. Healthy volunteers for TBI study Study number: 11-NR-0213 The NIH is conducting a study to learn more about traumatic brain injury (TBI). Participation requires two six-hour outpatient visits to the CC and will include a blood draw, magnetic resonance imaging (MRI), positron emission tomography (PET) scans of the brain, and neuropsychological tests. Participants must be ages 18-70.
All studies are conducted at the NIH Clinical Center in Bethesda, Maryland. There is no charge for study-related tests, medications, or treatments. Some studies listed in this newsletter may be closed to enrollment at later dates. Contact PRPL for more information at prpl@cc.nih.gov. Compensation may be provided for healthy volunteers. For more information about any of the studies listed above, please call: 1-866-444-6676 TTY: 1-866-411-1010 Se habla español

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