Frequently Asked Questions

Before you volunteer for a research study, be sure to ask plenty of questions.  Informed consent isn't just a document you read and sign once, it is a ongoing process.  Below are some questions and answers to frequently asked questions from people interested in joining a research study.  Please let me know if you have any more questions!


What is a Clinical Trial?

Medical advances can only be made through research. Clinical trials, also called medical research or drug studies, are one important way in which progress is made. They are planned investigations involving patients, which are usually designed to test new therapies. These therapies may include new combinations of current treatments or different ways of prescribing them to see if they can be made more effective or have their side effects reduced. Each study is designed to answer scientific questions and to find new and better ways to help patients. The results help to determine what the best treatments are and help improve care for patients in the future. Before a new treatment is tried with patients, it is carefully studied in the laboratory. This research points out the new methods most likely to succeed and, as much as possible, shows how to use them safely and effectively. But, this early research cannot predict exactly how a new treatment will work with patients. With any new treatment, there may be risks as well as possible benefits. There may also be some risks that are not yet known. Clinical trials help us find out if a promising new treatment is safe and effective for patients. During a trial, more and more information is gained about a new treatment, about the possible risks and about how well it may or may not work. Standard treatments, the ones now being used, are often the base for building new, hopefully better treatments. Many new treatments are designed based on what has worked in the past, in efforts to improve on this.

Why should I participate?

There are many reasons people take part in clinical trials. As a volunteer in a clinical trial, you are participating in the development of medical therapies - therapies that may offer better treatment and even cures for life threatening diseases and chronic illnesses. People volunteer to participate in clinical trials for a number of reasons. You may get involved in a clinical trial because you simply want to contribute to a research effort that may help others; you may get involved because you are suffering from a disease or condition for which a good treatment does not currently exist; you may get involved hoping to improve the medical care you receive. If you do not have health insurance, clinical trials are a way to receive study-related medical care. Based on what researchers learn from laboratory studies, earlier clinical studies, and standard treatments as well, they design a trial to see if a new treatment will improve on current treatments. The hope is that it will. Often researchers use standard treatments as the building blocks to try to design better treatments. Although there is always a chance that a new treatment will be disappointing, the researchers involved in a study have reason to believe that it will be as good as, or better than, current treatments. The patients in a clinical trial are among the first to receive new research treatments before they are widely available. How a treatment will work for a patient in a trial can't be known ahead of time. Even standard treatments, although effective in many patients, do not carry sure benefits for everyone. But, patients should choose if they want to take part in a study or not only after they understand both the possible risks and benefits The patients who take part in clinical trial procedures that do prove to be better treatments have the first chance to benefit from them. All patients in clinical trials are carefully monitored during a trial and followed up afterwards. They become part of a network of clinical trials around the country. In this network, doctors and researchers pool their ideas and experience to design and monitor clinical studies. They share their knowledge from many specialties. Patients in these studies receive the benefits of their expertise and receive care from a special research team. Through new programs, community hospitals and doctors are also coming more and more into the research network.

Are There Risks or Side Effects in Clinical Trials?

Yes. The treatments used in clinical trials can cause side effects and other health risks depending on the type of treatment and the patients condition. Side effects vary from patient to patient. Because clinical trials are research into new areas of treatment, the risks involved are not always known ahead of time, though efforts have been made to find out what they might be. For this reason, trials can carry unknown dangers and side effects as well as hoped-for benefits. Patients need to know what is involved in a study-what side effects may be expected-and, as much as possible, what unknowns or uncertainties they may be facing. Your doctor or nurse will tell you about the treatments being tested and will give you a form to read that discusses the risks and hoped-for benefits. If you agree to take part, you will be asked to sign a form, called the informed consent form. Before you sign, be sure you understand what risks you face. Ask the doctor or nurse to explain any parts of the form or trial that are not clear. If you do not want to be in the trial, you may refuse. Even if you sign the form, you are free to leave the trial at any time and can receive other available medical care.
What Is Informed Consent?

Informed consent, a key part of a good trial, is required in studies that are federally regulated or funded as well as by many state laws. Informed consent means that as a patient, you are given information so you can understand what is involved in a trial, including its potential benefits and risks, and then decide freely to take part in it or not. The nature of the treatment is explained by the doctors and nurses in the trial. You are given an informed consent form to read and consider carefully. Ask any questions you may have. Then, if you agree to take part, you can sign the form. Of course, you can also refuse. The informed consent process is an ongoing process. If you enter a trial, you will continue to receive any new information about your treatment that may affect you willingness to stay in the trial. Signing a consent form does not bind you to the study. You can still choose to leave the study at any time.

Can You Leave a Trial at Any Time?

Yes. Just as you can refuse to join a study, you may leave a study at any time. Your rights as an individual do not change because you are a patient in a clinical trial. You may choose to take part or not, and you can always change your mind later, even after you enter a trial. You may also refuse to take part in any aspect of the research. If you have questions at any time about any part of the study, be sure to ask your doctors. If you are not satisfied with the answers, you may consider leaving the study. If you decide to leave, it will not be held against you. You can freely discuss other possible treatments and care with your doctors and nurses. 

What Protection Do You Have as a Patient in a Clinical Trial?

The ethical and legal codes that govern medical practice apply to clinical trials. In addition, most clinical research is federally regulated or federally funded (at least in part), with built-in safeguards to protect patients. These safeguards include regular review of the protocol (the study plans) and the progress of each study by researchers at other places. For example, federally funded and federally regulated clinical trials must first be approved by an Institutional Review Board (IRB) located at the institution where the study is to take place. IRBs, designed to protect patients, are made up of scientists, doctors, clergy and other people from the local community. An IRB reviews a study to see that it is well designed with safeguards for patients and that the risks are reasonable in relation to the potential benefits. Federally supported or regulated studies also go through reviews by a government agency, which sponsors and monitors many trials around the country. Any well run clinical trial, whether federally supported or not, is carefully reviewed for medical ethics, patient safety, and scientific merit by the research institution. Every study should provide for monitoring the data and the safety of patients on an ongoing basis. Informed consent is also an important process that helps to protect patients. After patients join a clinical trial and it progresses, the doctors report the results of the trial to scientific meetings, to medical journals and whose articles are approved by experts, and to various government agencies.

How Are Clinical Trials Conducted?

The doctors who conduct a clinical trial follow a carefully designed treatment plan called a "protocol." This spells out what will be done and why. Studies are planned to safeguard the medical and psychological health of patients as well as to answer research questions. Some clinical trials test one research treatment in one group of patients. Other trials compare two or more treatments in separate groups of patients who are similar in certain ways, such as the extent of their disease. This way, the treatment groups are alike and the results from each can validly be compared. One of the ways to prevent the bias of a patient or doctor from influencing study results is "randomization." If a patient agrees to be randomized, this means he or she is selected by chance to be in one group or another. The researchers do not know which treatment is best. From what is known at the time, any one of the treatments chosen could be of equal benefit to the patient. If a treatment in a trial is not helping the patient, the patient's doctor can decide to take him or her out of the study. Of course, the patient can decide to leave, as well, and still receive other available care. There are regular reviews of the results of a trial and the information is shared. This is important, because if a treatment is found to be too harmful or not effective, it is stopped. Also, when there is firm evidence that one method is better than the others in a study, the trial is stopped and all patients in the trial are given the benefit of the new information. Such information may help present and future patients. Throughout a clinical study, a patient's personal doctor will be kept informed of the patient's progress. Patients are encouraged to maintain contact with their referring doctors.

How Are Trials Divided Into Phases?

In a Phase I study, a new research treatment is given to a small number of patients. The researchers must find the best way to give a new treatment and how much of it can be given safely. They watch carefully for any harmful side effects. The research treatment has been well tested in laboratory and animal studies but no one knows how patients will react. Phase I studies may involve significant risks for this reason. Phase II studies determine the effect of a research treatment. Each new phase of a clinical trial depends on and builds on information from an earlier phase. If a treatment has shown activity against the disease in Phase II, it moves to Phase III. Here it is compared with standard treatment to see which is more effective. Often researchers use standard therapy as the base to design new, hopefully better treatments. Then in Phase III, the new treatment is directly compared to the old one. In Phase IV studies, the new research treatment becomes part of standard treatment in patient care.
How Do I Participate?

Please feel free to call our office at 501-227-6179 or email to info@clincialtrialsinc.com. Someone will ask you a few simple questions to see if you might qualify for any studies we are conducting. Medical records may be required.

How much do you pay?

We do NOT pay for your participation. There are reimbursement/compensation programs for your time and travel. Amounts vary for each study depending on study requirments. Please call for this information.

Severe Weather in Arkansas

Hey guys - I have to admit one of my major fears is Tornados.  I guess because the unknown can be scary!  We know there is a moderate chance of tornados and we take shelter, but what will the storms actually do?  The funnel cloud last night in WLR was the largest I've ever seen, but thankfully it didn't touch down.  Unfortunately for the folks in Vilonia it did and we have lost more lives with this vicious storm.  I pray that the storms coming this evening will just bring Thunderstorms and no more straight-line winds or tornados.  

REMEMBER:  Always take cover in the most interior part of your home on the lowest level, away from windows and other possible debris.  DO NOT try to drive over an area with running water, it can be very dangerous and even deadly.

http://emergency.cdc.gov/disasters/tornadoes/

Prayers to those families we have lost and to keep us safe in the upcoming storms!

New Guidelines for Diagnosing Alzheimers

NIA NEWS
For Immediate Release
Tuesday, April 19, 2011

Alzheimer's diagnostic guidelines updated for first time in decades

NIH-supported revision also proposes staging of disease, potential use of biomarkers

For the first time in 27 years, clinical diagnostic criteria for Alzheimer’s disease dementia have been revised, and research guidelines for earlier stages of the disease have been characterized to reflect a deeper understanding of the disorder. The National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease outline some new approaches for clinicians and provide scientists with more advanced guidelines for moving forward with research on diagnosis and treatments. They mark a major change in how experts think about and study Alzheimer’s disease. Development of the new guidelines was led by the National Institutes of Health and the Alzheimer’s Association.
The original criteria were the first to address the disease and described only later stages, when symptoms of dementia are already evident. The updated guidelines announced today cover the full spectrum of the disease as it gradually changes over many years. They describe the earliest preclinical stages of the disease, mild cognitive impairment, and dementia due to Alzheimer’s pathology. Importantly, the guidelines now address the use of imaging and biomarkers in blood and spinal fluid that may help determine whether changes in the brain and those in body fluids are due to Alzheimer’s disease. Biomarkers are increasingly employed in the research setting to detect onset of the disease and to track progression, but cannot yet be used routinely in clinical diagnosis without further testing and validation.
“Alzheimer’s research has greatly evolved over the past quarter of a century. Bringing the diagnostic guidelines up to speed with those advances is both a necessary and rewarding effort that will benefit patients and accelerate the pace of research,” said National Institute on Aging Director Richard J. Hodes, M.D.
“We believe that the publication of these articles is a major milestone for the field,” said William Thies, Ph.D., chief medical and scientific officer at the Alzheimer’s Association. “Our vision is that this process will result in improved diagnosis and treatment of Alzheimer’s, and will drive research that ultimately will enable us to detect and treat the disease earlier and more effectively. This would allow more people to live full, rich lives without—or with a minimum of—Alzheimer’s symptoms.”
The new guidelines appear online April 19, 2011 in Alzheimer’s & Dementia: The Journal of the Alzheimer’s Association. They were developed by expert panels convened last year by the National Institute on Aging (NIA), part of the NIH, and the Alzheimer’s Association. Preliminary recommendations were announced at the Association’s International Conference on Alzheimer’s Disease in July 2010, followed by a comment period.
Guy M. McKhann, M.D., Johns Hopkins University School of Medicine, Baltimore, and David S. Knopman, M.D., Mayo Clinic, Rochester, Minn., co-chaired the panel that revised the 1984 clinical Alzheimer’s dementia criteria. Marilyn Albert, Ph.D., Johns Hopkins University School of Medicine, headed the panel refining the MCI criteria. Reisa A. Sperling, M.D., Brigham and Women’s Hospital, Harvard Medical School, Boston, led the panel tasked with defining the preclinical stage. The journal also includes a paper by Clifford Jack, M.D., Mayo Clinic, Rochester, Minn., as senior author, on the need for and concept behind the new guidelines.
The original 1984 clinical criteria for Alzheimer’s disease, reflecting the limited knowledge of the day, defined Alzheimer’s as having a single stage, dementia, and based diagnosis solely on clinical symptoms. It assumed that people free of dementia symptoms were disease-free. Diagnosis was confirmed only at autopsy, when the hallmarks of the disease, abnormal amounts of amyloid proteins forming plaques and tau proteins forming tangles, were found in the brain.
Since then, research has determined that Alzheimer’s may cause changes in the brain a decade or more before symptoms appear and that symptoms do not always directly relate to abnormal changes in the brain caused by Alzheimer’s. For example, some older people are found to have abnormal levels of amyloid plaques in the brain at autopsy yet never showed signs of dementia during life. It also appears that amyloid deposits begin early in the disease process but that tangle formation and loss of neurons occur later and may accelerate just before clinical symptoms appear.
To reflect what has been learned, the National Institute on Aging/Alzheimer’s Association Diagnostic Guidelines for Alzheimer’s Disease cover three distinct stages of Alzheimer’s disease:

• Preclinical – The preclinical stage, for which the guidelines only apply in a research setting, describes a phase in which brain changes, including amyloid buildup and other early nerve cell changes, may already be in process. At this point, significant clinical symptoms are not yet evident. In some people, amyloid buildup can be detected with positron emission tomography (PET) scans and cerebrospinal fluid (CSF) analysis, but it is unknown what the risk for progression to Alzheimer’s dementia is for these individuals. However, use of these imaging and biomarker tests at this stage are recommended only for research. These biomarkers are still being developed and standardized and are not ready for use by clinicians in general practice.

• Mild Cognitive Impairment (MCI) – The guidelines for the MCI stage are also largely for research, although they clarify existing guidelines for MCI for use in a clinical setting. The MCI stage is marked by symptoms of memory problems, enough to be noticed and measured, but not compromising a person’s independence. People with MCI may or may not progress to Alzheimer’s dementia. Researchers will particularly focus on standardizing biomarkers for amyloid and for other possible signs of injury to the brain. Currently, biomarkers include elevated levels of tau or decreased levels of beta-amyloid in the CSF, reduced glucose uptake in the brain as determined by PET, and atrophy of certain areas of the brain as seen with structural magnetic resonance imaging (MRI). These tests will be used primarily by researchers, but may be applied in specialized clinical settings to supplement standard clinical tests to help determine possible causes of MCI symptoms.

• Alzheimer’s Dementia – These criteria apply to the final stage of the disease, and are most relevant for doctors and patients. They outline ways clinicians should approach evaluating causes and progression of cognitive decline. The guidelines also expand the concept of Alzheimer’s dementia beyond memory loss as its most central characteristic. A decline in other aspects of cognition, such as word-finding, vision/spatial issues, and impaired reasoning or judgment may be the first symptom to be noticed. At this stage, biomarker test results may be used in some cases to increase or decrease the level of certainty about a diagnosis of Alzheimer’s dementia and to distinguish Alzheimer’s dementia from other dementias, even as the validity of such tests is still under study for application and value in everyday clinical practice.

The panels purposefully left the guidelines flexible to allow for changes that could come from emerging technologies and advances in understanding of biomarkers and the disease process itself.
“The guidelines discuss biomarkers currently known, and mention others that may have future applications,” said Creighton H. Phelps, Ph.D., of the NIA Alzheimer’s Disease Centers Program. “With researchers worldwide striving to develop, validate and standardize the application of biomarkers at every stage of Alzheimer’s disease, we devised a framework flexible enough to incorporate new findings.”

###

The Alzheimer's Association is the world’s leading voluntary health organization in Alzheimer’s care, support and research. Their mission is to eliminate Alzheimer’s disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. For more information on the Association, visit http://list.niapublications.org/adearalert/lists/lt.php?id=LBoFDAUDBQUCRFVVVkxQAwkPWA%3D%3D. For more information on the new diagnostic criteria and links to the papers referenced below, visit http://list.niapublications.org/adearalert/lists/lt.php?id=LBoFDAUDBQUFRFVVVkxQAwkPWA%3D%3D. Media contact is Niles Frantz at 312-335-5777 or niles.frantz@alz.org.
The National Institute on Aging leads the federal government effort conducting and supporting research on aging and the health and well being of older people. The NIA provides information on age-related cognitive change and neurodegenerative disease specifically at its Alzheimer’s Disease Education and Referral (ADEAR) Center at http://list.niapublications.org/adearalert/lists/lt.php?id=LBoFDAUDBQUERFVVVkxQAwkPWA%3D%3D For more on health and on aging generally, go to http://list.niapublications.org/adearalert/lists/lt.php?id=LBoFDAUDBQUHRFVVVkxQAwkPWA%3D%3D. To sign up for e-mail alerts about new findings or publications, please visit either website.
About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit http://list.niapublications.org/adearalert/lists/lt.php?id=LBoFDAUDBQUGRFVVVkxQAwkPWA%3D%3D.
References:

• Clifford R. Jack Jr., et al. “Introduction to Revised Criteria for the Diagnosis of Alzheimer’s Disease: National Institute on Aging and the Alzheimer’s Association Workgroups.”
• Guy M. McKhann and David S. Knopman, et al. “The Diagnosis of Dementia due to Alzheimer’s Disease: Recommendations from the National Institute on Aging and the Alzheimer’s Association Workgroup.”
• Marilyn S. Albert, et al. “The Diagnosis of Mild Cognitive Impairment due to Alzheimer’s Disease: Recommendations from the National Institute on Aging and Alzheimer’s Association Workgroup.”
• Reisa A. Sperling, et al. “Toward Defining the Preclinical Stages of Alzheimer’s Disease: Recommendations from the National Institute on Aging and the Alzheimer’s Association Workgroup.”

ClinicalTrials_Parkinsons.wmv

Alzheimer's and a genetic link

Our current study for Alzheimer's disease tests for the APEO4 gene that has been linked to Alzheimer's.  So far, our site has learned a few things from this since it has been ongoing for 2-3 years. 

1 - There are many more gene carriers than we originally thought
2 - You may have no family history and still be a gene carrier
3 - You may have a Strong family history and Not be a gene carrier

*Some doctors still do not recommend being tested for the gene because you can be a gene carrier and still Never develop Alzheimer's disease.

What does this tell us?  We still have a lot to learn about the correlation of Alzheimer's and genetics.  Below is a link to another artile relating to this topic.  Let me know if you have any other information regarding this or any questions.

http://today.msnbc.msn.com/id/41273195/ns/today-today_health/

Let's Talk!

We have just begun with this blog but I truly hope we can turn it into something great, where folks can come and learn from others and hear about their experiences with clinical trials and particularly our clinic and Dr. Biton (the good, the bad and the ugly) but preferably the good :)

You can even give us tips on how to improve our services! 

Here is a little info on Dr. B - He started his own private practice in 1993.  The office consists of 2 clinics - Arkansas Epilepsy Program & Clinical Trials, Inc.  He has worked at all the major hospitals in Little Rock - Baptist, UAMS, VA and St. Vincent. 

Dr. B is a board certified Neurologist with added qualifications in  Clinical Neurophysiology.  He is also an Epileptologist.  He has associations with AES, AAN, AES and SNS. 

Medicine and Clinical Trials use lots of acronyms, so if I ever use any and you are unsure of what I'm talking about, please let me know!

I hope you decide to become one of our followers and invite others as well.  I'm looking forward to this new adventure....

let's talk soon
LL

***Positive results on a MS study - http://www.clinicaspace.com/news_story.aspx?NewsEntityId=216688

Welcome!

Hello!  Clinical Trials, Inc was established in 1993 and we are just now entering into the social media revolution.  Dr. Victor Biton is our Board Certified Neurologist and Director.  We are trying to reach out to those suffering with Neurological diseases such as:

Epilepsy
Alzheimer's
Parkinson's
Diabetic Neuropathy pain
MS

We want to share our studies with folks so they know about all their options.  Research is completely voluntary and is monitored by Sponsors (Pharmaceutical companies), IRB's and the FDA.  Of course, there are always risks like with any new medication you start.  However, without this research we cannot learn more about these disease and how best to treat and ultimately cure them.

Let me know what topics interest you the most and we can start discussing....until then visit our website or facebook pages.

http://www.clinicaltrialsinc.com/
http://www.facebook.com/pages/Clinical-Trials-Inc/102125223167529