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  Clinical Trials - Frequently Asked Questions
I have never participated in a clinical trial. What are some benefits and risks associated with participating in trials?

How is the safety of research participants protected?

What precautions are taken to protect confidentiality?

Do I have to pay to participate in trials?

Am I eligible to participate in a study?

Do I have to stop taking my current medications in order to be eligible for a treatment study?

I would like to participate in a HSG trial but do not know if there is a site near me. How can I find out where HSG trials are being conducted?

How do I decide what study is best for me?

Possible benefits include:


• providing hope for finding new treatments and a cure for HD
• working closely with doctors experienced in providing HD care
• taking an active role in HD research and one’s own health
• gaining access to investigational drugs not yet available to the general public

Possible risks include:


• making frequent trips to the study site and sometimes enduring lengthy study visits
• experiencing anxiety and distress from study participation
• realizing treatment may not provide any benefit to the participant
• experiencing side effects from the study drug

How is the safety of research participants protected?

Participant safety is the number one priority. There are multiple stages of approval which must be obtained before moving forward on any project. Every drug trial undertaken by the HSG must be reviewed by the US Food and Drug Administration (FDA), 2) the University of Rochester Research Subject Review Board, 3) the individual HSG Research site’s Institutional Review Board, and 4) a Data Safety Monitoring Board (link for #4 goes to the NIH web page defining Data Safety Monitoring Boards).

What precautions are taken to protect confidentiality?

To maintain confidentiality, identification numbers are used to identify all evaluation forms, reports, and laboratory specimens. All records containing subject information are housed in a secure location. Protection of computer systems and networks include full-time system administrators, full-time virus protection software, multiple security levels, and password protection. Patient privacy is governed by federal laws.

Do I have to pay to participate in trials?

No. There are no costs for taking part in a study. There may be some costs associated with participation such as travel, food, and time away from work. If there are financial limitations and/or concerns, it would be useful to contact the study doctor or coordinator.

Am I eligible to participate in a study?

A clinical trial is designed to answer questions pertaining to certain conditions and research questions. All studies have guidelines about who can join. Studies may include individuals who are affected with or at risk of developing symptoms of HD as well as individuals who do not have any history of HD in their family. These guidelines are established so that the study can yield reliable results and meet the objectives of the study.

Do I have to stop taking my current medications in order to be eligible for a treatment study?

It is important to discuss any decisions to stop or change your current medications with your personal physician. It is typically required that you are on a stable dose of your current medications for a certain period of time prior to participation. Depending on the drug under study certain medications may be excluded. The research team will review the list of exclusionary medications with you and help to discuss any changes.

How do I decide what study is best for me?

Finding answers and making decisions can be difficult and overwhelming. It is important to discuss your options with your doctor, other medical experts, and/or with those close to you. Feel free to discuss with the study investigator and/or coordinator the purpose of the study, the time requirements, and possible risks and/or side effects as these details vary from study to study. Find the study that you feel comfortable doing and that fits into your daily life.

Can I stop participating if I change my mind?

Yes. Participation in research is voluntary. You may choose to participate or not, and you can change your mind at any time. If you change your mind, the ideal way to make your decision about discontinuing participation is to talk to the study investigator or coordinator. They may be able to help assist with issues that may arise (i.e. transportation issues, scheduling, anxiety, etc.) so that you can remain in the study.

Does participating in a study replace my regular medical care?

No. You should continue being followed by your personal physician. During the course of a study, the study investigator provides care specifically relating to the requirements of the study design. Standard medical care such as types of procedures ordered, choices of medications and evaluations are handled by your personal physician.

Where can I find more information about clinical trials?

The following links offer more information about general research and clinical trials.
http://www.ninds.nih.gov/disorders/huntington/detail_huntington.htm
http://clinicaltrials.gov/ct2/info/resources
http://www.cc.nih.gov/participate/faqaboutcs.shtml
http://www.nlm.nih.gov/services/faqctgov.html
http://www.centerwatch.com/patient/backgrnd.html

Disclaimer: The Huntington Study Group (HSG) has provided links to internet sites maintained by third parties, over which the HSG has no control. The HSG does not endorse the content, operators, products or services of such sites, and the HSG is not responsible or liable for the content, operators, availability, accuracy, quality, advertising, products, services or other materials on or available from such sites.

What kinds of research opportunities are available through the Huntington Study Group?

Observational Studies – studies where participants are interviewed and evaluated to gain a better understanding of a particular disease. Observational studies do not involve any experimental treatments (drugs).
Treatment Trials – studies where participants are assigned to a drug or treatment. The study drug or treatment may be either a new or existing therapy to determine the safety, tolerability, and effectiveness.

 

 
  
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