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Clinical Research

Learn about the benefits of participating in clinical trials.

In this video, we address the myths and risks of research participation.

Clinical Trial FAQs

Possible benefits include:

  • providing hope for finding new treatments for HD and HD symptoms
  • 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
  • experiencing side effects from the study drug

 

 

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 HSG must be reviewed by 1) the US Food and Drug Administration (FDA), 2) a centralized Research Subject Review Board, 3) the individual HSG Research site’s Institutional Review Board, and 4) a Data Safety Monitoring Board.

To maintain confidentiality, participants are assigned identification numbers which are used on all evaluation forms, reports, and laboratory specimens. All records containing participant 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.

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 as often travel reimbursement is available to participants.

A clinical trial is designed to address certain conditions and research questions. All studies have guidelines about who can join. Studies may include individuals who are symptomatic, presymptomatic, or at risk of developing symptoms of HD. Eligibility criteria are established so that the study can yield reliable results and meet the objectives of the study.

Depending on the trial’s investigational drug, taking certain medications may be excluded. The study team will review the list of exclusionary medications with you and help to discuss any changes. 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.

Please see Find HD Trials for a listing of all HSG studies or HSG Research Sites for a listing of all credentialed HSG sites.

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. Discuss the purpose of the study, the time requirements, and possible risks and/or side effects with your study team, as these details vary from study to study. Find the study that you feel comfortable doing and that fits into your daily life.

Contact a HSG Research Site near you to discuss potential solutions.

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.

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 is still handled by your personal physician.

The following links offer more information about general research and clinical trials.

Disclaimer: The Huntington Study Group (HSG) has provided links to internet sites maintained by third parties, over which HSG has no control. HSG does not endorse the content, operators, products or services of such sites, and 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.

Observational Studies are 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).

Clinical Trials are 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.

The phase 1 trial is used to learn the “maximum tolerated dose” of a drug that does not produce unacceptable side effects. Patient volunteers are followed primarily for side effects, and not for how the drug affects their disease. The first few volunteer subjects receive low doses of the trial drug to see how the drug is tolerated and to learn how it acts in the body. The next group of volunteer subjects receives larger amounts.

The phase 2 trial involves a drug whose dose and side effects are well known. Many more volunteer subjects are tested, to define side effects, learn how it is used in the body, and learn how it helps the condition under study

The phase 3 trial compares the new drug against a commonly used drug. Some volunteer subjects will be given the new drug and some the commonly used drug. The trial is designed to find where the new drug fits in managing a particular condition.