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What is a Clinical Trial?
Before a medication can be sold for the general use in the Untied States, it
must meet stringent guidelines and standards set by the United States
Food and Drug Administration (FDA). To meet these standards, a potential
drug or medical treatment goes through several phases of testing (often
over several years) with individuals who volunteer to participate in the
study. Every prescription drug, medical device, new medical treatment in
the United States has been through this testing process. Each clinical trial
involves hundred and sometimes thousands of volunteers. Without
volunteers for clinical trials there would be now new medical treatments,
new medical devices and no prescription medications.
Before a medication can be sold for the general use in the Untied States, it
must meet stringent guidelines and standards set by the United States
Food and Drug Administration (FDA). To meet these standards, a potential
drug or medical treatment goes through several phases of testing (often
over several years) with individuals who volunteer to participate in the
study. Every prescription drug, medical device, new medical treatment in
the United States has been through this testing process. Each clinical trial
involves hundred and sometimes thousands of volunteers. Without
volunteers for clinical trials there would be now new medical treatments,
new medical devices and no prescription medications.
What types of trials are there?
Although Rhode Island Mood & Memory specializes in central nervous
system studies (CNS), such as Alzheimer's Disease, Depression,
Insomnia, and Migraine Headaches; there are many types of clinical trials
being conducted throughout the world. Hospitals, health care providers as
well as independent research companies (like RIMMRI) across the
country are always conducting medical research for various health issues
which include Diabetes, Pain Management, Hypertension, Women's
Health and Cancer just to name a few. If a known medical condition exists
then chances are there are clinical trials being conducted in this country to
develop new treatments for that particular disease.
Although Rhode Island Mood & Memory specializes in central nervous
system studies (CNS), such as Alzheimer's Disease, Depression,
Insomnia, and Migraine Headaches; there are many types of clinical trials
being conducted throughout the world. Hospitals, health care providers as
well as independent research companies (like RIMMRI) across the
country are always conducting medical research for various health issues
which include Diabetes, Pain Management, Hypertension, Women's
Health and Cancer just to name a few. If a known medical condition exists
then chances are there are clinical trials being conducted in this country to
develop new treatments for that particular disease.
What are the advantages to participating in a clinical
trial?
Rhode Island Mood & Memory has it's own laboratory and cardiology
equipment so subjects do not have to travel to other facilities for testing.
Most of the assessments completed for our various studies are done
right here at our East Providence office. Due to the nature of clinical trials,
subjects receive the latest and most advanced medications, medical
devices, and medical treatment at no cost to the subject. The medications
and medical treatments that patients receive during the course of a trial
may be a viable option or alternative to the current course of treatment that
a subject is currently under. Clinical trials often include patient
compensation for time and travel as well. The quality, frequency, and level
of care provided by a clinical trial most often exceeds a subject's
expectations.
trial?
Rhode Island Mood & Memory has it's own laboratory and cardiology
equipment so subjects do not have to travel to other facilities for testing.
Most of the assessments completed for our various studies are done
right here at our East Providence office. Due to the nature of clinical trials,
subjects receive the latest and most advanced medications, medical
devices, and medical treatment at no cost to the subject. The medications
and medical treatments that patients receive during the course of a trial
may be a viable option or alternative to the current course of treatment that
a subject is currently under. Clinical trials often include patient
compensation for time and travel as well. The quality, frequency, and level
of care provided by a clinical trial most often exceeds a subject's
expectations.
What can I expect from study visits?
Throughout a subject's participation, they will receive a good deal of
personal attention. Our first concern is always for the subject's health,
privacy, and well-being. New medications are normally tested in three to
four different phases. Each successive phase involves a greater number of
people. When being considered for participation, you will be thoroughly
instructed as to what will occur in the particular trial so you can make an
informed decision before you are accepted into a trial. All clinical trials are
different depending on the phase and the medical area being investigated.
Some of the common assessments during participation may include
laboratory testing, Electrocardiogram (ECG) collection, time spent with the
study doctor, vital sign (Blood Pressure, Height, Weight, Pulse) collection,
and some form of patient questionnaires. The collection of data varies from
study to study. For more information on what a particular study involves
please call us at 401-435-8950.
Throughout a subject's participation, they will receive a good deal of
personal attention. Our first concern is always for the subject's health,
privacy, and well-being. New medications are normally tested in three to
four different phases. Each successive phase involves a greater number of
people. When being considered for participation, you will be thoroughly
instructed as to what will occur in the particular trial so you can make an
informed decision before you are accepted into a trial. All clinical trials are
different depending on the phase and the medical area being investigated.
Some of the common assessments during participation may include
laboratory testing, Electrocardiogram (ECG) collection, time spent with the
study doctor, vital sign (Blood Pressure, Height, Weight, Pulse) collection,
and some form of patient questionnaires. The collection of data varies from
study to study. For more information on what a particular study involves
please call us at 401-435-8950.
What is the process in getting involved in a clinical trial?
Before deciding to participate in a clinical trial, you will receive a full
disclosure of the potential benefits and potential risks of participation. You
will then have the opportunity to discuss and ask questions of all the
aspects of a particular trial with our medical staff and study doctors. Once
you have been fully informed, you may then decide whether or not to
participate. You are always in charge of this decision (know as informed
consent).
If a subject decides to participate in a trial then a screening process is
involved to determine if you would be a good candidate for this trial. During
the screening process the staff would collect a medical history and the
study doctor would meet with you for a thorough examination. Study related
diagnostic tests and sometimes lab tests will be performed.
The number of times that you must visit the office is determined by the type
of trial you are in. If your particular condition does not fit in with any of the
trials we are currently conducting then we would be more than happy to put
you on our mailing list so that you can be informed of potential new trials
that may fit your appropriate condition. To be put on the mailing list please
call us at 401-435-8950.
Before deciding to participate in a clinical trial, you will receive a full
disclosure of the potential benefits and potential risks of participation. You
will then have the opportunity to discuss and ask questions of all the
aspects of a particular trial with our medical staff and study doctors. Once
you have been fully informed, you may then decide whether or not to
participate. You are always in charge of this decision (know as informed
consent).
If a subject decides to participate in a trial then a screening process is
involved to determine if you would be a good candidate for this trial. During
the screening process the staff would collect a medical history and the
study doctor would meet with you for a thorough examination. Study related
diagnostic tests and sometimes lab tests will be performed.
The number of times that you must visit the office is determined by the type
of trial you are in. If your particular condition does not fit in with any of the
trials we are currently conducting then we would be more than happy to put
you on our mailing list so that you can be informed of potential new trials
that may fit your appropriate condition. To be put on the mailing list please
call us at 401-435-8950.
Am I required to participate once I sign the informed
consent?
No, you are never required to continue in the trial once the informed
consent is signed. Clinical research is always voluntary. At any time during
the course of the trial a subject may withdraw their consent for any reason.
consent?
No, you are never required to continue in the trial once the informed
consent is signed. Clinical research is always voluntary. At any time during
the course of the trial a subject may withdraw their consent for any reason.
How will my privacy be protected?
Subjects who participate in clinical research are fiercely protected. Any
subject who participates in a trial is assigned a unique patient identifier.
The sponsor (usually a pharmaceutical company) that is conducting the
clinical trial will never receive any of your personal information. Although
Rhode Island Mood & Memory stresses the importance of consulting your
physician before participating in a clinical trial it is not required. With your
permission the study doctors would be glad to speak to your physicians to
keep them informed about the trial you are participating in.
Subjects who participate in clinical research are fiercely protected. Any
subject who participates in a trial is assigned a unique patient identifier.
The sponsor (usually a pharmaceutical company) that is conducting the
clinical trial will never receive any of your personal information. Although
Rhode Island Mood & Memory stresses the importance of consulting your
physician before participating in a clinical trial it is not required. With your
permission the study doctors would be glad to speak to your physicians to
keep them informed about the trial you are participating in.
How are clinical trials regulated?
The overall governing body of clinical trials is the Food and Drug
Administration of the United States (FDA). All clinical trials must follow
stringent guidelines regarding patient safety, privacy, confidentiality, and
ethics. All clinical studies are also overseen by an Independent Institutional
Review Board (IRB) or an ethics committee. These committees are
responsible in reviewing the ethics of clinical trials and are in place for
patient safety. These boards review changes, monitor safety data, and
grant approvals for all elements of clinical trials. The patient is well
protected during their participation and is encouraged to ask questions so
they can be informed throughout the trial.
The overall governing body of clinical trials is the Food and Drug
Administration of the United States (FDA). All clinical trials must follow
stringent guidelines regarding patient safety, privacy, confidentiality, and
ethics. All clinical studies are also overseen by an Independent Institutional
Review Board (IRB) or an ethics committee. These committees are
responsible in reviewing the ethics of clinical trials and are in place for
patient safety. These boards review changes, monitor safety data, and
grant approvals for all elements of clinical trials. The patient is well
protected during their participation and is encouraged to ask questions so
they can be informed throughout the trial.
Frequently Asked Questions about Clinical
Research
Research
Patient Information
Mary Mello, Director
Copyright © 2007 [Rhode Island
Mood & Memory Research Institute].
All rights reserved
Copyright © 2007 [Rhode Island
Mood & Memory Research Institute].
All rights reserved