clinical-trial-safety

Clinical Trials and Research

Clinical trials are research studies that look at ways to prevent, detect, or treat diseases. They are critical to understanding and treating mental illnesses.

Clinical trials are the primary way researchers determine if a new treatment is safe & effective in people.

Clinical trials can study:
  • New medications & Drugs
  • New medical devices
  • New behavioral Interventions.

People volunteer for clinical trials for many reasons. Some people join clinical trials to help doctors and reseachers. Learn nore about  a disease and improved health care.

Participating in Clinical trials is entirely up to you.  If you volunteer for a  clinical trial and later decide it’s not right for you, you can withdraw anytime.

During a Clinical trial, you will see a team of researchers, sometimes called a study team, clinical trial team, or clinical research team, who will monitor your health closely.

You may have more tests and medical exams than you would if you were getting medical health care but not participating in clinical health trial. The study team may also ask you to do other tasks, such as keeping a log about your health or filling out forms about how you feel.

Clinical trials are generally safe. Though there are risks to participating in clinical research, clinical trials are designed to minimize risks  and keep you safe.

Before a clinical trial can start, it must be reviewed and approved by an institutional review board (IRB) for U.S.-based studies or an independent ethics committee outside the U.S.

This review ensures that it is safe and that the potential benefits of the trial are worth the potential risks.

The study team also make sure you meet certain requirements and that it is safe for you to participate.

Clinical studies might make you feel a little uncomfortable for a short time, but how much risk you face depends on the type of study you join.

For instance if you are participating in a study testing a new drug, the medication might make you feel sick or tired when you first start taking it.

In some studies, instead of trying a new medicine you might take computer-based tests or have a non-invasive magnetic resonance imaging (MRI) done, which carries different risks.

Speak with the study team to understand the risks involved in a particular study. Potential risks are included in the informed consent process.

Any safety concerns should be notified to our dedicated IPMG Research Safety Number at 909-488-9116

Navigating the Path to Participation: How to Sign Up for a Clinical Trial

For many, the decision to participate in a clinical trial can feel like stepping into the unknown. But understanding the signing-up process can help demystify it and empower individuals to take charge of their health journey. Let’s walk through the typical steps involved in enrolling in a clinical trial.

Step 1: Identify the Right Clinical Trial

Research: Begin by looking for clinical trials that align with your specific health condition or treatment needs. Resources like clinicaltrials.gov, local research institutions, or hospitals can provide valuable information on available studies.

Eligibility Criteria: Each trial has specific requirements for participation, such as age, gender, type of disease, and previous treatment history. Make sure to review these criteria to determine if you might qualify.

Step 2: Contact the Research Team

Reach Out: Once you’ve found a trial that interests you, reach out to the research team. This is often done via email or phone. Don’t hesitate to ask questions about the trial’s purpose, procedures, and what to expect.

Step 3: Initial Screening

Pre-Screening Assessment: If you meet the eligibility criteria, the next step typically involves an initial assessment. This may include a phone interview or an in-person visit where you’ll provide relevant health information and medical history. This step ensures that the trial is a good fit for you.

Step 4: Informed Consent

Understanding the Trial: If you pass the initial screening, you’ll receive detailed information about the clinical trial. This will cover everything from its goals to potential risks and benefits.

Informed Consent: Before officially enrolling, you’ll be required to sign an informed consent form. This document confirms that you understand the nature of the trial and agree to participate. This crucial step ensures that you are fully aware of what’s involved.

Step 5: Enrollment and Baseline Assessments

Final Enrollment: Once you’ve signed the consent form, you’ll be officially enrolled in the trial. Depending on the study, you might undergo additional baseline assessments, such as blood tests or imaging scans.

Continuous Communication: From this point onward, you’ll be in close contact with the research team for regular check-ups and to monitor your progress throughout the study.

Step 6: Participate in the Trial

Engagement: The trial may involve receiving a new treatment, taking medications, or undergoing specific procedures. Stay engaged and communicate openly with the research team about your experiences and any side effects.

CHILD/TEEN CLINICAL TRIALS

image0

Much of a child/teen clinical trial will be similar to the process of an adult participating in a clinical trial.

The main difference is that a child or teen will be part of the informed decision making process. While the parents or guardian signs a Consent Form, the child/teen would sign an Assent Form.

An assent form is discussed with the child/teen to introduce the study, and explain it in easy- to-understand language. The freedom to disagree to participate is discussed and reassurance that not participating is in no way a bad decision and that no one will be upset with them. The assent form usually goes on to explain they can drop out at any time they choose as well as their rights to privacy.
image1
clinical-trial-safety

Clinical Trials and Research

Clinical trials are research studies that look at ways to prevent, detect, or treat diseases. They are critical to understanding and treating mental illnesses.

Clinical trials are the primary way researchers determine if a new treatment is safe & effective in people.

Clinical trials can study:
  • New medications & Drugs
  • New medical devices
  • New behavioral Interventions.

People volunteer for clinical trials for many reasons. Some people join clinical trials to help doctors and reseachers. Learn nore about  a disease and improved health care.

Participating in Clinical trials is entirely up to you.  If you volunteer for a  clinical trial and later decide it’s not right for you, you can withdraw anytime.

During a Clinical trial, you will see a team of researchers, sometimes called a study team, clinical trial team, or clinical research team, who will monitor your health closely.

You may have more tests and medical exams than you would if you were getting medical health care but not participating in clinical health trial. The study team may also ask you to do other tasks, such as keeping a log about your health or filling out forms about how you feel.

Clinical trials are generally safe. Though there are risks to participating in clinical research, clinical trials are designed to minimize risks  and keep you safe.

Before a clinical trial can start, it must be reviewed and approved by an institutional review board (IRB) for U.S.-based studies or an independent ethics committee outside the U.S.

This review ensures that it is safe and that the potential benefits of the trial are worth the potential risks.

The study team also make sure you meet certain requirements and that it is safe for you to participate.

Clinical studies might make you feel a little uncomfortable for a short time, but how much risk you face depends on the type of study you join.

For instance if you are participating in a study testing a new drug, the medication might make you feel sick or tired when you first start taking it.

In some studies, instead of trying a new medicine you might take computer-based tests or have a non-invasive magnetic resonance imaging (MRI) done, which carries different risks.

Speak with the study team to understand the risks involved in a particular study. Potential risks are included in the informed consent process.

Any safety concerns should be notified to our dedicated IPMG Research Safety Number at 909-488-9116

Navigating the Path to Participation: How to Sign Up for a Clinical Trial

For many, the decision to participate in a clinical trial can feel like stepping into the unknown. But understanding the signing-up process can help demystify it and empower individuals to take charge of their health journey. Let’s walk through the typical steps involved in enrolling in a clinical trial.

Step 1: Identify the Right Clinical Trial

Research: Begin by looking for clinical trials that align with your specific health condition or treatment needs. Resources like clinicaltrials.gov, local research institutions, or hospitals can provide valuable information on available studies.

Eligibility Criteria: Each trial has specific requirements for participation, such as age, gender, type of disease, and previous treatment history. Make sure to review these criteria to determine if you might qualify.

Step 2: Contact the Research Team

Reach Out: Once you’ve found a trial that interests you, reach out to the research team. This is often done via email or phone. Don’t hesitate to ask questions about the trial’s purpose, procedures, and what to expect.

Step 3: Initial Screening

Pre-Screening Assessment: If you meet the eligibility criteria, the next step typically involves an initial assessment. This may include a phone interview or an in-person visit where you’ll provide relevant health information and medical history. This step ensures that the trial is a good fit for you.

Step 4: Informed Consent

Understanding the Trial: If you pass the initial screening, you’ll receive detailed information about the clinical trial. This will cover everything from its goals to potential risks and benefits.

Informed Consent: Before officially enrolling, you’ll be required to sign an informed consent form. This document confirms that you understand the nature of the trial and agree to participate. This crucial step ensures that you are fully aware of what’s involved.

Step 5: Enrollment and Baseline Assessments

Final Enrollment: Once you’ve signed the consent form, you’ll be officially enrolled in the trial. Depending on the study, you might undergo additional baseline assessments, such as blood tests or imaging scans.

Continuous Communication: From this point onward, you’ll be in close contact with the research team for regular check-ups and to monitor your progress throughout the study.

Step 6: Participate in the Trial

Engagement: The trial may involve receiving a new treatment, taking medications, or undergoing specific procedures. Stay engaged and communicate openly with the research team about your experiences and any side effects.

CHILD/TEEN CLINICAL TRIALS

image0

Much of a child/teen clinical trial will be similar to the process of an adult participating in a clinical trial.

The main difference is that a child or teen will be part of the informed decision making process. While the parents or guardian signs a Consent Form, the child/teen would sign an Assent Form.

An assent form is discussed with the child/teen to introduce the study, and explain it in easy- to-understand language. The freedom to disagree to participate is discussed and reassurance that not participating is in no way a bad decision and that no one will be upset with them. The assent form usually goes on to explain they can drop out at any time they choose as well as their rights to privacy.
image1
john-kohut

John Kohut, MD

Dr. Kohut is a board-certified psychiatrist who works with patients from age 22 to the elderly providing medication management for patients with symptoms of anxiety, depression, and post-traumatic stress disorder. Dr. Kohut enjoys the opportunity of working in conjunction with psychotherapists of all fields such as licensed clinical psychologist, licensed clinical social workers, and marriage and family therapists. He works with fellow clinicians on an outpatient basis but when necessary, refers to inpatient services and consultants in various inpatient facilities in the San Bernardino and surrounding areas. Dr. Kohut has been in psychiatric practice since 1971.

Practicing locations :

john-kohut

John Kohut, MD

Dr. Kohut is a board-certified psychiatrist who works with patients from age 22 to the elderly providing medication management for patients with symptoms of anxiety, depression, and post-traumatic stress disorder. Dr. Kohut enjoys the opportunity of working in conjunction with psychotherapists of all fields such as licensed clinical psychologist, licensed clinical social workers, and marriage and family therapists. He works with fellow clinicians on an outpatient basis but when necessary, refers to inpatient services and consultants in various inpatient facilities in the San Bernardino and surrounding areas. Dr. Kohut has been in psychiatric practice since 1971.

Practicing locations :

sigrid-formantes

Sigrid Formantes, MD

Dr. Sigrid Formantes is a Board-certified general psychiatrist. She earned her medical degree at the University of the Philippines and completed her general psychiatry residency at the Brookdale Hospital and Medical Center in New York. She has been in practice since 2008 seeing adults 18 years and older.

Practicing locations :

sigrid-formantes

Sigrid Formantes, MD

Dr. Sigrid Formantes is a Board-certified general psychiatrist. She earned her medical degree at the University of the Philippines and completed her general psychiatry residency at the Brookdale Hospital and Medical Center in New York. She has been in practice since 2008 seeing adults 18 years and older.

Practicing locations :

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